{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1390-2026.jsonld", "@type": "schema:Dataset", "name": "Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OPEN HEART, Model Number: CDS840150S; 7) OPEN HEART, Model Number: CDS840150T; 8) OPEN HEART, Model Number: CDS840150U; 9) OPEN HEART, Model Number: CDS840150V; 10) OPEN HEART, Model Number: CDS840150W; 11) UNIVERSAL HEART CDS, Model Number: CDS840246O; 12) GENERAL AAA #11-RF, Model Number: CDS840261AB; 13) OPEN HEART ADULT, Model Number: CDS840396AA; 14) OPEN HEART ADULT, Model Number: CDS840396AB; 15) OPEN HEART ADULT, Model Number: CDS840396X; 16) OPEN HEART ADULT, Model Number: CDS840396Y; 17) OPEN HEART CDS, Model Number: CDS840428K; 18) OPEN HEART CDS, Model Number: CDS840428L; 19) PACEMAKER CDS, Model Number: CDS980839C; 20) KIT, CVC ADD A PACK HUM-LF, Model Number: CDS982564C; 21) OPEN HEART ADULT HUM, Model Number: CDS982566K; 22) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575K; 23) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575M; 24) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575O; 25) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575P; 26) OPEN HEART, Model Number: CDS983348S; 27) HEART CABG CDS, Model Number: CDS983376Q; 28) HEART CABG CDS, Model Number: CDS983376T; 29) HEART CABG CDS, Model Number: CDS983376U; 30) HEART CABG CDS, Model Number: CDS983376V; 31) OPEN HEART CDS, Model Number: CDS983513F; 32) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786D; 33) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786F; 34) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786G; 35) PEDS CARDIAC CDS, Model Number: CDS984117F; 36) OPEN HEART CDS, Model Number: CDS984276P; 37) OPEN HEART ACCESSORY CDS, Model Number: CDS984289J; 38) OPEN HEART ACCESSORY CDS, Model Number: CDS984289K; 39) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 40) OPEN HEART ACCESSORY CDS, Model Number: CDS984289M; 41) OPEN HEART ACCESSORY CDS, Model Number: CDS984289N; 42) OPEN HEART ACCESSORY CDS, Model Number: CDS984289O; 43) OPEN HEART CDS, Model Number: CDS984355F; 44) OPEN HEART CDS, Model Number: CDS984355G; 45) OPEN HEART CDS, Model Number: CDS984355I; 46) OPEN HEART CDS, Model Number: CDS984355J; 47) OPEN HEART A, Model Number: CDS985105M; 48) OPEN HEART A, Model Number: CDS985105N; 49) OPEN HEART A, Model Number: CDS985105O; 50) VASCULAR CDS, Model Number: CDS985215C; 51) BASE HEART PACK-LF, Model Number: CVT159AA; 52) ENDO KIT, Model Number: DYKE1580B; 53) KIT VASCULAR MINOR, Model Number: DYKMBNDL11; 54) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118; 55) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; 56) KIT VASCULAR BYPASS GRAFT GENE, Model Number: DYKMBNDL120; 57) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14; 58) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14A; 59) KIT VASCULAR VNS, Model Number: DYKMBNDL152; 60) KIT VASCULAR VNS, Model Number: DYKMBNDL152A; 61) KIT THORACIC SYMPHATECTOMY, Model Number: DYKMBNDL187; 62) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189B; 63) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL191; 64) KIT VASCULAR ANGIOGRAM GENERIC, Model Number: DYKMBNDL192; 65) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL203; 66) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209A; 67) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209B; 68) CARDIAC ADULT CABG, Model Number: DYKMBNDL20A; 69) CARDIAC ADULT CABG, Model Number: DYKMBNDL20B; 70) KIT CARDIAC CSICU ADULT ECMO, Model Number: DYKMBNDL21; 71) KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23A; 72) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27A; 73) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27B; 74) KIT PEDS CARDIAC ADULT, Model Number: DYKMBNDL4", "description": "FDA recall Z-1390-2026 — Medline Industries, LP is recalling Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OPEN HEART, Model Number: CDS840150S; 7) OPEN HEART, Model Number: CDS840150T; 8) OPEN HEART, Model Number: CDS840150U; 9) OPEN HEART, Model Number: CDS840150V; 10) OPEN HEART, Model Number: CDS840150W; 11) UNIVERSAL HEART CDS, Model Number: CDS840246O; 12) GENERAL AAA #11-RF, Model Number: CDS840261AB; 13) OPEN HEART ADULT, Model Number: CDS840396AA; 14) OPEN HEART ADULT, Model Number: CDS840396AB; 15) OPEN HEART ADULT, Model Number: CDS840396X; 16) OPEN HEART ADULT, Model Number: CDS840396Y; 17) OPEN HEART CDS, Model Number: CDS840428K; 18) OPEN HEART CDS, Model Number: CDS840428L; 19) PACEMAKER CDS, Model Number: CDS980839C; 20) KIT, CVC ADD A PACK HUM-LF, Model Number: CDS982564C; 21) OPEN HEART ADULT HUM, Model Number: CDS982566K; 22) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575K; 23) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575M; 24) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575O; 25) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575P; 26) OPEN HEART, Model Number: CDS983348S; 27) HEART CABG CDS, Model Number: CDS983376Q; 28) HEART CABG CDS, Model Number: CDS983376T; 29) HEART CABG CDS, Model Number: CDS983376U; 30) HEART CABG CDS, Model Number: CDS983376V; 31) OPEN HEART CDS, Model Number: CDS983513F; 32) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786D; 33) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786F; 34) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786G; 35) PEDS CARDIAC CDS, Model Number: CDS984117F; 36) OPEN HEART CDS, Model Number: CDS984276P; 37) OPEN HEART ACCESSORY CDS, Model Number: CDS984289J; 38) OPEN HEART ACCESSORY CDS, Model Number: CDS984289K; 39) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 40) OPEN HEART ACCESSORY CDS, Model Number: CDS984289M; 41) OPEN HEART ACCESSORY CDS, Model Number: CDS984289N; 42) OPEN HEART ACCESSORY CDS, Model Number: CDS984289O; 43) OPEN HEART CDS, Model Number: CDS984355F; 44) OPEN HEART CDS, Model Number: CDS984355G; 45) OPEN HEART CDS, Model Number: CDS984355I; 46) OPEN HEART CDS, Model Number: CDS984355J; 47) OPEN HEART A, Model Number: CDS985105M; 48) OPEN HEART A, Model Number: CDS985105N; 49) OPEN HEART A, Model Number: CDS985105O; 50) VASCULAR CDS, Model Number: CDS985215C; 51) BASE HEART PACK-LF, Model Number: CVT159AA; 52) ENDO KIT, Model Number: DYKE1580B; 53) KIT VASCULAR MINOR, Model Number: DYKMBNDL11; 54) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118; 55) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; 56) KIT VASCULAR BYPASS GRAFT GENE, Model Number: DYKMBNDL120; 57) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14; 58) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14A; 59) KIT VASCULAR VNS, Model Number: DYKMBNDL152; 60) KIT VASCULAR VNS, Model Number: DYKMBNDL152A; 61) KIT THORACIC SYMPHATECTOMY, Model Number: DYKMBNDL187; 62) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189B; 63) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL191; 64) KIT VASCULAR ANGIOGRAM GENERIC, Model Number: DYKMBNDL192; 65) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL203; 66) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209A; 67) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209B; 68) CARDIAC ADULT CABG, Model Number: DYKMBNDL20A; 69) CARDIAC ADULT CABG, Model Number: DYKMBNDL20B; 70) KIT CARDIAC CSICU ADULT ECMO, Model Number: DYKMBNDL21; 71) KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23A; 72) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27A; 73) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27B; 74) KIT PEDS CARDIAC ADULT, Model Number: DYKMBNDL4 (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.", "license": "https://creativecommons.org/publicdomain/zero/1.0/", "isAccessibleForFree": true, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "dateModified": "2026-06-24T07:02:03.626072+00:00", "isBasedOn": { "@type": "schema:Dataset", "name": "openFDA drug & device enforcement (recall) reports", "url": "https://open.fda.gov/apis/drug/enforcement/", "creator": { "@type": "schema:GovernmentOrganization", "name": "U.S. Food & Drug Administration" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1390-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OPEN HEART, Model Number: CDS840150S; 7) OPEN HEART, Model Number: CDS840150T; 8) OPEN HEART, Model Number: CDS840150U; 9) OPEN HEART, Model Number: CDS840150V; 10) OPEN HEART, Model Number: CDS840150W; 11) UNIVERSAL HEART CDS, Model Number: CDS840246O; 12) GENERAL AAA #11-RF, Model Number: CDS840261AB; 13) OPEN HEART ADULT, Model Number: CDS840396AA; 14) OPEN HEART ADULT, Model Number: CDS840396AB; 15) OPEN HEART ADULT, Model Number: CDS840396X; 16) OPEN HEART ADULT, Model Number: CDS840396Y; 17) OPEN HEART CDS, Model Number: CDS840428K; 18) OPEN HEART CDS, Model Number: CDS840428L; 19) PACEMAKER CDS, Model Number: CDS980839C; 