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  "name": "Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.",
  "description": "FDA recall Z-1818-2026 — Integra LifeSciences Corp. (NeuroSciences) is recalling Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. (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": "FDA recall Z-1818-2026: Integra LifeSciences Corp. (NeuroSciences) is recalling Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.",
      "text": "The FDA logged enforcement record Z-1818-2026: Integra LifeSciences Corp. (NeuroSciences) is voluntarily recalling Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. — reason: Increased rate of out-of-specification endotoxin results.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-19. Affected lots/codes: Product ID: WSM1015. UDI-DI: 00386190001455. Lot Numbers: 7579681, 7582225, 7583893, 7582227, 7591942, 7591944, 7583935, 7594266, 7593018, 7594288, 7594284, 7593013.. A RECORDED FDA enforcement action (occurred=true).",
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      "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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      "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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