{ "@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-1876-2026.jsonld", "@type": "schema:Dataset", "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK\tDYNJ32555C, DYNJ66631 \t ANGIO TRAY\tDYNJ46153B \t ANGIOGRAPHY PACK\tDYNJ26855F \t ANGIOGRAPHY PACK-M-LF\tDYNJ24530I \t ANGIOGRAPHY TRAY-LF\tDYNJ0220880V, DYNJ30077D \t CATH LAB ANGIO PACK-LF\tDYNJ0545064X \t CATH LAB PACK\tDYNJ39057C \t FEMORAL ANGIOGRAPY SET UP\tDYNJ61015B \t RAD-ANGIO PACK\tDYNJ47710C \t SURGERY ANGIO PACK-LF\tPHS677784013A", "description": "FDA recall Z-1876-2026 — Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK\tDYNJ32555C, DYNJ66631 \t ANGIO TRAY\tDYNJ46153B \t ANGIOGRAPHY PACK\tDYNJ26855F \t ANGIOGRAPHY PACK-M-LF\tDYNJ24530I \t ANGIOGRAPHY TRAY-LF\tDYNJ0220880V, DYNJ30077D \t CATH LAB ANGIO PACK-LF\tDYNJ0545064X \t CATH LAB PACK\tDYNJ39057C \t FEMORAL ANGIOGRAPY SET UP\tDYNJ61015B \t RAD-ANGIO PACK\tDYNJ47710C \t SURGERY ANGIO PACK-LF\tPHS677784013A (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-1876-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK\tDYNJ32555C, DYNJ66631 \t ANGIO TRAY\tDYNJ46153B \t ANGIOGRAPHY PACK\tDYNJ26855F \t ANGIOGRAPHY PACK-M-LF\tDYNJ24530I \t ANGIOGRAPHY TRAY-LF\tDYNJ0220880V, DYNJ30077D \t CATH LAB ANGIO PACK-LF\tDYNJ0545064X \t CATH LAB PACK\tDYNJ39057C \t FEMORAL ANGIOGRAPY SET UP\tDYNJ61015B \t RAD-ANGIO PACK\tDYNJ47710C \t SURGERY ANGIO PACK-LF\tPHS677784013A", "manufacturer": { "@type": "schema:Organization", "name": "Medline Industries, LP" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1876-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1876-2026: Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK\tDYNJ32555C, DYNJ66631 \t ANGIO TRAY\tDYNJ46153B \t ANGIOGRAPHY PACK\tDYNJ26855F \t ANGIOGRAPHY PACK-M-LF\tDYNJ24530I \t ANGIOGRAPHY TRAY-LF\tDYNJ0220880V, DYNJ30077D \t CATH LAB ANGIO PACK-LF\tDYNJ0545064X \t CATH LAB PACK\tDYNJ39057C \t FEMORAL ANGIOGRAPY SET UP\tDYNJ61015B \t RAD-ANGIO PACK\tDYNJ47710C \t SURGERY ANGIO PACK-LF\tPHS677784013A", "text": "The FDA logged enforcement record Z-1876-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK\tDYNJ32555C, DYNJ66631 \t ANGIO TRAY\tDYNJ46153B \t ANGIOGRAPHY PACK\tDYNJ26855F \t ANGIOGRAPHY PACK-M-LF\tDYNJ24530I \t ANGIOGRAPHY TRAY-LF\tDYNJ0220880V, DYNJ30077D \t CATH LAB ANGIO PACK-LF\tDYNJ0545064X \t CATH LAB PACK\tDYNJ39057C \t FEMORAL ANGIOGRAPY SET UP\tDYNJ61015B \t RAD-ANGIO PACK\tDYNJ47710C \t SURGERY ANGIO PACK-LF\tPHS677784013A — 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: DYNJ51126 UDI-DI 10889942122820 (EA) 40889942122821 (CS) LOT 20ADA585 DYNJ32555C UDI-DI 10193489859485 (EA) 40193489859486 (CS) LOTS 21HMF699 21IMF813 21JMA855 21KMD605 22DMB423 22FMD574 22HMB608 22LMA169 23BMA114 23EMB817 23EMG153 23KMB692 23KMH359 23LMH085 24AMC563 24CMD587 24DMD256 24DMG305 24FMD717 24IMI650 24JMC830 DYNJ66631 UDI-DI 10193489368321 (EA) 40193489368322 (CS) LOTS 22BBB494 22BBB497 DYNJ46153B UDI-DI 10193489853643 (EA) 40193489853644 (CS) LOTS 23EBM225 23FBC884 23HBP278 23IBV999 23KBC319 23LBK125 24CBF100 24DBE952 