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  "name": "Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.",
  "description": "FDA recall Z-1900-2025 — Silex Medical, LLC is recalling Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033. (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-1900-2025: Silex Medical, LLC is recalling Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.",
      "text": "The FDA logged enforcement record Z-1900-2025: Silex Medical, LLC is voluntarily recalling Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033. — reason: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-09. Affected lots/codes: Model/REF Number: 5881033. UDI-DI: B33158810330. Lot Number: M28188. Serial Numbers: 0107, 0108.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1900-2025 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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