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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3253-2024.jsonld",
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  "name": "Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.  Order Number (GPN): G54613",
  "description": "FDA recall Z-3253-2024 — Cook Biotech, Inc. is recalling Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.  Order Number (GPN): G54613 (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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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-3253-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.  Order Number (GPN): G54613",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Cook Biotech, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3253-2024/enforcement-record",
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      "name": "FDA recall Z-3253-2024: Cook Biotech, Inc. is recalling Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.  Order Number (GPN): G54613",
      "text": "The FDA logged enforcement record Z-3253-2024: Cook Biotech, Inc. is voluntarily recalling Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.  Order Number (GPN): G54613 — reason: Products expire prior to the expiration date printed on the product labeling. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-07. Affected lots/codes: UDI: (01)00827002546134(17)  Lot Number:  LB1524439 LB1524440 LB1524442 LB1524443 LB1524445 LB1524463 LB1524466 LB1524468 LB1524475 LB1524479 LB1524481¿ LB1524490 LB1524493 LB1525896 LB1525901 LB1525907 LB1526905 LB1527067 LB1527075 LB1530306 LB1530313 LB1531711 LB1531739 LB1533341 LB1533352 LB1536078 LB1536107 LB1537839 LB1537859 LB1539734 LB1539735 LB1540185. 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": {
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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-3253-2024&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-3253-2024&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-3253-2024/fda-classification",
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      "name": "FDA classified recall Z-3253-2024 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.",
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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        }
      },
      "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-3253-2024/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,
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        "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-3253-2024",
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            "Value": "Z-3253-2024",
            "Status": "recorded"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Cook Biotech, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Products expire prior to the expiration date printed on the product labeling",
            "Status": "recorded"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-08-07",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "UDI: (01)00827002546134(17)  Lot Number:  LB1524439 LB1524440 LB1524442 LB1524443 LB1524445 LB1524463 LB1524466 LB1524468 LB1524475 LB1524479 LB1524481¿ LB1524490 LB1524493 LB1525896 LB1525901 LB1525907 LB1526905 LB1527067 LB1527075 LB1530306 LB1530313 LB1531711 LB1531739 LB1533341 LB1533352 LB1536078 LB1536107 LB1537839 LB1537859 LB1539734 LB1539735 LB1540185",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,  China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,  Norway, South Africa, United Kingdom.",
            "Status": "recorded"
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