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  "name": "8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿    REF 470246",
  "description": "FDA recall Z-0862-2025 — Intuitive Surgical, Inc. is recalling 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿    REF 470246 (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-0862-2025: Intuitive Surgical, Inc. is recalling 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿    REF 470246",
      "text": "The FDA logged enforcement record Z-0862-2025: Intuitive Surgical, Inc. is voluntarily recalling 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿    REF 470246 — reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-19. Affected lots/codes: Model Number: 470246 Part Number: 470246-09 UDI-DI code: 00886874112397 Batch Numbers: K10230219 K10230226 K10230525 K10230601 K10230608 K10230615 K10231218 K10240104 K10240111 K10240411 K10240613 K10240620 K10240711 K10240725. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0862-2025 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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      "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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