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  "name": "AMS Artificial Urinary Sphincter Control Pump",
  "description": "FDA recall Z-0530-2025 — Boston Scientific Corporation is recalling AMS Artificial Urinary Sphincter Control Pump (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-0530-2025: Boston Scientific Corporation is recalling AMS Artificial Urinary Sphincter Control Pump",
      "text": "The FDA logged enforcement record Z-0530-2025: Boston Scientific Corporation is voluntarily recalling AMS Artificial Urinary Sphincter Control Pump — reason: Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098). Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-28. Affected lots/codes: UPN Number: 72400098. GTIN Number: 00878953000688. Lot Number: 32487464. Serial Numbers: 1100366307, 1100366316, 1100366309, 1100366317, 1100366310, 1100366319, 1100366311, 1100366320, 1100366312, 1100366321, 1100366313, 1100366323, 1100366314, 1100366324, 1100366315, 1100366325.    Expiration Date: 09/24/2028. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0530-2025 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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      "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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      "reviewStatus": "current",
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        "adjudicator": null
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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": "Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)",
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            "Value": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.",
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