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  "name": "Allwell Inflation Device, for angiographic use REF: IS-30-A",
  "description": "FDA recall Z-1124-2026 — Merit Medical Systems, Inc. is recalling Allwell Inflation Device, for angiographic use REF: IS-30-A (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": "Allwell Inflation Device, for angiographic use REF: IS-30-A",
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      "name": "FDA recall Z-1124-2026: Merit Medical Systems, Inc. is recalling Allwell Inflation Device, for angiographic use REF: IS-30-A",
      "text": "The FDA logged enforcement record Z-1124-2026: Merit Medical Systems, Inc. is voluntarily recalling Allwell Inflation Device, for angiographic use REF: IS-30-A — reason: Inflation device handle may detach from the syringe during procedure.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-04. Affected lots/codes: UDI: 00884450653500 /Lot: I2559701 I2563344 I2567488 I2578111 I2593681 I2593683 I2603907 I2617788 I2622059 I2628990 I2653159 I2657407 I2853633 I2887859 I2887860 I2892046 I2917191 I2921522 I2927924 I2933535 I2989185 I2989187 I3027377 I3027378 I3037369 I3085686 I3085687 I3103552 I3118248 I3118249 I3154769 I3186052 I3186054 I3186058 I3214004 I3245239 I3245240 I3248078 I3282794. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1124-2026 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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            "Status": "recorded"
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