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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1811-2025.jsonld",
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  "name": "Medline Kits containing Codman Disposable Perforator 14 mm:      1. CRANI ACCESSORY PACK  SKU DYNJ59270      2. CRANI PACK-LF  SKU DYNJ44805M    3. CRANIOTOMY  SKU CDS982719V  CDS982719W  DYNJ904168F  DYNJ908404B  DYNJ908723A  DYNJ908723C      4. CRANIOTOMY #IMF 56646-LF  SKU DYNJVB91001A    5. CRANIOTOMY CDS  SKU CDS981888X  CDS983467I    6. CRANIOTOMY PACK-LF  SKU DYNJ09882G  DYNJ09882I    7. CRANIOTOMY S NASSAU  SKU DYNJ905879G    8. MHC CRANIOTOMY  SKU DYNJ903713K  DYNJ903713L    9. PAD CRANIOTOMY  SKU DYNJ902149J",
  "description": "FDA recall Z-1811-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits containing Codman Disposable Perforator 14 mm:      1. CRANI ACCESSORY PACK  SKU DYNJ59270      2. CRANI PACK-LF  SKU DYNJ44805M    3. CRANIOTOMY  SKU CDS982719V  CDS982719W  DYNJ904168F  DYNJ908404B  DYNJ908723A  DYNJ908723C      4. CRANIOTOMY #IMF 56646-LF  SKU DYNJVB91001A    5. CRANIOTOMY CDS  SKU CDS981888X  CDS983467I    6. CRANIOTOMY PACK-LF  SKU DYNJ09882G  DYNJ09882I    7. CRANIOTOMY S NASSAU  SKU DYNJ905879G    8. MHC CRANIOTOMY  SKU DYNJ903713K  DYNJ903713L    9. PAD CRANIOTOMY  SKU DYNJ902149J (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/",
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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-1811-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Kits containing Codman Disposable Perforator 14 mm:      1. CRANI ACCESSORY PACK  SKU DYNJ59270      2. CRANI PACK-LF  SKU DYNJ44805M    3. CRANIOTOMY  SKU CDS982719V  CDS982719W  DYNJ904168F  DYNJ908404B  DYNJ908723A  DYNJ908723C      4. CRANIOTOMY #IMF 56646-LF  SKU DYNJVB91001A    5. CRANIOTOMY CDS  SKU CDS981888X  CDS983467I    6. CRANIOTOMY PACK-LF  SKU DYNJ09882G  DYNJ09882I    7. CRANIOTOMY S NASSAU  SKU DYNJ905879G    8. MHC CRANIOTOMY  SKU DYNJ903713K  DYNJ903713L    9. PAD CRANIOTOMY  SKU DYNJ902149J",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1811-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1811-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits containing Codman Disposable Perforator 14 mm:      1. CRANI ACCESSORY PACK  SKU DYNJ59270      2. CRANI PACK-LF  SKU DYNJ44805M    3. CRANIOTOMY  SKU CDS982719V  CDS982719W  DYNJ904168F  DYNJ908404B  DYNJ908723A  DYNJ908723C      4. CRANIOTOMY #IMF 56646-LF  SKU DYNJVB91001A    5. CRANIOTOMY CDS  SKU CDS981888X  CDS983467I    6. CRANIOTOMY PACK-LF  SKU DYNJ09882G  DYNJ09882I    7. CRANIOTOMY S NASSAU  SKU DYNJ905879G    8. MHC CRANIOTOMY  SKU DYNJ903713K  DYNJ903713L    9. PAD CRANIOTOMY  SKU DYNJ902149J",
      "text": "The FDA logged enforcement record Z-1811-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Kits containing Codman Disposable Perforator 14 mm:      1. CRANI ACCESSORY PACK  SKU DYNJ59270      2. CRANI PACK-LF  SKU DYNJ44805M    3. CRANIOTOMY  SKU CDS982719V  CDS982719W  DYNJ904168F  DYNJ908404B  DYNJ908723A  DYNJ908723C      4. CRANIOTOMY #IMF 56646-LF  SKU DYNJVB91001A    5. CRANIOTOMY CDS  SKU CDS981888X  CDS983467I    6. CRANIOTOMY PACK-LF  SKU DYNJ09882G  DYNJ09882I    7. CRANIOTOMY S NASSAU  SKU DYNJ905879G    8. MHC CRANIOTOMY  SKU DYNJ903713K  DYNJ903713L    9. PAD CRANIOTOMY  SKU DYNJ902149J — 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 ACCESSORY PACK SKU DYNJ59270 UDI-DI 10888277771512 (ea), 40888277771513 (case) Lots 23JDB683 23JDC548 24ADB783 24HDA822    2. CRANI PACK-LF SKU DYNJ44805M UDI-DI 10195327506872 (ea), 40195327506873 (case)  Lots 23JBI747 23KBL228 24ABG696 24CBM117 24EBQ114 24GBJ699    3. CRANIOTOMY SKU CDS982719V UDI-DI 10195327510831 (ea), 40195327510832 (case) Lots 23KBP461 23LBN381 24ABB119 24BBC547 24BBI145   SKU CDS982719W UDI-DI 10195327645090 (ea), 40195327645091 (case) Lots 24DBS813   SKU DYNJ904168F UDI-DI 10195327395728 (ea), 40195327395729 (case) Lots 24DBU188   SKU DYNJ908404B UDI-DI 10195327410506 (ea), 40195327410507 (case) Lots 23IDB680 23LDB546 24BDB174 24FDA741 24FDB584 24IDA225 24IDA646 24IDA840   SKU DYNJ908723A UDI-DI 10195327403270 (ea), 40195327403271 (case) Lots 23IBO314 23JBC218 24ABK090   SKU DYNJ908723C UDI-DI 10198459009785 (ea), 40198459009786 (case) Lots 