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  "name": "SURG STRP 2X6  Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.",
  "description": "FDA recall Z-0254-2025 — Integra LifeSciences Corp. is recalling SURG STRP 2X6  Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery. (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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    "name": "SURG STRP 2X6  Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.",
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      "name": "FDA recall Z-0254-2025: Integra LifeSciences Corp. is recalling SURG STRP 2X6  Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.",
      "text": "The FDA logged enforcement record Z-0254-2025: Integra LifeSciences Corp. is voluntarily recalling SURG STRP 2X6  Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery. — reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods. Status: Ongoing — the recall is still being carried out.. Initiated 2024-09-20. Affected lots/codes: UDI-DI: 10381780515111,  20886704036637 Note: the same product code was distributed for a few years under JnJ under a transition agreement with Integra. Therefore, 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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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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      "name": "FDA classified recall Z-0254-2025 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.",
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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."
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      "@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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      "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": "Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods",
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            "Status": "recorded"
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