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  "name": "Amingo. OUS only.",
  "description": "FDA recall Z-0079-2025 — Datex-Ohmeda, Inc. is recalling Amingo. OUS only. (Devices, Class I). 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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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      "name": "FDA recall Z-0079-2025: Datex-Ohmeda, Inc. is recalling Amingo. OUS only.",
      "text": "The FDA logged enforcement record Z-0079-2025: Datex-Ohmeda, Inc. is voluntarily recalling Amingo. OUS only. — reason: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet  (ACGO) port.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-12. Affected lots/codes: GTIN: 00840682102322. Model Number: 1009-9013-000. All Serial Numbers.  Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0079-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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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        "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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            "Status": "recorded"
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