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  "name": "Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085",
  "description": "FDA recall Z-1891-2023 — TELEFLEX LLC is recalling Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085 (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": "Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1891-2023/enforcement-record",
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      "name": "FDA recall Z-1891-2023: TELEFLEX LLC is recalling Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085",
      "text": "The FDA logged enforcement record Z-1891-2023: TELEFLEX LLC is voluntarily recalling Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085 — reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-25. Affected lots/codes: UDI/DI 14026704341457, Batch Numbers:  18HG37, 18HT15, 18HT24, 18JG12, 18JG31, 19CT69, 19CT73, 19CT74, 19CT76, 19CT77, 19DT05, 19DT10, 19KT14, 19KT30, 19KT46, 19KT49, 19KT50, 19KT55, 19LT35, 20BT51, 20CT02, 20CT22, 20CT28, 20CT32, 20CT42, 20DT02, 20DT17, 20DT18, 20ET17, 20GG43, KME20H0750, KME20J2539, KME20J2680, KME20K0923, KME20K1114, KME20K1513, KME20K3034, KME20K3146, KME20L1867, KME20L2274, KME20M1511, KME21E0902, KME21F0741, KME21F1214, KME21F2006, KME21F2074, KME21K0095, KME21K1193, KME21K2275, KME21K2575, KME21K3015, KME21L0394, KME21L0799, KME21L1115, KME21L1276, KME21L1586, KME21M2500, KME21M2728, KME22A0787, KME22A2287, KME22A2957, KME22A2968, KME22B0519, KME22B1154, KME22B1696, KME22B1775, KME22B2179, KME22B2320, KME22B2477, KME22B2797, KME22C2074, KME22D1891, KME22D1892, KME22D3186, KME22D3488, KME22D3564, KME22E0663, KME22E0988, KME22E1279, KME22E1583, KME22E1811, KME22E2253. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
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        "value": "Devices recall, status Ongoing",
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      "name": "FDA classified recall Z-1891-2023 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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      "reviewStatus": "current",
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        "supported": true,
        "adjudged": true,
        "operative": true
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        "value": "Class I",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
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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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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "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": "Ongoing — the recall is still being carried out.",
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            "Value": "TELEFLEX LLC",
            "Status": "recorded"
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            "Value": "UDI/DI 14026704341457, Batch Numbers:  18HG37, 18HT15, 18HT24, 18JG12, 18JG31, 19CT69, 19CT73, 19CT74, 19CT76, 19CT77, 19DT05, 19DT10, 19KT14, 19KT30, 19KT46, 19KT49, 19KT50, 19KT55, 19LT35, 20BT51, 20CT02, 20CT22, 20CT28, 20CT32, 20CT42, 20DT02, 20DT17, 20DT18, 20ET17, 20GG43, KME20H0750, KME20J2539, KME20J2680, KME20K0923, KME20K1114, KME20K1513, KME20K3034, KME20K3146, KME20L1867, KME20L2274, KME20M1511, KME21E0902, KME21F0741, KME21F1214, KME21F2006, KME21F2074, KME21K0095, KME21K1193, KME21K2275, KME21K2575, KME21K3015, KME21L0394, KME21L0799, KME21L1115, KME21L1276, KME21L1586, KME21M2500, KME21M2728, KME22A0787, KME22A2287, KME22A2957, KME22A2968, KME22B0519, KME22B1154, KME22B1696, KME22B1775, KME22B2179, KME22B2320, KME22B2477, KME22B2797, KME22C2074, KME22D1891, KME22D1892, KME22D3186, KME22D3488, KME22D3564, KME22E0663, KME22E0988, KME22E1279, KME22E1583, KME22E1811, KME22E2253",
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            "Field": "Distribution pattern",
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