{
  "@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",
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    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
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    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1419-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience Kits:  1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N;   2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K;   3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O;   4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A;   5) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A;   6) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G;   7) ROBOTIC PACK, Model Number: DYNJ04135B;   8) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J;   9) NBMC D & C PACK-LF, Model Number: DYNJ0665843C;   10) D&C PACK-LF, Model Number: DYNJ22567G;   11) D&C PACK-LF, Model Number: DYNJ22567J;   12) D AND C, Model Number: DYNJ41272B;   13) D AND C, Model Number: DYNJ41272C;   14) OB PACK, Model Number: DYNJ42884;   15) D&C/GYN PACK, Model Number: DYNJ47713A;   16) PERI GYN PACK, Model Number: DYNJ55377D;   17) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344;   18) D&C PACK, Model Number: DYNJ67214D;   19) D&C PACK, Model Number: DYNJ67214F;   20) D&C PACK, Model Number: DYNJ67214G;   21) D&C PACK, Model Number: DYNJ67214I;   22) LITHOTOMY PACK, Model Number: DYNJ80765C;   23) GYN PACK, Model Number: DYNJ83475;   24) D AND C PACK, Model Number: DYNJ87468;   25) D&C-ASC, Model Number: DYNJ900465C;   26) D&C-ASC, Model Number: DYNJ900465D;   27) D&C-ASC, Model Number: DYNJ900465F;   28) GYN LITHOTOMY-LF, Model Number: DYNJ902711L;   29) GYN LITHOTOMY-LF, Model Number: DYNJ902711N;   30) D&C, Model Number: DYNJ906947C;   31) PACK PERI GYN DSMC, Model Number: DYNJT6424",
  "description": "FDA recall Z-1419-2026 — Medline Industries, LP is recalling Medline Convenience Kits:  1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N;   2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K;   3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O;   4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A;   5) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A;   6) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G;   7) ROBOTIC PACK, Model Number: DYNJ04135B;   8) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J;   9) NBMC D & C PACK-LF, Model Number: DYNJ0665843C;   10) D&C PACK-LF, Model Number: DYNJ22567G;   11) D&C PACK-LF, Model Number: DYNJ22567J;   12) D AND C, Model Number: DYNJ41272B;   13) D AND C, Model Number: DYNJ41272C;   14) OB PACK, Model Number: DYNJ42884;   15) D&C/GYN PACK, Model Number: DYNJ47713A;   16) PERI GYN PACK, Model Number: DYNJ55377D;   17) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344;   18) D&C PACK, Model Number: DYNJ67214D;   19) D&C PACK, Model Number: DYNJ67214F;   20) D&C PACK, Model Number: DYNJ67214G;   21) D&C PACK, Model Number: DYNJ67214I;   22) LITHOTOMY PACK, Model Number: DYNJ80765C;   23) GYN PACK, Model Number: DYNJ83475;   24) D AND C PACK, Model Number: DYNJ87468;   25) D&C-ASC, Model Number: DYNJ900465C;   26) D&C-ASC, Model Number: DYNJ900465D;   27) D&C-ASC, Model Number: DYNJ900465F;   28) GYN LITHOTOMY-LF, Model Number: DYNJ902711L;   29) GYN LITHOTOMY-LF, Model Number: DYNJ902711N;   30) D&C, Model Number: DYNJ906947C;   31) PACK PERI GYN DSMC, Model Number: DYNJT6424 (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-1419-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience Kits:  1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N;   2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K;   3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O;   4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A;   5) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A;   6) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G;   7) ROBOTIC PACK, Model Number: DYNJ04135B;   8) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J;   9) NBMC D & C PACK-LF, Model Number: DYNJ0665843C;   10) D&C PACK-LF, Model Number: DYNJ22567G;   11) D&C PACK-LF, Model Number: DYNJ22567J;   12) D AND C, Model Number: DYNJ41272B;   13) D AND C, Model Number: DYNJ41272C;   14) OB PACK, Model Number: DYNJ42884;   15) D&C/GYN PACK, Model Number: DYNJ47713A;   16) PERI GYN PACK, Model Number: DYNJ55377D;   17) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344;   18) D&C PACK, Model Number: DYNJ67214D;   19) D&C PACK, Model Number: DYNJ67214F;   20) D&C PACK, Model Number: DYNJ67214G;   21) D&C PACK, Model Number: DYNJ67214I;   22) LITHOTOMY PACK, Model Number: DYNJ80765C;   23) GYN PACK, Model Number: DYNJ83475;   24) D AND C PACK, Model Number: DYNJ87468;   25) D&C-ASC, Model Number: DYNJ900465C;   26) D&C-ASC, Model Number: DYNJ900465D;   27) D&C-ASC, Model Number: DYNJ900465F;   28) GYN LITHOTOMY-LF, Model Number: DYNJ902711L;   29) GYN LITHOTOMY-LF, Model Number: DYNJ902711N;   30) D&C, Model Number: DYNJ906947C;   31) PACK PERI GYN DSMC, Model Number: DYNJT6424",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1419-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1419-2026: Medline Industries, LP is recalling Medline Convenience Kits:  1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N;   2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K;   3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O;   4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A;   5) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A;   6) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G;   7) ROBOTIC PACK, Model Number: DYNJ04135B;   8) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J;   