20) KIT, CVC ADD A PACK HUM-LF, Model Number: CDS982564C; 21) OPEN HEART ADULT HUM, Model Number: CDS982566K; 22) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575K; 23) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575M; 24) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575O; 25) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575P; 26) OPEN HEART, Model Number: CDS983348S; 27) HEART CABG CDS, Model Number: CDS983376Q; 28) HEART CABG CDS, Model Number: CDS983376T; 29) HEART CABG CDS, Model Number: CDS983376U; 30) HEART CABG CDS, Model Number: CDS983376V; 31) OPEN HEART CDS, Model Number: CDS983513F; 32) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786D; 33) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786F; 34) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786G; 35) PEDS CARDIAC CDS, Model Number: CDS984117F; 36) OPEN HEART CDS, Model Number: CDS984276P; 37) OPEN HEART ACCESSORY CDS, Model Number: CDS984289J; 38) OPEN HEART ACCESSORY CDS, Model Number: CDS984289K; 39) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 40) OPEN HEART ACCESSORY CDS, Model Number: CDS984289M; 41) OPEN HEART ACCESSORY CDS, Model Number: CDS984289N; 42) OPEN HEART ACCESSORY CDS, Model Number: CDS984289O; 43) OPEN HEART CDS, Model Number: CDS984355F; 44) OPEN HEART CDS, Model Number: CDS984355G; 45) OPEN HEART CDS, Model Number: CDS984355I; 46) OPEN HEART CDS, Model Number: CDS984355J; 47) OPEN HEART A, Model Number: CDS985105M; 48) OPEN HEART A, Model Number: CDS985105N; 49) OPEN HEART A, Model Number: CDS985105O; 50) VASCULAR CDS, Model Number: CDS985215C; 51) BASE HEART PACK-LF, Model Number: CVT159AA; 52) ENDO KIT, Model Number: DYKE1580B; 53) KIT VASCULAR MINOR, Model Number: DYKMBNDL11; 54) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118; 55) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; 56) KIT VASCULAR BYPASS GRAFT GENE, Model Number: DYKMBNDL120; 57) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14; 58) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14A; 59) KIT VASCULAR VNS, Model Number: DYKMBNDL152; 60) KIT VASCULAR VNS, Model Number: DYKMBNDL152A; 61) KIT THORACIC SYMPHATECTOMY, Model Number: DYKMBNDL187; 62) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189B; 63) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL191; 64) KIT VASCULAR ANGIOGRAM GENERIC, Model Number: DYKMBNDL192; 65) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL203; 66) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209A; 67) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209B; 68) CARDIAC ADULT CABG, Model Number: DYKMBNDL20A; 69) CARDIAC ADULT CABG, Model Number: DYKMBNDL20B; 70) KIT CARDIAC CSICU ADULT ECMO, Model Number: DYKMBNDL21; 71) KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23A; 72) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27A; 73) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27B; 74) KIT PEDS CARDIAC ADULT, Model Number: DYKMBNDL4", "manufacturer": { "@type": "schema:Organization", "name": "Medline Industries, LP" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1390-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1390-2026: Medline Industries, LP is recalling Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OPEN HEART, Model Number: CDS840150S; 7) OPEN HEART, Model Number: CDS840150T; 8) OPEN HEART, Model Number: CDS840150U; 9) OPEN HEART, Model Number: CDS840150V; 10) OPEN HEART, Model Number: CDS840150W; 11) UNIVERSAL HEART CDS, Model Number: CDS840246O; 12) GENERAL AAA #11-RF, Model Number: CDS840261AB; 13) OPEN HEART ADULT, Model Number: CDS840396AA; 14) OPEN HEART ADULT, Model Number: CDS840396AB; 15) OPEN HEART ADULT, Model Number: CDS840396X; 16) OPEN HEART ADULT, Model Number: CDS840396Y; 17) OPEN HEART CDS, Model Number: CDS840428K; 18) OPEN HEART CDS, Model Number: CDS840428L; 19) PACEMAKER CDS, Model Number: CDS980839C; 20) KIT, CVC ADD A PACK HUM-LF, Model Number: CDS982564C; 21) OPEN HEART ADULT HUM, Model Number: CDS982566K; 22) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575K; 23) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575M; 24) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575O; 25) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575P; 26) OPEN HEART, Model Number: CDS983348S; 27) HEART CABG CDS, Model Number: CDS983376Q; 28) HEART CABG CDS, Model Number: CDS983376T; 29) HEART CABG CDS, Model Number: CDS983376U; 30) HEART CABG CDS, Model Number: CDS983376V; 31) OPEN HEART CDS, Model Number: CDS983513F; 32) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786D; 33) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786F; 34) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786G; 35) PEDS CARDIAC CDS, Model Number: CDS984117F; 36) OPEN HEART CDS, Model Number: CDS984276P; 37) OPEN HEART ACCESSORY CDS, Model Number: CDS984289J; 38) OPEN HEART ACCESSORY CDS, Model Number: CDS984289K; 39) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 40) OPEN HEART ACCESSORY CDS, Model Number: CDS984289M; 41) OPEN HEART ACCESSORY CDS, Model Number: CDS984289N; 42) OPEN HEART ACCESSORY CDS, Model Number: CDS984289O; 43) OPEN HEART CDS, Model Number: CDS984355F; 44) OPEN HEART CDS, Model Number: CDS984355G; 45) OPEN HEART CDS, Model Number: CDS984355I; 46) OPEN HEART CDS, Model Number: CDS984355J; 47) OPEN HEART A, Model Number: CDS985105M; 48) OPEN HEART A, Model Number: CDS985105N; 49) OPEN HEART A, Model Number: CDS985105O; 50) VASCULAR CDS, Model Number: CDS985215C; 51) BASE HEART PACK-LF, Model Number: CVT159AA; 52) ENDO KIT, Model Number: DYKE1580B; 53) KIT VASCULAR MINOR, Model Number: DYKMBNDL11; 54) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118; 55) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; 56) KIT VASCULAR BYPASS GRAFT GENE, Model Number: DYKMBNDL120; 57) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14; 58) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14A; 59) KIT VASCULAR VNS, Model Number: DYKMBNDL152; 60) KIT VASCULAR VNS, Model Number: DYKMBNDL152A; 61) KIT THORACIC SYMPHATECTOMY, Model Number: DYKMBNDL187; 62) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189B; 63) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL191; 64) KIT VASCULAR ANGIOGRAM GENERIC, Model Number: DYKMBNDL192; 65) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL203; 66) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209A; 67) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209B; 68) CARDIAC ADULT CABG, Model Number: DYKMBNDL20A; 69) CARDIAC ADULT CABG, Model Number: DYKMBNDL20B; 70) KIT CARDIAC CSICU ADULT ECMO, Model Number: DYKMBNDL21; 71) KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23A; 72) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27A; 73) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27B; 74) KIT PEDS CARDIAC ADULT, Model Number: DYKMBNDL4", "text": "The FDA logged enforcement record Z-1390-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OPEN HEART, Model Number: CDS840150S; 7) OPEN HEART, Model Number: CDS840150T; 8) OPEN HEART, Model Number: CDS840150U; 9) OPEN HEART, Model Number: CDS840150V; 10) OPEN HEART, Model Number: CDS840150W; 11) UNIVERSAL HEART CDS, Model Number: CDS840246O; 12) GENERAL AAA #11-RF, Model Number: CDS840261AB; 13) OPEN HEART ADULT, Model Number: CDS840396AA; 14) OPEN HEART ADULT, Model Number: CDS840396AB; 15) OPEN HEART ADULT, Model Number: CDS840396X; 16) OPEN HEART ADULT, Model Number: CDS840396Y; 17) OPEN HEART CDS, Model Number: CDS840428K; 18) OPEN HEART CDS, Model Number: CDS840428L; 19) PACEMAKER CDS, Model Number: CDS980839C; 20) KIT, CVC ADD A PACK HUM-LF, Model Number: CDS982564C; 21) OPEN HEART ADULT HUM, Model Number: CDS982566K; 22) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575K; 23) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575M; 24) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575O; 25) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575P; 26) OPEN HEART, Model Number: CDS983348S; 27) HEART CABG CDS, Model Number: CDS983376Q; 28) HEART CABG CDS, Model Number: CDS983376T; 29) HEART CABG CDS, Model Number: CDS983376U; 30) HEART CABG CDS, Model Number: CDS983376V; 31) OPEN HEART CDS, Model Number: CDS983513F; 32) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786D; 33) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786F; 34) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786G; 35) PEDS CARDIAC CDS, Model Number: CDS984117F; 36) OPEN HEART CDS, Model Number: CDS984276P; 37) OPEN HEART ACCESSORY CDS, Model Number: CDS984289J; 38) OPEN HEART ACCESSORY CDS, Model Number: CDS984289K; 39) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 40) OPEN HEART ACCESSORY CDS, Model Number: CDS984289M; 41) OPEN HEART ACCESSORY