24FBP262 24GBN960 24HBO921 24IBO007 24IBU941 24JBK669 24LBK644 DYNJ26855F UDI-DI 10888277012042 (EA) 40888277012043 (CS) LOTS 20CBI049 20EBB600 20FBK900 20GBD331 20GBL795 20IBC788 20JBM786 20KBF148 21BBK244 21EBR327 21HBB849 21IBQ809 21OBA396 DYNJ24530I UDI- DI 10193489674910 (EA) 40193489674911 (CS) LOT 24ABU775 DYNJ0220880V UDI-DI 10889942054688 (EA) 40889942054689 (CS) LOTS 23HLA505 23HLB257 23JLA021 23JLA059 23KLA121 23KLA231 23KLA582 23LLA817 24ELA405 24ELA796 24HLA596 25AMI609 25BMH660 25CMA797 25DMF893 DYNJ30077D UDI-DI 10889942138630 (EA) 40889942138631 (CS) LOTS 23FBQ479 23LBL707 24CBC495 24EBQ346 24GBK895 24HBD023 24HBP290 24JBJ112 DYNJ0545064X UDI-DI 10193489747621 (EA) 40193489747622 (CS) LOTS 20BBL115 20CBA649 20DBB933 20DBP595 20HBW939 20KBI815 21ABK039 21ABK542 DYNJ39057C UDI-DI 10193489765519 (EA) 40193489765510 (CS) LOT 24BBD166 DYNJ61015B UDI-DI 10193489368888 (EA) 40193489368889 (CS) LOTS 23CMG023 23FBN151 DYNJ47710C UDI-DI 10889942214495 (EA) 40889942214496 (CS) LOTS 23FBF109 23GBB677 23JBP270 23LBO688 24DBD356 24FBP326 24IBC340 24KBJ788 PHS677784013A UDI-DI 10193489604337 (EA) 40193489604338 (CS) LOTS 20BBR301 20IMA683 21BMC467 21CMC052 21FMD140 21IMF229 22AMA959 22AME458 23GMA491 23GMD585 ***Updated 5/20/26 - The following lots were included in the customer notification but not in the FDA submission.*** DYNJ0220880V Lots 21DLA453 21FLA083 21ILA147 21KLA059 22ALA849 22DLA707 22FLA700 22HLA272 22ILA188 22ILA237 22ILA641 22JLA662 22KLA836 22KLA939 22LLA399 25KMB595 25LMA384; DYNJ30077D Lots 21ABB348 21ABR327 21DBQ397 21FBM873 21GBL539 21IBB390 21JBO220 21KBC302 21KBV079 21LBT528 22ABZ834 22DBD744 22EBG375 22JBK533 22KBO291 22OBM411 23ABD824 23ABO419 23DBB788 23EBS951 23HBB563 23IBG762 23JBT149 24CBR583; DYNJ32555C Lots 21DMA301 21DMD929 21EMB686 21FMA163 22KMD644 23AMB073 24LMH114 25BMA103 25BMD349; DYNJ46153B Lots 21CBL359 21FBE618 21GBF346 21HBQ716 21IBW154 21KBI853 21LBA401 22ABE877 22BBW978 22CBU323 22EBN725 22FBQ420 22GBJ229 22HBD581 22IBL258 22JBM061 22KBD440 22NBA199 23ABG769 23BBE724 25BBR850 25EBA187; DYNJ47710C Lots 21CBM120 21GBL622 21KBA849 21KBA925 22ABX239 22CBP654 22JBI023 22LBR933 23BBT611 25BBF414 25CBJ501; DYNJ61015B Lots 21AMB131 21BMB923 21BMC128 21CMD384 21DMD441 21FMD102 21GME205 21JMG652 22AMD050 22AME244 22DME869 22FMA872 22FMD246 22GMG534 22IMB779 22IMF574 22JMG963 23AMD815 23BMB886 23DMC707; DYNJ66631 Lots 21IBH359 21VBC892 22BBW852 22DBJ281 22EBJ532 22GBA380. 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-1876-2026&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-1876-2026&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-1876-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1876-2026 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-1876-2026&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-1876-2026&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-1876-2026/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-1876-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1876-2026", "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": "DYNJ51126 