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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1809-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Kits containing Codman Disposable Perforator 14 mm:    1. CRANI ADD A PACK, SKU DYNJ30926O  2. CRANIOTOMY, SKU CDS983611N  3. CRANIOTOMY CDS, SKU CDS983467J  4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927  5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A",
  "description": "FDA recall Z-1809-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits containing Codman Disposable Perforator 14 mm:    1. CRANI ADD A PACK, SKU DYNJ30926O  2. CRANIOTOMY, SKU CDS983611N  3. CRANIOTOMY CDS, SKU CDS983467J  4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927  5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A (Devices, Class I). 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": {
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      "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-1809-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Kits containing Codman Disposable Perforator 14 mm:    1. CRANI ADD A PACK, SKU DYNJ30926O  2. CRANIOTOMY, SKU CDS983611N  3. CRANIOTOMY CDS, SKU CDS983467J  4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927  5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1809-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1809-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits containing Codman Disposable Perforator 14 mm:    1. CRANI ADD A PACK, SKU DYNJ30926O  2. CRANIOTOMY, SKU CDS983611N  3. CRANIOTOMY CDS, SKU CDS983467J  4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927  5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A",
      "text": "The FDA logged enforcement record Z-1809-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Kits containing Codman Disposable Perforator 14 mm:    1. CRANI ADD A PACK, SKU DYNJ30926O  2. CRANIOTOMY, SKU CDS983611N  3. CRANIOTOMY CDS, SKU CDS983467J  4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927  5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A — reason: Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-04-22. Affected lots/codes: 1. CRANI ADD A PACK, SKU DYNJ30926O, UDI-DI 10195327539153 (EA), 40195327539154 (CASE)  KIT LOTS 24AMF811   2. CRANIOTOMY, SKU CDS983611N, UDI-DI 10195327466626 (EA), 40195327466627 (CASE)  KIT LOTS   23KBA720 23LBI611 23LBJ586  3. CRANIOTOMY CDS, SKU CDS983467J, UDI-DI 10195327561116 (EA),  40195327561117 (CASE)  KIT LOTS  24ADA818 24ADC216 24BDA929 24DDB447 24EDA275 24EDA751 24GDB213 24IDA327 24IDB043   4. CRANIOTOMY PACK, SKU DYNJ85807A, UDI-DI 10195327637392 (EA), 40195327637393 (CASE)  KIT LOTS 24CBB843 24EBC889 24GBY029 ;   SKU DYNJ85927, UDI-DI 10195327575571 (EA), 40195327575572 (CASE)  KIT LOTS 24BMD310 24EMI836   5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A UDI-DI 10195327635466 (EA), 40195327635467 (CASE)  KIT LOTS 24CMA496 24HMI081 24HMI978. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": 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-1809-2025&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-1809-2025&lang=eng"
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      },
      "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-1809-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1809-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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": {
        "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-1809-2025&lang=eng",
        "value": "Class I",
        "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-1809-2025&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-1809-2025/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": {
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        "supported": true,
        "adjudged": false,
        "operative": true
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        "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": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1809-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1809-2025",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "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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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-04-22",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1. CRANI ADD A PACK, SKU DYNJ30926O, UDI-DI 10195327539153 (EA), 40195327539154 (CASE)  KIT LOTS 24AMF811   2. CRANIOTOMY, SKU CDS983611N, UDI-DI 10195327466626 (EA), 40195327466627 (CASE)  KIT LOTS   23KBA720 23LBI611 23LBJ586  3. CRANIOTOMY CDS, SKU CDS983467J, UDI-DI 10195327561116 (EA),  40195327561117 (CASE)  KIT LOTS  24ADA818 24ADC216 24BDA929 24DDB447 24EDA275 24EDA751 24GDB213 24IDA327 24IDB043   4. CRANIOTOMY PACK, SKU DYNJ85807A, UDI-DI 10195327637392 (EA), 40195327637393 (CASE)  KIT LOTS 24CBB843 24EBC889 24GBY029 ;   SKU DYNJ85927, UDI-DI 10195327575571 (EA), 40195327575572 (CASE)  KIT LOTS 24BMD310 24EMI836   5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A UDI-DI 10195327635466 (EA), 40195327635467 (CASE)  KIT LOTS 24CMA496 24HMI081 24HMI978",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}