9) NBMC D & C PACK-LF, Model Number: DYNJ0665843C;   10) D&C PACK-LF, Model Number: DYNJ22567G;   11) D&C PACK-LF, Model Number: DYNJ22567J;   12) D AND C, Model Number: DYNJ41272B;   13) D AND C, Model Number: DYNJ41272C;   14) OB PACK, Model Number: DYNJ42884;   15) D&C/GYN PACK, Model Number: DYNJ47713A;   16) PERI GYN PACK, Model Number: DYNJ55377D;   17) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344;   18) D&C PACK, Model Number: DYNJ67214D;   19) D&C PACK, Model Number: DYNJ67214F;   20) D&C PACK, Model Number: DYNJ67214G;   21) D&C PACK, Model Number: DYNJ67214I;   22) LITHOTOMY PACK, Model Number: DYNJ80765C;   23) GYN PACK, Model Number: DYNJ83475;   24) D AND C PACK, Model Number: DYNJ87468;   25) D&C-ASC, Model Number: DYNJ900465C;   26) D&C-ASC, Model Number: DYNJ900465D;   27) D&C-ASC, Model Number: DYNJ900465F;   28) GYN LITHOTOMY-LF, Model Number: DYNJ902711L;   29) GYN LITHOTOMY-LF, Model Number: DYNJ902711N;   30) D&C, Model Number: DYNJ906947C;   31) PACK PERI GYN DSMC, Model Number: DYNJT6424",
      "text": "The FDA logged enforcement record Z-1419-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits:  1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N;   2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K;   3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O;   4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A;   5) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A;   6) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G;   7) ROBOTIC PACK, Model Number: DYNJ04135B;   8) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J;   9) NBMC D & C PACK-LF, Model Number: DYNJ0665843C;   10) D&C PACK-LF, Model Number: DYNJ22567G;   11) D&C PACK-LF, Model Number: DYNJ22567J;   12) D AND C, Model Number: DYNJ41272B;   13) D AND C, Model Number: DYNJ41272C;   14) OB PACK, Model Number: DYNJ42884;   15) D&C/GYN PACK, Model Number: DYNJ47713A;   16) PERI GYN PACK, Model Number: DYNJ55377D;   17) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344;   18) D&C PACK, Model Number: DYNJ67214D;   19) D&C PACK, Model Number: DYNJ67214F;   20) D&C PACK, Model Number: DYNJ67214G;   21) D&C PACK, Model Number: DYNJ67214I;   22) LITHOTOMY PACK, Model Number: DYNJ80765C;   23) GYN PACK, Model Number: DYNJ83475;   24) D AND C PACK, Model Number: DYNJ87468;   25) D&C-ASC, Model Number: DYNJ900465C;   26) D&C-ASC, Model Number: DYNJ900465D;   27) D&C-ASC, Model Number: DYNJ900465F;   28) GYN LITHOTOMY-LF, Model Number: DYNJ902711L;   29) GYN LITHOTOMY-LF, Model Number: DYNJ902711N;   30) D&C, Model Number: DYNJ906947C;   31) PACK PERI GYN DSMC, Model Number: DYNJT6424 — 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) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21DBO201; 2) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21CBD150; 3) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBM332; 4) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBL932; 5) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25GBB847; 6) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21IBS290; 7) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21GBE967; 8) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21FBB105; 9) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21DBC065; 10) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21CBQ508; 11) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22HBE127; 12) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22GBL821; 13) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBM235; 14) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBC878; 15) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP063; 16) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP060; 17) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21KBQ697; 18) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21HBB549; 19) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21FBB101; 20) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21DBE919; 21) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25GBG086; 22) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25EBM426; 23) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25BBI842; 24) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25ABF361; 25) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBH410; 26) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBE008; 27) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24KBD429; 28) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBH005; 29) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23CBK988; 30) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 20XBF598; 31) DYNJ04382J, UDI-DI: 10195327271763(each), 40195327271764(case), Lot Number: 22JMI206; 32) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 23LBR468; 33) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 23JBL141; 34) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21DBJ206; 35) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21ABL629; 36) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21ABK140; 37) DYNJ22567J, UDI-DI: 10195327524876(each), 40195327524877(case), Lot Number: 24FBJ094; 38) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23GMF146; 39) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23EME955; 40) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23AMG245; 41) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23AMG044; 42) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22GME486; 43) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22DMD888; 44) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22AME935; 45) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21LMB348; 46) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21IMB245; 47) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21GMF389; 48) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21FMA773; 49) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21DME541; 50) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21BMB150; 51) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21AMA560; 52) DYNJ41272C, UDI-DI: 10195327487409(each), 40195327487400(case), Lot Number: 23IMA347; 53) DYNJ42884, UDI-DI: 10888277011076(each), 40888277011077(case), Lot Number: 23CBJ945; 54) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24GBW285; 55) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24FBB582; 56) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24DBG903; 57) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23IBQ206; 58) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23GBP395; 59) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23FBV760; 60) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23FBQ343; 61) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23EBB329; 62) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23DBC104; 63) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23CBB298; 64) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23ABU921; 65) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22KBF536; 66) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22JBM589; 67) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22DBQ586; 68) DYNJ58344, UDI-DI: 10889942841721(each), 40889942841722(case), Lot Number: 21DBG514; 69) DYNJ67214D, UDI-DI: 10195327133320(each), 40195327133321(case), Lot Number: 22JBM637; 70) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 23CBS078; 71) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 23BBM551; 72) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 22LBT250; 73) DYNJ67214G, UDI-DI: 10195327411305(each), 40195327411306(case), Lot Number: 23LBG081; 74) DYNJ67214G, UDI-DI: 10195327411305(each), 40195327411306(case), Lot Number: 23GBI555; 75) DYNJ67214I, UDI-DI: 10195327586959(each), 40195327586950(case), Lot Number: 24DBB420; 76) DYNJ67214I, UDI-DI: 10195327586959(each), 40195327586950(case), Lot Number: 24ABG486; 77) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25LBI656; 78) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25KBT912; 79) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25IBL938; 80) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25IBC889; 81) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25GBO543; 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105) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 23KMA629; 106) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 23JMD404; 107) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25LMA690; 108) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25IMG392; 109) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25BMF779; 110) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 24IMI010; 111) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24LBF949; 112) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24KBT705; 113) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24JBH803; 114) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24HBU990; 115) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24GBW026; 116) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24EBJ699; 117) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24DBI465; 118) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24CBT820; 119) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24BBG800; 120) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24BBC557; 121) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24ABG736; 122) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23LBP758; 123) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23KBN910; 124) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23KBH145; 125) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23IBA468; 126) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23HBI647; 127) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25LMF580; 128) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25JBO532; 129) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25IBD839; 130) DYNJ906947C, UDI-DI: 10195327569006(each), 40195327569007(case), Lot Number: 24BBL769; 131) DYNJT6424, UDI-DI: 10198459553622(each), 40198459553623(case), Lot Number: 25KMI469. 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-1419-2026&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-1419-2026&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-1419-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1419-2026 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-1419-2026&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-1419-2026&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-1419-2026/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": [
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      "name": "FDA recall details — Z-1419-2026",
      "numberOfItems": 9,
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        {
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1419-2026",
            "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"
          }
        },
