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  "name": "Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB",
  "description": "FDA recall Z-0052-2025 — AURIS HEALTH INC is recalling Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB (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-0052-2025: AURIS HEALTH INC is recalling Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB",
      "text": "The FDA logged enforcement record Z-0052-2025: AURIS HEALTH INC is voluntarily recalling Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB — reason: Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-02. Affected lots/codes: Cart Power Cord 20' 14AWG BLK, PN 304-003613-00. Tower Power Cord 20' 14AWG BLK, PN 304-003607-00.  REF/UDI-DI/Serial Numbers: MON-000007/+B634MON0000070/120059, 120133, 210002;  MON-000007-RFB/10810068810889/210001.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0052-2025 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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      "@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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