{ "@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-1884-2026.jsonld", "@type": "schema:Dataset", "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK\tDYNJ50783B \t ANGIO PHC\tDYNJ37485C\t \t C.I.C.N. ANGIO PACK\tDYNJ53064B \t FHT P NEURO PACK\tDYNJ39931D\t \t NEURO ARTERIOGRAM PACK-LF\tDYNJ0948060F\t \t NEURO KIT\tNAM0003 \t NEURO PACK\tDYNJ61542D \t NEURO RADIOLOGY PACK\tDYNJ59903B \t NEURO TRAY\tDYNJ84872A \t PK, CATH LAB-ANGIO\tDYNJ44027F \t QVH IR NEURO PACK\tDYNJ62176", "description": "FDA recall Z-1884-2026 — Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK\tDYNJ50783B \t ANGIO PHC\tDYNJ37485C\t \t C.I.C.N. ANGIO PACK\tDYNJ53064B \t FHT P NEURO PACK\tDYNJ39931D\t \t NEURO ARTERIOGRAM PACK-LF\tDYNJ0948060F\t \t NEURO KIT\tNAM0003 \t NEURO PACK\tDYNJ61542D \t NEURO RADIOLOGY PACK\tDYNJ59903B \t NEURO TRAY\tDYNJ84872A \t PK, CATH LAB-ANGIO\tDYNJ44027F \t QVH IR NEURO PACK\tDYNJ62176 (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-1884-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK\tDYNJ50783B \t ANGIO PHC\tDYNJ37485C\t \t C.I.C.N. ANGIO PACK\tDYNJ53064B \t FHT P NEURO PACK\tDYNJ39931D\t \t NEURO ARTERIOGRAM PACK-LF\tDYNJ0948060F\t \t NEURO KIT\tNAM0003 \t NEURO PACK\tDYNJ61542D \t NEURO RADIOLOGY PACK\tDYNJ59903B \t NEURO TRAY\tDYNJ84872A \t PK, CATH LAB-ANGIO\tDYNJ44027F \t QVH IR NEURO PACK\tDYNJ62176", "manufacturer": { "@type": "schema:Organization", "name": "Medline Industries, LP" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1884-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1884-2026: Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK\tDYNJ50783B \t ANGIO PHC\tDYNJ37485C\t \t C.I.C.N. ANGIO PACK\tDYNJ53064B \t FHT P NEURO PACK\tDYNJ39931D\t \t NEURO ARTERIOGRAM PACK-LF\tDYNJ0948060F\t \t NEURO KIT\tNAM0003 \t NEURO PACK\tDYNJ61542D \t NEURO RADIOLOGY PACK\tDYNJ59903B \t NEURO TRAY\tDYNJ84872A \t PK, CATH LAB-ANGIO\tDYNJ44027F \t QVH IR NEURO PACK\tDYNJ62176", "text": "The FDA logged enforcement record Z-1884-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK\tDYNJ50783B \t ANGIO PHC\tDYNJ37485C\t \t C.I.C.N. ANGIO PACK\tDYNJ53064B \t FHT P NEURO PACK\tDYNJ39931D\t \t NEURO ARTERIOGRAM PACK-LF\tDYNJ0948060F\t \t NEURO KIT\tNAM0003 \t NEURO PACK\tDYNJ61542D \t NEURO RADIOLOGY PACK\tDYNJ59903B \t NEURO TRAY\tDYNJ84872A \t PK, CATH LAB-ANGIO\tDYNJ44027F \t QVH IR NEURO PACK\tDYNJ62176 — reason: Unapproved design changes to the products outside of the 510(k) clearance.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-02-27. Affected lots/codes: DYNJ50783B UDI-DI 10193489227376 (EA) 40193489227377 (CS) LOT 23FBF183 DYNJ37485C UDI-DI 10193489760002 (EA) 40193489760003 (CS) LOTS 20BBX692 20DBC089 20EBG816 20FBR153 20HBN288 20IBK578 20KBW291 21BBB266 21CBW198 21FBH674 21GBS840 21GBS842 21JBU703 21LBX721 22BBV337 22EBN708 22IBJ467 22JBH996 22KBU901 22OBJ150 23ABG615 23BBF603 23CBC306 DYNJ53064B UDI-DI 10193489789164 (EA) 40193489789165 (CS) LOT 23HMI416 DYNJ39931D UDI-DI 10193489459364 (EA) 40193489459365 (CS) LOTS 23BBB182 23DBK363 24HBJ427 24JBI915 24JBV985 24KBH817 25GBI670 25IBS445 DYNJ0948060F UDI-DI 10889942825103 (EA) 40889942825104 (CS) LOTS 23FMA240 24EBR693 24GLB224 24HLA705 24JLA904 NAM0003 UDI-DI 10193489222555 (EA) 40193489222556 (CS) LOTS 20DBO375 20GBC317 20GBJ719 20HBC159 20HBD815 20HBF519 20IBA514 23CMC981 23DMC490 23DMF161 23GMA353 23HME057 23HMG264 23IMF173 23JMF878 23JMH829 23KME885 23LMA780 23LMD088 23LMG059 24AMF167 24AMH128 24EMG747 24HMJ041 24JMC680 DYNJ61542D UDI-DI 10195327507923 (EA) 40195327507924 (CS) LOT 24FMC929 DYNJ59903B UDI-DI 10195327131203 (EA) 40195327131204 (CS) LOTS 23EBQ216 23HBC089 23IBE176 23KBL439 23LBO494 24ABL938 24CBQ708 24EBB108 24FBA584 24FBN897 24JBC983 24JBO349 24KBB061 24KBT242 24LBP491 DYNJ84872A UDI-DI 10195327481506 (EA) 40195327481507 (CS) LOTS 23LBN462 24ABC179 DYNJ44027F UDI-DI 10193489783490 (EA) 40193489783491 (CS) LOTS 21FLA184 21FLA910 21ILA783 21JLA542 21LLA177 22ALA731 22BLA802 22DLA497 22ELA818 22FLA432 22GLB161 22HLB062 22JBC795 22JBM045 22KBO209 22KBO210 23DBR512 23FBQ563 23GBK955 23HBY707 23JBT738 23KBF311 23KBU563 24ABW467 24GBK560 24HBB843 24IBI798 24IBR643 24JBF292 DYNJ62176 UDI-DI 10193489631784 (EA) 40193489631785 (CS) LOTS 23ELA677 23GLA263 23KLB156 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ0948060F lots 21AMA919 21AMB491 21BMC178 21HMF800 21JMG472 22AMB406 22CMI927 22EMC824 22GMF261 22IMA651 22JMG952 22KME549 22LMD531 23AMD745 23AMJ626 23CMB808 23DMC060 23EMB613 23EMG672 23GMG693 23GMI438 23IMG055 23KBR802 24ABP567 25ALA622 25ALA678 25CLA317 25DLA949 25ELA692; DYNJ39931D lots 21ABW861 21CBY118 21DBN140 21HBN105 21KBO171 21LBP808 21LBP811 22CBY154 22FBA263 22JBU799 23BBR777 23BBT177 23EBS918 23FBO983 23GBR315 23GBW410 23HBJ976 23IBJ863 23KBC962 23LBU944 24ABK323 24ABP442 24BBH773 24GBO821; DYNJ44027F lots 21BLA158 21CLA034 21DLA700 25EBE984 25EBU842; DYNJ50783B lots 21DBL972 21FBK452 21GBA227 21IBA354 21JBO239 21KBP327 21LBB845 21LBU425 22DBC322 22DBN517 22EBK090 22FBK172 22HBU114 22KBQ551 22KBQ552 23BBJ725 23CBO941 23EBC283; DYNJ59903B lots 22EBI499 22FBF028 22FBR425 22IBJ538 22LBQ311 23ABN466 23CBJ596 23CBP099 25DBF626; DYNJ62176 lots 21ALA437 21BLA178 21BLA238 21BLA352 21CLA516 21GLB100 22ALA163 22BLB207 22ELB041 22KLA092 22LLA728 23ALA743 23BLA184 23KLB124 24BLA180 24ELA039 24JLA075; DYNJ84872A lots 23IBS046; NAM0003 lots 21BBF218 21CBE230 21DBV018 21EBS508 21GBI653 21KBO486 21LBB470 22CME110 22EMH496 25AMG212 25BMA481 25BMF357 25BMH684 25DMH014 25DMH503 25EMD617 25EMI879. 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-1884-2026&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-1884-2026&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-1884-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1884-2026 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-1884-2026&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-1884-2026&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-1884-2026/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-1884-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1884-2026", "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": "Unapproved design changes to the products outside of the 510(k) clearance.