24IBM205 24IBN365 25ABM356   4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A UDI-DI 10195327466466 (ea), 40195327466467 (case) Lots 23JLA765 24DLA724 24DLB006 24ELA325   5. CRANIOTOMY CDS SKU CDS981888X UDI-DI 10195327144760 (ea), 40195327144761 (case) Lots 24ABT432 24CBD698 24HBH954 24HBP483 24IBG797 25CBF098   SKU CDS983467I UDI-DI 10195327457945 (ea), 40195327457946 (case) Lots 23KDA336   6. CRANIOTOMY PACK-LF SKU DYNJ09882G UDI-DI 10195327574055 (ea), 40195327574056 (case) Lots  24CBF778   SKU DYNJ09882I UDI-DI 10198459058172 (ea), 40198459058173 (case) Lots 24HBN426   7. CRANIOTOMY S NASSAU SKU DYNJ905879G UDI-DI 10195327512996 (ea), 40195327512997 (case) Lots 23KBI086 23LBH647 23LBH649 24BBU253 24DBV133 24FBE409   8. MHC CRANIOTOMY SKU DYNJ903713K UDI-DI 10195327201579 (ea), 40195327201570 (case) Lots 23JBK426   SKU DYNJ903713L UDI-DI 10195327531218 (ea), 40195327531219 (case) Lots 23KBT939 23LBS862 24ABH577 24CBH126 24CBH771   9. PAD CRANIOTOMY SKU DYNJ902149J UDI-DI 10195327554323 (ea), 40195327554324 (case) Lots 23KBP275 24ABJ684 24CBF216 24DBI296 24EBD959 24FBF064 24HBK164 24IBN443. 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-1811-2025&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-1811-2025&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-1811-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1811-2025 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-1811-2025&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-1811-2025&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-1811-2025/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."
    }
  ],
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      "name": "FDA recall details — Z-1811-2025",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1811-2025",
            "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 I",
            "Status": "determination"
          }
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          "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": "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1. CRANI ACCESSORY PACK SKU DYNJ59270 UDI-DI 10888277771512 (ea), 40888277771513 (case) Lots 23JDB683 23JDC548 24ADB783 24HDA822    2. CRANI PACK-LF SKU DYNJ44805M UDI-DI 10195327506872 (ea), 40195327506873 (case)  Lots 23JBI747 23KBL228 24ABG696 24CBM117 24EBQ114 24GBJ699    3. CRANIOTOMY SKU CDS982719V UDI-DI 10195327510831 (ea), 40195327510832 (case) Lots 23KBP461 23LBN381 24ABB119 24BBC547 24BBI145   SKU CDS982719W UDI-DI 10195327645090 (ea), 40195327645091 (case) Lots 24DBS813   SKU DYNJ904168F UDI-DI 10195327395728 (ea), 40195327395729 (case) Lots 24DBU188   SKU DYNJ908404B UDI-DI 10195327410506 (ea), 40195327410507 (case) Lots 23IDB680 23LDB546 24BDB174 24FDA741 24FDB584 24IDA225 24IDA646 24IDA840   SKU DYNJ908723A UDI-DI 10195327403270 (ea), 40195327403271 (case) Lots 23IBO314 23JBC218 24ABK090   SKU DYNJ908723C UDI-DI 10198459009785 (ea), 40198459009786 (case) Lots 24IBM205 24IBN365 25ABM356   4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A UDI-DI 10195327466466 (ea), 40195327466467 (case) Lots 23JLA765 24DLA724 24DLB006 24ELA325   5. CRANIOTOMY CDS SKU CDS981888X UDI-DI 10195327144760 (ea), 40195327144761 (case) Lots 24ABT432 24CBD698 24HBH954 24HBP483 24IBG797 25CBF098   SKU CDS983467I UDI-DI 10195327457945 (ea), 40195327457946 (case) Lots 23KDA336   6. CRANIOTOMY PACK-LF SKU DYNJ09882G UDI-DI 10195327574055 (ea), 40195327574056 (case) Lots  24CBF778   SKU DYNJ09882I UDI-DI 10198459058172 (ea), 40198459058173 (case) Lots 24HBN426   7. CRANIOTOMY S NASSAU SKU DYNJ905879G UDI-DI 10195327512996 (ea), 40195327512997 (case) Lots 23KBI086 23LBH647 23LBH649 24BBU253 24DBV133 24FBE409   8. MHC CRANIOTOMY SKU DYNJ903713K UDI-DI 10195327201579 (ea), 40195327201570 (case) Lots 23JBK426   SKU DYNJ903713L UDI-DI 10195327531218 (ea), 40195327531219 (case) Lots 23KBT939 23LBS862 24ABH577 24CBH126 24CBH771   9. PAD CRANIOTOMY SKU DYNJ902149J UDI-DI 10195327554323 (ea), 40195327554324 (case) Lots 23KBP275 24ABJ684 24CBF216 24DBI296 24EBD959 24FBF064 24HBK164 24IBN443",
            "Status": "recorded"
          }
        },
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          "@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"
          }
        }
      ]
    }
  ]
}