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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1190-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline medical procedure convenience kits labeled as:    1)\tMIDDLE EAR CDS, Kit SKU CDS984347O;   2)\tHEAD AND NECK CDS-LF, Kit SKU CDS984857N;   3)\tNECK PACK-LF, Kit SKU DYNJ0966130K;   4)\tNECKLINE PACK-LF, Kit SKU DYNJ51440B;   5)\tTHYROID PACK, Kit SKU DYNJ58742J;   6)\tENT I, Kit SKU DYNJ63781B;   7)\tNECK PACK, Kit SKU DYNJ82751B;   8)\tNOSE PACK, Kit SKU DYNJ82753C;   9)\tWMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.",
  "description": "FDA recall Z-1190-2026 — Medline Industries, LP is recalling Medline medical procedure convenience kits labeled as:    1)\tMIDDLE EAR CDS, Kit SKU CDS984347O;   2)\tHEAD AND NECK CDS-LF, Kit SKU CDS984857N;   3)\tNECK PACK-LF, Kit SKU DYNJ0966130K;   4)\tNECKLINE PACK-LF, Kit SKU DYNJ51440B;   5)\tTHYROID PACK, Kit SKU DYNJ58742J;   6)\tENT I, Kit SKU DYNJ63781B;   7)\tNECK PACK, Kit SKU DYNJ82751B;   8)\tNOSE PACK, Kit SKU DYNJ82753C;   9)\tWMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G. (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/",
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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-1190-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline medical procedure convenience kits labeled as:    1)\tMIDDLE EAR CDS, Kit SKU CDS984347O;   2)\tHEAD AND NECK CDS-LF, Kit SKU CDS984857N;   3)\tNECK PACK-LF, Kit SKU DYNJ0966130K;   4)\tNECKLINE PACK-LF, Kit SKU DYNJ51440B;   5)\tTHYROID PACK, Kit SKU DYNJ58742J;   6)\tENT I, Kit SKU DYNJ63781B;   7)\tNECK PACK, Kit SKU DYNJ82751B;   8)\tNOSE PACK, Kit SKU DYNJ82753C;   9)\tWMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1190-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1190-2026: Medline Industries, LP is recalling Medline medical procedure convenience kits labeled as:    1)\tMIDDLE EAR CDS, Kit SKU CDS984347O;   2)\tHEAD AND NECK CDS-LF, Kit SKU CDS984857N;   3)\tNECK PACK-LF, Kit SKU DYNJ0966130K;   4)\tNECKLINE PACK-LF, Kit SKU DYNJ51440B;   5)\tTHYROID PACK, Kit SKU DYNJ58742J;   6)\tENT I, Kit SKU DYNJ63781B;   7)\tNECK PACK, Kit SKU DYNJ82751B;   8)\tNOSE PACK, Kit SKU DYNJ82753C;   9)\tWMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.",
      "text": "The FDA logged enforcement record Z-1190-2026: Medline Industries, LP is voluntarily recalling Medline medical procedure convenience kits labeled as:    1)\tMIDDLE EAR CDS, Kit SKU CDS984347O;   2)\tHEAD AND NECK CDS-LF, Kit SKU CDS984857N;   3)\tNECK PACK-LF, Kit SKU DYNJ0966130K;   4)\tNECKLINE PACK-LF, Kit SKU DYNJ51440B;   5)\tTHYROID PACK, Kit SKU DYNJ58742J;   6)\tENT I, Kit SKU DYNJ63781B;   7)\tNECK PACK, Kit SKU DYNJ82751B;   8)\tNOSE PACK, Kit SKU DYNJ82753C;   9)\tWMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G. — reason: Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-12. Affected lots/codes: Medline Kit SKU CDS984347O:  UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMD733;  Medline Kit SKU CDS984347O:  UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMC147;  Medline Kit SKU CDS984857N:  UDI/DI 10198459359705 (EA) 40198459359706 (CS), Lot Number 25KMJ151;  Medline Kit SKU DYNJ0966130K:  UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25LMB220;  Medline Kit SKU DYNJ0966130K:  UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25KME804;  Medline Kit SKU DYNJ51440B:  UDI/DI 10198459004230 (EA) 40198459004231 (CS), Lot Number 25KMI445;  Medline Kit SKU DYNJ58742J:  UDI/DI 10198459254710 (EA) 40198459254711 (CS), Lot Number 25KMC534;  Medline Kit SKU DYNJ63781B:  UDI/DI 10198459549595 (EA) 40198459549596 (CS), Lot Number 25KMB410;  Medline Kit SKU DYNJ82751B:  UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25LMB068;  Medline Kit SKU DYNJ82751B:  UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25KMI309;  Medline Kit SKU DYNJ82753C:  UDI/DI 10198459446887 (EA) 40198459446888 (CS), Lot Number 25KMC126;  Medline Kit SKU DYNJ907206G:  UDI/DI 10198459368028 (EA) 40198459368029 (CS), Lot Number 25KBL336.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-1190-2026&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-1190-2026&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-1190-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1190-2026 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-1190-2026&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-1190-2026&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-1190-2026/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-1190-2026",
      "numberOfItems": 9,
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          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1190-2026",
            "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 kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-12-12",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Medline Kit SKU CDS984347O:  UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMD733;  Medline Kit SKU CDS984347O:  UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMC147;  Medline Kit SKU CDS984857N:  UDI/DI 10198459359705 (EA) 40198459359706 (CS), Lot Number 25KMJ151;  Medline Kit SKU DYNJ0966130K:  UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25LMB220;  Medline Kit SKU DYNJ0966130K:  UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25KME804;  Medline Kit SKU DYNJ51440B:  UDI/DI 10198459004230 (EA) 40198459004231 (CS), Lot Number 25KMI445;  Medline Kit SKU DYNJ58742J:  UDI/DI 10198459254710 (EA) 40198459254711 (CS), Lot Number 25KMC534;  Medline Kit SKU DYNJ63781B:  UDI/DI 10198459549595 (EA) 40198459549596 (CS), Lot Number 25KMB410;  Medline Kit SKU DYNJ82751B:  UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25LMB068;  Medline Kit SKU DYNJ82751B:  UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25KMI309;  Medline Kit SKU DYNJ82753C:  UDI/DI 10198459446887 (EA) 40198459446888 (CS), Lot Number 25KMC126;  Medline Kit SKU DYNJ907206G:  UDI/DI 10198459368028 (EA) 40198459368029 (CS), Lot Number 25KBL336.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}