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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1887-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    EXTREMITY PACK\tDYNJ34846C  \t  HAND PACK\tDYNJ83218A, DYNJ85396  \t  LAMINECTOMY\tDYNJ905156R  \t  MAJOR EXTREMITY\tDYNJ905159L, DYNJ905159M  \t  MAJOR EXTREMITY PACK\tDYNJ69926A  \t  PODIATRY PACK\tDYNJ41250B",
  "description": "FDA recall Z-1887-2026 — Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    EXTREMITY PACK\tDYNJ34846C  \t  HAND PACK\tDYNJ83218A, DYNJ85396  \t  LAMINECTOMY\tDYNJ905156R  \t  MAJOR EXTREMITY\tDYNJ905159L, DYNJ905159M  \t  MAJOR EXTREMITY PACK\tDYNJ69926A  \t  PODIATRY PACK\tDYNJ41250B (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/",
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  "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"
    }
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1887-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    EXTREMITY PACK\tDYNJ34846C  \t  HAND PACK\tDYNJ83218A, DYNJ85396  \t  LAMINECTOMY\tDYNJ905156R  \t  MAJOR EXTREMITY\tDYNJ905159L, DYNJ905159M  \t  MAJOR EXTREMITY PACK\tDYNJ69926A  \t  PODIATRY PACK\tDYNJ41250B",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1887-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1887-2026: Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    EXTREMITY PACK\tDYNJ34846C  \t  HAND PACK\tDYNJ83218A, DYNJ85396  \t  LAMINECTOMY\tDYNJ905156R  \t  MAJOR EXTREMITY\tDYNJ905159L, DYNJ905159M  \t  MAJOR EXTREMITY PACK\tDYNJ69926A  \t  PODIATRY PACK\tDYNJ41250B",
      "text": "The FDA logged enforcement record Z-1887-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    EXTREMITY PACK\tDYNJ34846C  \t  HAND PACK\tDYNJ83218A, DYNJ85396  \t  LAMINECTOMY\tDYNJ905156R  \t  MAJOR EXTREMITY\tDYNJ905159L, DYNJ905159M  \t  MAJOR EXTREMITY PACK\tDYNJ69926A  \t  PODIATRY PACK\tDYNJ41250B — 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: DYNJ34846C  UDI-DI 10193489781441 (EA) 40193489781442 (CS) LOT  24BBA459     DYNJ83218A  UDI-DI 10195327382308 (EA) 40195327382309 (CS) LOT  24BBD199     DYNJ85396  UDI-DI 10195327497613 (EA) 40195327497614 (CS) LOT  24BBA503     DYNJ905156R  UDI-DI 10198459017704 (EA) 40198459017705 (CS)  LOTS  24HBG726    24JBJ484    25ABS758    25BBR196    25CBN174    25EBE136     DYNJ905159L  UDI-DI 10195327664251 (EA) 40195327664252 (CS) LOT  24EMB726     DYNJ905159M  UDI-DI 10198459017735 (EA) 40198459017736 (CS) LOT  24GMA714    24HMD401    24HMJ945    24JMD201    24KMG592    25AMC024    25BMD945    25CMG373     DYNJ69926A  UDI-DI 10195327153601 (EA) 40195327153602 (CS) LOT  24ABS445     DYNJ41250B  UDI-DI 10888277801257 (EA) 40888277801258 (CS) LOT  24ABO122  ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.***  DYNJ905156R lots 24GBD135 24IBK563 24IBS862 25BBH767. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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        "supported": true,
        "adjudged": true,
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        "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-1887-2026&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-1887-2026&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-1887-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1887-2026 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
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      "grounding": {
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        "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-1887-2026&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-1887-2026&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-1887-2026/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,
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        "adjudged": false,
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      "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-1887-2026",
      "numberOfItems": 9,
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          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1887-2026",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medline Industries, LP",
            "Status": "recorded"
          }
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        {
          "@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": "DYNJ34846C  UDI-DI 10193489781441 (EA) 40193489781442 (CS) LOT  24BBA459     DYNJ83218A  UDI-DI 10195327382308 (EA) 40195327382309 (CS) LOT  24BBD199     DYNJ85396  UDI-DI 10195327497613 (EA) 40195327497614 (CS) LOT  24BBA503     DYNJ905156R  UDI-DI 10198459017704 (EA) 40198459017705 (CS)  LOTS  24HBG726    24JBJ484    25ABS758    25BBR196    25CBN174    25EBE136     DYNJ905159L  UDI-DI 10195327664251 (EA) 40195327664252 (CS) LOT  24EMB726     DYNJ905159M  UDI-DI 10198459017735 (EA) 40198459017736 (CS) LOT  24GMA714    24HMD401    24HMJ945    24JMD201    24KMG592    25AMC024    25BMD945    25CMG373     DYNJ69926A  UDI-DI 10195327153601 (EA) 40195327153602 (CS) LOT  24ABS445     DYNJ41250B  UDI-DI 10888277801257 (EA) 40888277801258 (CS) LOT  24ABO122  ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.***  DYNJ905156R lots 24GBD135 24IBK563 24IBS862 25BBH767",
            "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"
          }
        }
      ]
    }
  ]
}