UDI-DI 10889942122820 (EA) 40889942122821 (CS) LOT 20ADA585 DYNJ32555C UDI-DI 10193489859485 (EA) 40193489859486 (CS) LOTS 21HMF699 21IMF813 21JMA855 21KMD605 22DMB423 22FMD574 22HMB608 22LMA169 23BMA114 23EMB817 23EMG153 23KMB692 23KMH359 23LMH085 24AMC563 24CMD587 24DMD256 24DMG305 24FMD717 24IMI650 24JMC830 DYNJ66631 UDI-DI 10193489368321 (EA) 40193489368322 (CS) LOTS 22BBB494 22BBB497 DYNJ46153B UDI-DI 10193489853643 (EA) 40193489853644 (CS) LOTS 23EBM225 23FBC884 23HBP278 23IBV999 23KBC319 23LBK125 24CBF100 24DBE952 24FBP262 24GBN960 24HBO921 24IBO007 24IBU941 24JBK669 24LBK644 DYNJ26855F UDI-DI 10888277012042 (EA) 40888277012043 (CS) LOTS 20CBI049 20EBB600 20FBK900 20GBD331 20GBL795 20IBC788 20JBM786 20KBF148 21BBK244 21EBR327 21HBB849 21IBQ809 21OBA396 DYNJ24530I UDI- DI 10193489674910 (EA) 40193489674911 (CS) LOT 24ABU775 DYNJ0220880V UDI-DI 10889942054688 (EA) 40889942054689 (CS) LOTS 23HLA505 23HLB257 23JLA021 23JLA059 23KLA121 23KLA231 23KLA582 23LLA817 24ELA405 24ELA796 24HLA596 25AMI609 25BMH660 25CMA797 25DMF893 DYNJ30077D UDI-DI 10889942138630 (EA) 40889942138631 (CS) LOTS 23FBQ479 23LBL707 24CBC495 24EBQ346 24GBK895 24HBD023 24HBP290 24JBJ112 DYNJ0545064X UDI-DI 10193489747621 (EA) 40193489747622 (CS) LOTS 20BBL115 20CBA649 20DBB933 20DBP595 20HBW939 20KBI815 21ABK039 21ABK542 DYNJ39057C UDI-DI 10193489765519 (EA) 40193489765510 (CS) LOT 24BBD166 DYNJ61015B UDI-DI 10193489368888 (EA) 40193489368889 (CS) LOTS 23CMG023 23FBN151 DYNJ47710C UDI-DI 10889942214495 (EA) 40889942214496 (CS) LOTS 23FBF109 23GBB677 23JBP270 23LBO688 24DBD356 24FBP326 24IBC340 24KBJ788 PHS677784013A UDI-DI 10193489604337 (EA) 40193489604338 (CS) LOTS 20BBR301 20IMA683 21BMC467 21CMC052 21FMD140 21IMF229 22AMA959 22AME458 23GMA491 23GMD585 ***Updated 5/20/26 - The following lots were included in the customer notification but not in the FDA submission.*** DYNJ0220880V Lots 21DLA453 21FLA083 21ILA147 21KLA059 22ALA849 22DLA707 22FLA700 22HLA272 22ILA188 22ILA237 22ILA641 22JLA662 22KLA836 22KLA939 22LLA399 25KMB595 25LMA384; DYNJ30077D Lots 21ABB348 21ABR327 21DBQ397 21FBM873 21GBL539 21IBB390 21JBO220 21KBC302 21KBV079 21LBT528 22ABZ834 22DBD744 22EBG375 22JBK533 22KBO291 22OBM411 23ABD824 23ABO419 23DBB788 23EBS951 23HBB563 23IBG762 23JBT149 24CBR583; DYNJ32555C Lots 21DMA301 21DMD929 21EMB686 21FMA163 22KMD644 23AMB073 24LMH114 25BMA103 25BMD349; DYNJ46153B Lots 21CBL359 21FBE618 21GBF346 21HBQ716 21IBW154 21KBI853 21LBA401 22ABE877 22BBW978 22CBU323 22EBN725 22FBQ420 22GBJ229 22HBD581 22IBL258 22JBM061 22KBD440 22NBA199 23ABG769 23BBE724 25BBR850 25EBA187; DYNJ47710C Lots 21CBM120 21GBL622 21KBA849 21KBA925 22ABX239 22CBP654 22JBI023 22LBR933 23BBT611 25BBF414 25CBJ501; DYNJ61015B Lots 21AMB131 21BMB923 21BMC128 21CMD384 21DMD441 21FMD102 21GME205 21JMG652 22AMD050 22AME244 22DME869 22FMA872 22FMD246 22GMG534 22IMB779 22IMF574 22JMG963 23AMD815 23BMB886 23DMC707; DYNJ66631 Lots 21IBH359 21VBC892 22BBW852 22DBJ281 22EBJ532 22GBA380", "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" } } ] } ] }