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  "name": "ESG PK CUTTING FORCEPS, 5MM, 33CM",
  "description": "FDA recall Z-1167-2024 — Olympus Corporation of the Americas is recalling ESG PK CUTTING FORCEPS, 5MM, 33CM (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": "ESG PK CUTTING FORCEPS, 5MM, 33CM",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1167-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1167-2024: Olympus Corporation of the Americas is recalling ESG PK CUTTING FORCEPS, 5MM, 33CM",
      "text": "The FDA logged enforcement record Z-1167-2024: Olympus Corporation of the Americas is voluntarily recalling ESG PK CUTTING FORCEPS, 5MM, 33CM — reason: The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-15. Affected lots/codes: Model: PK-CF0533; UDI DI: 00821925035867; Lot Numbers: FR258486, FR261738, FR259544, FR263183, FR276278, FR279757, FR279625, FR279658, FR286369, FR287112, FR374622, FR207935, FR212413, FR212735, FR215061, FR216817, FR220525, FR222456, FR227254, FR227774, FR227781, FR232882, FR234845, FR247614, FR240430, FR246627, FR247039, FR248008, FR255679, FR248312, FR263636, FR263244, FR269280, FR269267, FR269269, FR287114, FR303799, FR297022, FR301062, PWO-308561, PWO-308562, PWO-308563, PWO-308560, PWO-308567, PWO-308566, PWO-308565, FR303864, FR313639, FR316869, FR319703, FR316872, FR327890, PWO-308972, FR335984, FR335990, FR337947, FR373912, FR401646, FR379790, FR347006;. A RECORDED FDA enforcement action (occurred=true).",
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      "commercialInfluence": false,
      "epistemicStatus": {
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        "supported": true,
        "adjudged": 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-1167-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-1167-2024&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."
    },
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1167-2024/fda-classification",
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      "name": "FDA classified recall Z-1167-2024 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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        }
      },
      "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-1167-2024/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.",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
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      "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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            "Value": "The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea.",
            "Status": "recorded"
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