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46) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21IMB245; 47) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21GMF389; 48) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21FMA773; 49) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21DME541; 50) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21BMB150; 51) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21AMA560; 52) DYNJ41272C, UDI-DI: 10195327487409(each), 40195327487400(case), Lot Number: 23IMA347; 53) DYNJ42884, UDI-DI: 10888277011076(each), 40888277011077(case), Lot Number: 23CBJ945; 54) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24GBW285; 55) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24FBB582; 56) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24DBG903; 57) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23IBQ206; 58) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23GBP395; 59) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23FBV760; 60) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23FBQ343; 61) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23EBB329; 62) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23DBC104; 63) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23CBB298; 64) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23ABU921; 65) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22KBF536; 66) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22JBM589; 67) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22DBQ586; 68) DYNJ58344, UDI-DI: 10889942841721(each), 40889942841722(case), Lot Number: 21DBG514; 69) DYNJ67214D, UDI-DI: 10195327133320(each), 40195327133321(case), Lot Number: 22JBM637; 70) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 23CBS078; 71) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 23BBM551; 72) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 22LBT250; 73) DYNJ67214G, UDI-DI: 10195327411305(each), 40195327411306(case), Lot Number: 23LBG081; 74) DYNJ67214G, UDI-DI: 10195327411305(each), 40195327411306(case), Lot Number: 23GBI555; 75) DYNJ67214I, UDI-DI: 10195327586959(each), 40195327586950(case), Lot Number: 24DBB420; 76) DYNJ67214I, UDI-DI: 10195327586959(each), 40195327586950(case), Lot Number: 24ABG486; 77) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25LBI656; 78) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25KBT912; 79) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25IBL938; 80) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25IBC889; 81) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25GBO543; 82) DYNJ83475, UDI-DI: 10195327268411(each), 40195327268412(case), Lot Number: 23GBA918; 83) DYNJ87468, UDI-DI: 10198459041266(each), 40198459041267(case), Lot Number: 24HBC480; 84) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23FMD008; 85) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23DME071; 86) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23DMC062; 87) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23AMJ541; 88) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22JMF456; 89) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22IMC505; 90) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22IMA128; 91) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22GBP729; 92) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22EBG597; 93) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22EBD247; 94) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22BBE872; 95) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21JBW028; 96) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21IBI550; 97) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21IBA045; 98) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21HBK281; 99) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21FBL088; 100) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21DBC055; 101) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21ABU698; 102) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24EMG501; 103) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24CME409; 104) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24AMA976; 105) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 23KMA629; 106) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 23JMD404; 107) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25LMA690; 108) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25IMG392; 109) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25BMF779; 110) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 24IMI010; 111) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24LBF949; 112) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24KBT705; 113) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24JBH803; 114) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24HBU990; 115) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24GBW026; 116) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24EBJ699; 117) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24DBI465; 118) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24CBT820; 119) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24BBG800; 120) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24BBC557; 121) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24ABG736; 122) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23LBP758; 123) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23KBN910; 124) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23KBH145; 125) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23IBA468; 126) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23HBI647; 127) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25LMF580; 128) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25JBO532; 129) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25IBD839; 130) DYNJ906947C, UDI-DI: 10195327569006(each), 40195327569007(case), Lot Number: 24BBL769; 131) DYNJT6424, UDI-DI: 10198459553622(each), 40198459553623(case), Lot Number: 25KMI469",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}