CDS, Model Number: CDS984289N; 42) OPEN HEART ACCESSORY CDS, Model Number: CDS984289O; 43) OPEN HEART CDS, Model Number: CDS984355F; 44) OPEN HEART CDS, Model Number: CDS984355G; 45) OPEN HEART CDS, Model Number: CDS984355I; 46) OPEN HEART CDS, Model Number: CDS984355J; 47) OPEN HEART A, Model Number: CDS985105M; 48) OPEN HEART A, Model Number: CDS985105N; 49) OPEN HEART A, Model Number: CDS985105O; 50) VASCULAR CDS, Model Number: CDS985215C; 51) BASE HEART PACK-LF, Model Number: CVT159AA; 52) ENDO KIT, Model Number: DYKE1580B; 53) KIT VASCULAR MINOR, Model Number: DYKMBNDL11; 54) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118; 55) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; 56) KIT VASCULAR BYPASS GRAFT GENE, Model Number: DYKMBNDL120; 57) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14; 58) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14A; 59) KIT VASCULAR VNS, Model Number: DYKMBNDL152; 60) KIT VASCULAR VNS, Model Number: DYKMBNDL152A; 61) KIT THORACIC SYMPHATECTOMY, Model Number: DYKMBNDL187; 62) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189B; 63) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL191; 64) KIT VASCULAR ANGIOGRAM GENERIC, Model Number: DYKMBNDL192; 65) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL203; 66) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209A; 67) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209B; 68) CARDIAC ADULT CABG, Model Number: DYKMBNDL20A; 69) CARDIAC ADULT CABG, Model Number: DYKMBNDL20B; 70) KIT CARDIAC CSICU ADULT ECMO, Model Number: DYKMBNDL21; 71) KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23A; 72) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27A; 73) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27B; 74) KIT PEDS CARDIAC ADULT, Model Number: DYKMBNDL4 — reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-01-07. Affected lots/codes: 1) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case), Lot Number: 23FLA191; 2) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23LBM199; 3) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23KBM369; 4) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23JBU616; 5) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ759; 6) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ571; 7) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23GBA105; 8) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23CBO830; 9) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABM709; 10) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABE738; 11) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22OBM690; 12) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBW565; 13) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBL256; 14) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBJ798; 15) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBU353; 16) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBT770; 17) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22HBU935; 18) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22GBQ917; 19) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22EBK678; 20) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22CBC309; 21) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21LBV113; 22) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21KBW667; 23) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21IBG586; 24) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21GBH886; 25) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21EBN817; 26) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21CKA394; 27) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21ELA419; 28) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21DLA296; 29) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23ELA870; 30) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24KLA701; 31) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21EBK732; 32) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21DBA306; 33) CDS840150T, UDI-DI: 10193489996197(each), 40193489996198(case), Lot Number: 21JBA896; 34) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22LBS336; 35) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22JBD465; 36) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22GBD762; 37) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22EBL398; 38) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22CBF996; 39) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22ABA269; 40) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 24ABJ652; 41) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC879; 42) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC675; 43) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23HBJ716; 44) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23EBB628; 45) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23DBN632; 46) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24FBP521; 47) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24FBP520; 48) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24EBK094; 49) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24DBB189; 50) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24CBQ331; 51) CDS840246O, UDI-DI: 10198459095955(each), 40198459095956(case), Lot Number: 25BLA225; 52) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25EBF565; 53) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25CBO300; 54) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25ABU765; 55) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25ABA041; 56) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24LBK995; 57) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24JBJ413; 58) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24IBM204; 59) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24GBQ632; 60) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24FBS248; 61) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBU862; 62) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBK620; 63) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBF421; 64) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24ABB897; 65) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23LBK827; 66) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23JBM632; 67) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23GBJ781; 68) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23FBQ953; 69) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23FBF165; 70) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23DBE827; 71) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23ABG192; 72) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22OBA486; 73) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22KBO918; 74) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22IBE745; 75) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22FBX514; 76) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22FBL409; 77) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25HBM750; 78) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25FBD477; 79) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25JBQ605; 80) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25IBD204; 81) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABL893; 82) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABK089; 83) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABC933; 84) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23GBQ865; 85) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23GBN891; 86) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23BBG436; 87) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23ABG179; 88) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23ABF773; 89) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG079; 90) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG077; 91) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG072; 92) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22FBF451; 93) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22FBF439; 94) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22DBL431; 95) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22ABE659; 96) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22ABE658; 97) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21KBQ156; 98) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21IBO083; 99) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21HBO916; 100) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21CBG242; 101) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBK781; 102) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBD493; 103) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBP788; 104) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 105) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 106) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 107) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBS930; 108) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBJ654; 109) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24CBR417; 110) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24BBO585; 111) CDS840428K, UDI-DI: 10884389911235(each), 40884389911236(case), Lot Number: 21GBS209; 112) CDS840428K, UDI-DI: 10884389911235(each), 40884389911236(case), Lot Number: 21BBH224; 113) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25DBQ683; 114) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25CBI244; 115) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25BBM940; 116) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25BBF438; 117) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24JBS428; 118) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24HBL828; 119) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24GBU141; 120) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24EBC679; 121) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24CBB817; 122) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24ABX492; 123) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23EBU791; 124) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23EBA214; 125) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23CBR891; 126) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22KBW189; 127) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22IBV957; 128) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22HBA238; 129) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22GLA269; 130) CDS980839C, UDI-DI: 10193489723076(each), 40193489723077(case), Lot Number: 21FBB093; 131) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 25CMJ833; 132) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 25BMD423; 133) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24JMF683; 134) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24HMA337; 135) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24EMG641; 136) CDS982566K, UDI-DI: 10193489435597(each), 40193489435598(case), Lot Number: 21CBQ731; 137) CDS982575K, UDI-DI: 10193489734799(each), 40193489734790(case), Lot Number: 21BKA040; 138) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21JBS146; 139) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21JBQ075; 140) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21HBQ086; 141) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21HBF470; 142) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21GBK054; 143) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21EKA064; 144) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21DKA457; 145) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22LBS833; 146) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22JBP075; 147) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22IBU776; 148) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22GBM066; 149) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22FBF335; 150) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22EBL281; 151) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22DBI104; 152) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22BBQ149; 153) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 24BBB783; 154) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23LBS018; 155) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23KBK940; 156) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23IBP737; 157) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23HBT093; 158) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23HBF574; 159) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23FBU058; 160) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23FBL415; 161) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23CBT572; 162) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23CBL429; 163) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21FBF717; 164) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21EBC025; 165) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21DBP216; 166) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21CBK379; 167) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23IBR206; 168) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23FBU833; 169) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25DMH143; 170) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25DME288; 171) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25CME797; 172) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25HMA016; 173) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25GMG706; 174) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25GME704; 175) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25LMH340; 176) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25LMF022; 177) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25IMH581; 178) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 23BBE439; 179) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22KBI289; 180) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22IBD426; 181) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22HBI664; 182) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 21FBF442; 183) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 24CME689; 184) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 24AMD733; 185) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23KMC560; 186) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23HMC461; 187) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23GMH171; 188) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23GMG766; 189) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23FMI141; 190) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23EMF372; 191) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23DMH027; 192) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22KMH072; 193) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22JMB563; 194) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22HMF199; 195) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22HMB738; 196) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22FMC683; 197) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22CMB854; 198) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21LMA822; 199) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21KMA019; 200) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21JMB643; 201) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21IMH924; 202) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21GMC871; 203) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21FMD794; 204) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21AKA832; 205) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24JMF693; 206) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24JMC120; 207) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24IMG956; 208) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24IMB935; 209) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25KMI896; 210) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25JME849; 211) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25BMD134; 212) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 24LMC522; 213) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 23BBJ754; 214) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 23ABA881; 215) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22OBL943; 216) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22JBU821; 217) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22EBM615; 218) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21KMH819; 219) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21KMC359; 220) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21IMC057; 221) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21GME785; 222) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21GBA694; 223) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21BKA482; 224) CDS984276P, UDI-DI: 10195327446802(each), 40195327446803(case), Lot Number: 24LMC474; 225) CDS984276P, UDI-DI: 10195327446802(each), 40195327446803(case), Lot Number: 24KMC946; 226) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21KLB205; 227) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21ILA628; 228) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21HLA680; 229) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLB087; 230) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLA312; 231) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLA057; 232) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21FLA954; 233) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21EKA147; 234) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21DKA676; 235) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21BKA389; 236) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23FBV540; 237) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23FBP065; 238) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23ABP719; 239) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22OBI364; 240) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22LBQ630; 241) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22JBT625; 242) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22IBT454; 243) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22HBL442; 244) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22FBX071; 245) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22EBL445; 246) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22ABF746; 247) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24EBT292; 248) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24DBU415; 249) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24CBO822; 250) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24CBL931; 251) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23LBB141; 252) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23KBA264; 253) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23JBB129; 254) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24LBA755; 255) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24KBN423; 256) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24KBA684; 257) CDS984289N, UDI-DI: 10198459256769(each), 40198459256760(case), Lot Number: 25FBD048; 258) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBL186; 259) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBC732; 260) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBB599; 261) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25GBY100; 262) CDS984355F, UDI-DI: 10888277770348(each), 40888277770349(case), Lot Number: 20LKB341; 263) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23LLA067; 264) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23JLA617; 265) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23ILB099; 266) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23HLA237; 267) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23CLA762; 268) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23CLA569; 269) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22LLA693; 270) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22LLA544; 271) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22JLB146; 272) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22ILB092; 273) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22ILA721; 274) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22FLA187; 275) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22BLA378; 276) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21HLA543; 277) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21HLA499; 278) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21GLA223; 279) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21FLA649; 280) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21EKA150; 281) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21DKA538; 282) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21DKA352; 283) CDS984355I, UDI-DI: 10195327569518(each), 40195327569519(case), Lot Number: 24ELA326; 284) CDS984355I, UDI-DI: 10195327569518(each), 40195327569519(case), Lot Number: 24BLA231; 285) CDS984355J, UDI-DI: 10198459096228(each), 40198459096229(case), Lot Number: 24LLA698; 286) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21FBE255; 287) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21BBS510; 288) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21ABE734; 289) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21LBP381; 290) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21JBZ656; 291) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21IBO615; 292) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21HBD158; 293) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23JBT159; 294) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23HBP383; 295) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23FBV374; 296) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23EBS635; 297) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23DBR889; 298) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23ABT277; 299) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22LBD272; 300) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22JBP078; 301) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22JBD236; 302) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22IBT102; 303) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22IBE901; 304) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22GBU933; 305) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22DBS062; 306) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22BBS888; 307) CDS985215C, UDI-DI: 10193489780109(each), 40193489780100(case), Lot Number: 21DBH711; 308) CVT159AA, UDI-DI: 10193489457513(each), 40193489457514(case), Lot Number: 22DBL279; 309) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24FBJ229; 310) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24DBF439; 311) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24BBT324; 312) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23JBP216; 313) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23IBI960; 314) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23GBI903; 315) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23EBO066; 316) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23DBT226; 317) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22LBD173; 318) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22KBA324; 319) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22IBA742; 320) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22GBL773; 321) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22EBS701; 322) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22BBI986; 323) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22BBF497; 324) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21KBI013; 325) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21IBQ531; 326) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21HBC943; 327) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21FBO379; 328) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBW789; 329) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBW788; 330) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBV599; 331) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBK912; 332) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21HBL002; 333) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21GBO480; 334) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21GBJ355; 335) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21FBO542; 336) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21FBF909; 337) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBN048; 338) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBC538; 339) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBA605; 340) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBS016; 341) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBO740; 342) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBM813; 343) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBF850; 344) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21BBN597; 345) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21ABO823; 346) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21ABI967; 347) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22HLA262; 348) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22FLB050; 349) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22FLA352; 350) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ELB070; 351) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ELA030; 352) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22DLA405; 353) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22CLA548; 354) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22BLB034; 355) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ALA723; 356) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ALA370; 357) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21KLA410; 358) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21HLB002; 359) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21GLA991; 360) DYKMBNDL. A RECORDED FDA enforcement action (occurred=true).", "claimType": "official_fact", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": true, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "SourceCitation", "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1390-2026&lang=eng", "value": "Devices