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2026-02-27", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "DYNJ50783B UDI-DI 10193489227376 (EA) 40193489227377 (CS) LOT 23FBF183 DYNJ37485C UDI-DI 10193489760002 (EA) 40193489760003 (CS) LOTS 20BBX692 20DBC089 20EBG816 20FBR153 20HBN288 20IBK578 20KBW291 21BBB266 21CBW198 21FBH674 21GBS840 21GBS842 21JBU703 21LBX721 22BBV337 22EBN708 22IBJ467 22JBH996 22KBU901 22OBJ150 23ABG615 23BBF603 23CBC306 DYNJ53064B UDI-DI 10193489789164 (EA) 40193489789165 (CS) LOT 23HMI416 DYNJ39931D UDI-DI 10193489459364 (EA) 40193489459365 (CS) LOTS 23BBB182 23DBK363 24HBJ427 24JBI915 24JBV985 24KBH817 25GBI670 25IBS445 DYNJ0948060F UDI-DI 10889942825103 (EA) 40889942825104 (CS) LOTS 23FMA240 24EBR693 24GLB224 24HLA705 24JLA904 NAM0003 UDI-DI 10193489222555 (EA) 40193489222556 (CS) LOTS 20DBO375 20GBC317 20GBJ719 20HBC159 20HBD815 20HBF519 20IBA514 23CMC981 23DMC490 23DMF161 23GMA353 23HME057 23HMG264 23IMF173 23JMF878 23JMH829 23KME885 23LMA780 23LMD088 23LMG059 24AMF167 24AMH128 24EMG747 24HMJ041 24JMC680 DYNJ61542D UDI-DI 10195327507923 (EA) 40195327507924 (CS) LOT 24FMC929 DYNJ59903B UDI-DI 10195327131203 (EA) 40195327131204 (CS) LOTS 23EBQ216 23HBC089 23IBE176 23KBL439 23LBO494 24ABL938 24CBQ708 24EBB108 24FBA584 24FBN897 24JBC983 24JBO349 24KBB061 24KBT242 24LBP491 DYNJ84872A UDI-DI 10195327481506 (EA) 40195327481507 (CS) LOTS 23LBN462 24ABC179 DYNJ44027F UDI-DI 10193489783490 (EA) 40193489783491 (CS) LOTS 21FLA184 21FLA910 21ILA783 21JLA542 21LLA177 22ALA731 22BLA802 22DLA497 22ELA818 22FLA432 22GLB161 22HLB062 22JBC795 22JBM045 22KBO209 22KBO210 23DBR512 23FBQ563 23GBK955 23HBY707 23JBT738 23KBF311 23KBU563 24ABW467 24GBK560 24HBB843 24IBI798 24IBR643 24JBF292 DYNJ62176 UDI-DI 10193489631784 (EA) 40193489631785 (CS) LOTS 23ELA677 23GLA263 23KLB156 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ0948060F lots 21AMA919 21AMB491 21BMC178 21HMF800 21JMG472 22AMB406 22CMI927 22EMC824 22GMF261 22IMA651 22JMG952 22KME549 22LMD531 23AMD745 23AMJ626 23CMB808 23DMC060 23EMB613 23EMG672 23GMG693 23GMI438 23IMG055 23KBR802 24ABP567 25ALA622 25ALA678 25CLA317 25DLA949 25ELA692; DYNJ39931D lots 21ABW861 21CBY118 21DBN140 21HBN105 21KBO171 21LBP808 21LBP811 22CBY154 22FBA263 22JBU799 23BBR777 23BBT177 23EBS918 23FBO983 23GBR315 23GBW410 23HBJ976 23IBJ863 23KBC962 23LBU944 24ABK323 24ABP442 24BBH773 24GBO821; DYNJ44027F lots 21BLA158 21CLA034 21DLA700 25EBE984 25EBU842; DYNJ50783B lots 21DBL972 21FBK452 21GBA227 21IBA354 21JBO239 21KBP327 21LBB845 21LBU425 22DBC322 22DBN517 22EBK090 22FBK172 22HBU114 22KBQ551 22KBQ552 23BBJ725 23CBO941 23EBC283; DYNJ59903B lots 22EBI499 22FBF028 22FBR425 22IBJ538 22LBQ311 23ABN466 23CBJ596 23CBP099 25DBF626; DYNJ62176 lots 21ALA437 21BLA178 21BLA238 21BLA352 21CLA516 21GLB100 22ALA163 22BLB207 22ELB041 22KLA092 22LLA728 23ALA743 23BLA184 23KLB124 24BLA180 24ELA039 24JLA075; DYNJ84872A lots 23IBS046; NAM0003 lots 21BBF218 21CBE230 21DBV018 21EBS508 21GBI653 21KBO486 21LBB470 22CME110 22EMH496 25AMG212 25BMA481 25BMF357 25BMH684 25DMH014 25DMH503 25EMD617 25EMI879", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.", "Status": "recorded" } } ] } ] }