{
  "@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-0777-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline custom medical procedure kits labeled as:    1) CATH LAB PACK-LF, REF DYNJ0382559M;   2) CRANI, REF DYNJ56001B;   3) GENDER AFFIRMING SURGERY, REF DYNJ66252;   4) GENDER AFFIRMING SURGERY, REF DYNJ66252A;   5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.",
  "description": "FDA recall Z-0777-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline custom medical procedure kits labeled as:    1) CATH LAB PACK-LF, REF DYNJ0382559M;   2) CRANI, REF DYNJ56001B;   3) GENDER AFFIRMING SURGERY, REF DYNJ66252;   4) GENDER AFFIRMING SURGERY, REF DYNJ66252A;   5) MAJOR NEURO PACK-LF, REF DYNJ0578916X. (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-0777-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline custom medical procedure kits labeled as:    1) CATH LAB PACK-LF, REF DYNJ0382559M;   2) CRANI, REF DYNJ56001B;   3) GENDER AFFIRMING SURGERY, REF DYNJ66252;   4) GENDER AFFIRMING SURGERY, REF DYNJ66252A;   5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0777-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0777-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline custom medical procedure kits labeled as:    1) CATH LAB PACK-LF, REF DYNJ0382559M;   2) CRANI, REF DYNJ56001B;   3) GENDER AFFIRMING SURGERY, REF DYNJ66252;   4) GENDER AFFIRMING SURGERY, REF DYNJ66252A;   5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.",
      "text": "The FDA logged enforcement record Z-0777-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline custom medical procedure kits labeled as:    1) CATH LAB PACK-LF, REF DYNJ0382559M;   2) CRANI, REF DYNJ56001B;   3) GENDER AFFIRMING SURGERY, REF DYNJ66252;   4) GENDER AFFIRMING SURGERY, REF DYNJ66252A;   5) MAJOR NEURO PACK-LF, REF DYNJ0578916X. — reason: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-21. Affected lots/codes: 1) REF DYNJ0382559M, UDI/DI 10889942063994 (EA) 10889942063995 (CS), Lot Numbers:  19TBC792;     2) REF DYNJ56001B, UDI/DI 10889942798278 (EA) 40889942798279 (CS), Lot Numbers:  19BDC737, 19FDA310, 19FDB230, 19JDA441;   3) REF DYNJ66252, UDI/DI 10193489324785 (EA) 40193489324786 (CS), Lot numbers:  20DBK065, 20FBN251, 20HBL176, 20HBM692, 21CBP776;   4) REF DYNJ66252A, UDI/DI 10193489887853 (EA) 40193489887854 (CS), Lot numbers:  21IBN151, 21KBO915, 21LBJ105, 21VBB714;   5) REF DYNJ0578916X, UDI/DI 10193489288384 (EA) 40193489288385 (CS), Lot numbers: 22OBL262,20CKA219, 20CKA875, 20EKB076, 20GKA543, 20GKB272, 20IKB497, 20JKB716, 21AKA500, 21BKA195, 21FMD808, 21HMD657, 21IMB172, 21JMH627, 21KMH877, 21LMC161, 22AMA533, 22DMC612, 22DMI233, 22GMB685, 22IMA041, 23AMD730, 23DMA094, 23FMF542, 23IME618, 24AMA230.. 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-0777-2025&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-0777-2025&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-0777-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0777-2025 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-0777-2025&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-0777-2025&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-0777-2025/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-0777-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0777-2025",
            "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 - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-11-21",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) REF DYNJ0382559M, UDI/DI 10889942063994 (EA) 10889942063995 (CS), Lot Numbers:  19TBC792;     2) REF DYNJ56001B, UDI/DI 10889942798278 (EA) 40889942798279 (CS), Lot Numbers:  19BDC737, 19FDA310, 19FDB230, 19JDA441;   3) REF DYNJ66252, UDI/DI 10193489324785 (EA) 40193489324786 (CS), Lot numbers:  20DBK065, 20FBN251, 20HBL176, 20HBM692, 21CBP776;   4) REF DYNJ66252A, UDI/DI 10193489887853 (EA) 40193489887854 (CS), Lot numbers:  21IBN151, 21KBO915, 21LBJ105, 21VBB714;   5) REF DYNJ0578916X, UDI/DI 10193489288384 (EA) 40193489288385 (CS), Lot numbers: 22OBL262,20CKA219, 20CKA875, 20EKB076, 20GKA543, 20GKB272, 20IKB497, 20JKB716, 21AKA500, 21BKA195, 21FMD808, 21HMD657, 21IMB172, 21JMH627, 21KMH877, 21LMC161, 22AMA533, 22DMC612, 22DMI233, 22GMB685, 22IMA041, 23AMD730, 23DMA094, 23FMF542, 23IME618, 24AMA230.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of UAE, and Canada.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}