recall, status Ongoing", "adjudicator": { "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1390-2026&lang=eng" } }, "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1390-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1390-2026 as Class II", "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.", "claimType": "regulatory_determination", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "AdjudicativeAct", "source": "U.S. FDA recall classification (openFDA enforcement)", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1390-2026&lang=eng", "value": "Class II", "adjudicator": { "name": "U.S. FDA recall classification (openFDA enforcement)", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1390-2026&lang=eng" } }, "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1390-2026/boundary", "@type": "schema:Claim", "name": "What an FDA recall is — and is NOT", "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.", "claimType": "interpretation", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": false, "operative": true }, "grounding": { "groundingType": "Interpretation", "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)", "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "value": "a recorded enforcement action, not proof of harm or causation; not medical advice", "adjudicator": null }, "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-1390-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1390-2026", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class II", "Status": "determination" } }, { "@type": "schema:ListItem", "position": 4, "item": { "Field": "Status", "Value": "Ongoing — the recall is still being carried out.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 5, "item": { "Field": "Recalling firm", "Value": "Medline Industries, LP", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2026-01-07", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "1) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case), Lot Number: 23FLA191; 2) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23LBM199; 3) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23KBM369; 4) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23JBU616; 5) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ759; 6) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ571; 7) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23GBA105; 8) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23CBO830; 9) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABM709; 10) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABE738; 11) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22OBM690; 12) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBW565; 13) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBL256; 14) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBJ798; 15) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBU353; 16) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBT770; 17) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22HBU935; 18) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22GBQ917; 19) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22EBK678; 20) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22CBC309; 21) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21LBV113; 22) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21KBW667; 23) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21IBG586; 24) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21GBH886; 25) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21EBN817; 26) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21CKA394; 27) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21ELA419; 28) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21DLA296; 29) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23ELA870; 30) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24KLA701; 31) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21EBK732; 32) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21DBA306; 33) CDS840150T, UDI-DI: 10193489996197(each), 40193489996198(case), Lot Number: 21JBA896; 34) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22LBS336; 35) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22JBD465; 36) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22GBD762; 37) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22EBL398; 38) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22CBF996; 39) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22ABA269; 40) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 24ABJ652; 41) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC879; 42) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC675; 43) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23HBJ716; 44) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23EBB628; 45) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23DBN632; 46) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24FBP521; 47) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24FBP520; 48) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24EBK094; 49) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24DBB189; 50) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24CBQ331; 51) CDS840246O, UDI-DI: 10198459095955(each), 40198459095956(case), Lot Number: 25BLA225; 52) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25EBF565; 53) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25CBO300; 54) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25ABU765; 55) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25ABA041; 56) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24LBK995; 57) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24JBJ413; 58) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24IBM204; 59) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24GBQ632; 60) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24FBS248; 61) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBU862; 62) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBK620; 63) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBF421; 64) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24ABB897; 65) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23LBK827; 66) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23JBM632; 67) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23GBJ781; 68) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23FBQ953; 69) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23FBF165; 70) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23DBE827; 71) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23ABG192; 72) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22OBA486; 73) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22KBO918; 74) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22IBE745; 75) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22FBX514; 76) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22FBL409; 77) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25HBM750; 78) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25FBD477; 79) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25JBQ605; 80) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25IBD204; 81) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABL893; 82) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABK089; 83) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABC933; 84) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23GBQ865; 85) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23GBN891; 86) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23BBG436; 87) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23ABG179; 88) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23ABF773; 89) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG079; 90) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG077; 91) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG072; 92) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22FBF451; 93) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22FBF439; 94) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22DBL431; 95) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22ABE659; 96) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22ABE658; 97) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21KBQ156; 98) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21IBO083; 99) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21HBO916; 100) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21CBG242; 101) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBK781; 102) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBD493; 103) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBP788; 104) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 105) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 106) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 107) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBS930; 108) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBJ654; 109) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24CBR417; 110) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24BBO585; 111) CDS840428K, UDI-DI: 10884389911235(each), 40884389911236(case), Lot Number: 21GBS209; 112) CDS840428K, UDI-DI: 10884389911235(each), 40884389911236(case), Lot Number: 21BBH224; 113) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25DBQ683; 114) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25CBI244; 115) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25BBM940; 116) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25BBF438; 117) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24JBS428; 118) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24HBL828; 119) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24GBU141; 120) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24EBC679; 121) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24CBB817; 122) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24ABX492; 123) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23EBU791; 124) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23EBA214; 125) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23CBR891; 126) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22KBW189; 127) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22IBV957; 128) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22HBA238; 129) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22GLA269; 130) CDS980839C, UDI-DI: 10193489723076(each), 40193489723077(case), Lot Number: 21FBB093; 131) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 25CMJ833; 132) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 25BMD423; 133) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24JMF683; 134) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24HMA337; 135) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24EMG641; 136) CDS982566K, UDI-DI: 10193489435597(each), 40193489435598(case), Lot Number: 21CBQ731; 137) CDS982575K, UDI-DI: 10193489734799(each), 40193489734790(case), Lot Number: 21BKA040; 138) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21JBS146; 139) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21JBQ075; 140) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21HBQ086; 141) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21HBF470; 142) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21GBK054; 143) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21EKA064; 144) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21DKA457; 145) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22LBS833; 146) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22JBP075; 147) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22IBU776; 148) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22GBM066; 149) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22FBF335; 150) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22EBL281; 151) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22DBI104; 152) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22BBQ149; 153) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 24BBB783; 154) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23LBS018; 155) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23KBK940; 156) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23IBP737; 157) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23HBT093; 158) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23HBF574; 159) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23FBU058; 160) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23FBL415; 161) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23CBT572; 162) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23CBL429; 163) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21FBF717; 164) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21EBC025; 165) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21DBP216; 166) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21CBK379; 167) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23IBR206; 168) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23FBU833; 169) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25DMH143; 170) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25DME288; 171) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25CME797; 172) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25HMA016; 173) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25GMG706; 174) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25GME704; 175) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25LMH340; 176) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25LMF022; 177) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25IMH581; 178) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 23BBE439; 179) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22KBI289; 180) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22IBD426; 181) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22HBI664; 182) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 21FBF442; 183) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 24CME689; 184) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 24AMD733; 185) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23KMC560; 186) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23HMC461; 187) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23GMH171; 188) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23GMG766; 189) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23FMI141; 190) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23EMF372; 191) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23DMH027; 192) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22KMH072; 193) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22JMB563; 194) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22HMF199; 195) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22HMB738; 196) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22FMC683; 197) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22CMB854; 198) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21LMA822; 199) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21KMA019; 200) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21JMB643; 201) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21IMH924; 202) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21GMC871; 203) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21FMD794; 204) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21AKA832; 205) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24JMF693; 206) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24JMC120; 207) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24IMG956; 208) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24IMB935; 209) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25KMI896; 210) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25JME849; 211) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25BMD134; 212) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 24LMC522; 213) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 23BBJ754; 214) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 23ABA881; 215) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22OBL943; 216) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22JBU821; 217) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22EBM615; 218) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21KMH819; 219) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21KMC359; 220) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21IMC057; 221) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21GME785; 222) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21GBA694; 223) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21BKA482; 224) CDS984276P, UDI-DI: 10195327446802(each), 40195327446803(case), Lot Number: 24LMC474; 225) CDS984276P, UDI-DI: 10195327446802(each), 40195327446803(case), Lot Number: 24KMC946; 226) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21KLB205; 227) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21ILA628; 228) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21HLA680; 229) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLB087; 230) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLA312; 231) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLA057; 232) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21FLA954; 233) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21EKA147; 234) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21DKA676; 235) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21BKA389; 236) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23FBV540; 237) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23FBP065; 238) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23ABP719; 239) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22OBI364; 240) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22LBQ630; 241) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22JBT625; 242) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22IBT454; 243) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22HBL442; 244) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22FBX071; 245) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22EBL445; 246) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22ABF746; 247) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24EBT292; 248) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24DBU415; 249) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24CBO822; 250) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24CBL931; 251) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23LBB141; 252) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23KBA264; 253) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23JBB129; 254) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24LBA755; 255) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24KBN423; 256) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24KBA684; 257) CDS984289N, UDI-DI: 10198459256769(each), 40198459256760(case), Lot Number: 25FBD048; 258) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBL186; 259) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBC732; 260) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBB599; 261) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25GBY100; 262) CDS984355F, UDI-DI: 10888277770348(each), 40888277770349(case), Lot Number: 20LKB341; 263) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23LLA067; 264) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23JLA617; 265) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23ILB099; 266) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23HLA237; 267) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23CLA762; 268) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23CLA569; 269) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22LLA693; 270) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22LLA544; 271) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22JLB146; 272) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22ILB092; 273) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22ILA721; 274) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22FLA187; 275) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22BLA378; 276) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21HLA543; 277) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21HLA499; 278) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21GLA223; 279) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21FLA649; 280) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21EKA150; 281) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21DKA538; 282) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21DKA352; 283) CDS984355I, UDI-DI: 10195327569518(each), 40195327569519(case), Lot Number: 24ELA326; 284) CDS984355I, UDI-DI: 10195327569518(each), 40195327569519(case), Lot Number: 24BLA231; 285) CDS984355J, UDI-DI: 10198459096228(each), 40198459096229(case), Lot Number: 24LLA698; 286) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21FBE255; 287) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21BBS510; 288) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21ABE734; 289) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21LBP381; 290) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21JBZ656; 291) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21IBO615; 292) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21HBD158; 293) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23JBT159; 294) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23HBP383; 295) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23FBV374; 296) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23EBS635; 297) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23DBR889; 298) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23ABT277; 299) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22LBD272; 300) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22JBP078; 301) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22JBD236; 302) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22IBT102; 303) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22IBE901; 304) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22GBU933; 305) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22DBS062; 306) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22BBS888; 307) CDS985215C, UDI-DI: 10193489780109(each), 40193489780100(case), Lot Number: 21DBH711; 308) CVT159AA, UDI-DI: 10193489457513(each), 40193489457514(case), Lot Number: 22DBL279; 309) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24FBJ229; 310) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24DBF439; 311) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24BBT324; 312) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23JBP216; 313) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23IBI960; 314) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23GBI903; 315) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23EBO066; 316) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23DBT226; 317) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22LBD173; 318) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22KBA324; 319) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22IBA742; 320) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22GBL773; 321) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22EBS701; 322) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22BBI986; 323) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22BBF497; 324) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21KBI013; 325) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21IBQ531; 326) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21HBC943; 327) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21FBO379; 328) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBW789; 329) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBW788; 330) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBV599; 331) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBK912; 332) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21HBL002; 333) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21GBO480; 334) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21GBJ355; 335) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21FBO542; 336) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21FBF909; 337) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBN048; 338) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBC538; 339) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBA605; 340) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBS016; 341) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBO740; 342) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBM813; 343) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBF850; 344) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21BBN597; 345) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21ABO823; 346) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21ABI967; 347) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22HLA262; 348) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22FLB050; 349) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22FLA352; 350) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ELB070; 351) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ELA030; 352) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22DLA405; 353) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22CLA548; 354) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22BLB034; 355) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ALA723; 356) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ALA370; 357) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21KLA410; 358) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21HLB002; 359) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21GLA991; 360) DYKMBNDL", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide distribution - US Nationwide.", "Status": "recorded" } } ] } ] }