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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1881-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes      BARIATRIC\tDYNJ905153M, DYNJ905153N  \t  GENERAL LAPAROSCOPY PACK\tDYNJ81602  \t  LAPAROSCOPY\tDYNJ905157K,\tDYNJ905157L  \t  LAPAROTOMY PACK\tDYNJ46675G  \t  MAJOR LITHOTOMY PACK\tDYNJ81607  \t  MAJOR PLUS PACK\tDYNJ905160O    MINOR GENERAL PACK\tDYNJ81599",
  "description": "FDA recall Z-1881-2026 — Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes      BARIATRIC\tDYNJ905153M, DYNJ905153N  \t  GENERAL LAPAROSCOPY PACK\tDYNJ81602  \t  LAPAROSCOPY\tDYNJ905157K,\tDYNJ905157L  \t  LAPAROTOMY PACK\tDYNJ46675G  \t  MAJOR LITHOTOMY PACK\tDYNJ81607  \t  MAJOR PLUS PACK\tDYNJ905160O    MINOR GENERAL PACK\tDYNJ81599 (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-1881-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes      BARIATRIC\tDYNJ905153M, DYNJ905153N  \t  GENERAL LAPAROSCOPY PACK\tDYNJ81602  \t  LAPAROSCOPY\tDYNJ905157K,\tDYNJ905157L  \t  LAPAROTOMY PACK\tDYNJ46675G  \t  MAJOR LITHOTOMY PACK\tDYNJ81607  \t  MAJOR PLUS PACK\tDYNJ905160O    MINOR GENERAL PACK\tDYNJ81599",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1881-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1881-2026: Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes      BARIATRIC\tDYNJ905153M, DYNJ905153N  \t  GENERAL LAPAROSCOPY PACK\tDYNJ81602  \t  LAPAROSCOPY\tDYNJ905157K,\tDYNJ905157L  \t  LAPAROTOMY PACK\tDYNJ46675G  \t  MAJOR LITHOTOMY PACK\tDYNJ81607  \t  MAJOR PLUS PACK\tDYNJ905160O    MINOR GENERAL PACK\tDYNJ81599",
      "text": "The FDA logged enforcement record Z-1881-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes      BARIATRIC\tDYNJ905153M, DYNJ905153N  \t  GENERAL LAPAROSCOPY PACK\tDYNJ81602  \t  LAPAROSCOPY\tDYNJ905157K,\tDYNJ905157L  \t  LAPAROTOMY PACK\tDYNJ46675G  \t  MAJOR LITHOTOMY PACK\tDYNJ81607  \t  MAJOR PLUS PACK\tDYNJ905160O    MINOR GENERAL PACK\tDYNJ81599 — 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: DYNJ905153M  UDI-DI 10195327556761 (EA) 40195327556762 (CS)  LOT 24CMG485     DYNJ905153N  UDI-DI 10198459017797 (EA) 40198459017798  (CS) LOT 25DMC254     DYNJ81602  UDI-DI 10195327123857 (EA) 40195327123858 (CS) LOT  24ABP080     DYNJ905157K  UDI-DI 10195327556921 (EA) 40195327556922 (CS) LOTS 24DMF349  24EMC297     DYNJ905157L  UDI-DI 10198459017711 (EA) 40198459017712 (CS) LOTS  24FMD083    24HMD400    24IME332    24JMA234    24KMG588    25AMA393    25AMJ541    25BMI202    25CMD909    25CMH371     DYNJ46675G  UDI-DI 10195327419066 (EA) 40195327419067 (CS) LOT  24ABS814     DYNJ81607  UDI-DI 10195327123918 (EA) 40195327123919 (CS)  LOT 24ABP097     DYNJ905160O  UDI-DI 10198459017742 (EA) 40198459017743 (CS)  LOTS 24HMG093    24IME714    24JMI924    24LMB556    25AME613    25BMJ076     DYNJ81599  UDI-DI 10195327124021 (EA) 40195327124022 (CS) LOT  24BBB847  ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.***  DYNJ905153M lots 24BMH968 24EMG682;  DYNJ905153N lots 24HMG087 24IMA442 24IMG245;  DYNJ905157K lots 23LME674 24AMH261 24AMJ205 24BME886 24CMD057. 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-1881-2026&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-1881-2026&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-1881-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1881-2026 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-1881-2026&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-1881-2026&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-1881-2026/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-1881-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1881-2026",
            "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": "DYNJ905153M  UDI-DI 10195327556761 (EA) 40195327556762 (CS)  LOT 24CMG485     DYNJ905153N  UDI-DI 10198459017797 (EA) 40198459017798  (CS) LOT 25DMC254     DYNJ81602  UDI-DI 10195327123857 (EA) 40195327123858 (CS) LOT  24ABP080     DYNJ905157K  UDI-DI 10195327556921 (EA) 40195327556922 (CS) LOTS 24DMF349  24EMC297     DYNJ905157L  UDI-DI 10198459017711 (EA) 40198459017712 (CS) LOTS  24FMD083    24HMD400    24IME332    24JMA234    24KMG588    25AMA393    25AMJ541    25BMI202    25CMD909    25CMH371     DYNJ46675G  UDI-DI 10195327419066 (EA) 40195327419067 (CS) LOT  24ABS814     DYNJ81607  UDI-DI 10195327123918 (EA) 40195327123919 (CS)  LOT 24ABP097     DYNJ905160O  UDI-DI 10198459017742 (EA) 40198459017743 (CS)  LOTS 24HMG093    24IME714    24JMI924    24LMB556    25AME613    25BMJ076     DYNJ81599  UDI-DI 10195327124021 (EA) 40195327124022 (CS) LOT  24BBB847  ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.***  DYNJ905153M lots 24BMH968 24EMG682;  DYNJ905153N lots 24HMG087 24IMA442 24IMG245;  DYNJ905157K lots 23LME674 24AMH261 24AMJ205 24BME886 24CMD057",
            "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"
          }
        }
      ]
    }
  ]
}