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  "name": "Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080",
  "description": "FDA recall Z-1890-2023 — TELEFLEX LLC is recalling Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080 (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 112082080",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1890-2023/enforcement-record",
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      "name": "FDA recall Z-1890-2023: TELEFLEX LLC is recalling Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080",
      "text": "The FDA logged enforcement record Z-1890-2023: TELEFLEX LLC is voluntarily recalling Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080 — 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 14026704341440, Batch Numbers: 18GG11, 18GG12, 18GG13, 18GT08, 18GT11, 18HG40, 18IG04, 18IG07, 18IG12, 18IG13, 18IG23, 18IT06, 18IT10, 18IT16, 18JG07, 18JG09, 18JG13, 18JG26, 18JG37, 18JG38, 18JT06, 18JT10, 19AG35, 19AG38, 19AT20, 19BG06, 19BG07, 19BG14, 19BG18, 19BG22, 19BG25, 19BG30, 19BT08, 19BT12, 19DT36, 19DT43, 19ET22, 19ET27, 19ET82, 19ET83, 19FT04, 19FT13, 19FT26, 19FT28, 19KT14, 19LT46, 19LT47, 19LT51, 20AT22, 20AT49, 20BG15, 20BG19, 20BT05, 20BT09, 20BT10, 20BT24, 20CT42, 20CT48, 20CT54, 20DT10, 20DT23, 20DT28, 20ET16, 20ET17, 20ET39, 20FT17, 20FT43, 20FT49, 20FT58, 20FT61, 20GG48, 20GT10, 20GT11, 20GT12, 20GT23, KME20G0436, KME20H0953, KME20L1706, KME20L2207, KME20L2333, KME20L2607, KME20L2696, KME20M1043, KME20M1342, KME21A1435, KME21A1524, KME21A2058, KME21B0616, KME21D1653, KME21D1946, KME21D2011, KME21D2012, KME21E0584, KME21E0687, KME21E1452, KME21F0981, KME21F1006, KME21F1215, KME21F1530, KME21F1604, KME21G0736, KME21G1100, KME21J0109, KME21J0563, KME21J1295, KME21J1364, KME21J1415, KME21J1532, KME21J2055, KME21K0022, KME21K0187, KME21K0449, KME21K2884, KME21K3013, KME21L0744, KME21L1438, KME21L1533, KME21L1661, KME21L1787, KME21L2012, KME21L2177, KME21M3032, KME21M3137, KME21M3236, KME22A0626, KME22A0793, KME22A1043, KME22A1701, KME22A2203, KME22A2429, KME22A2693, KME22A2966, KME22B0500, KME22B0737, KME22B0898, KME22B0915, KME22B0991, KME22C1987, KME22C2072, KME22C2219, KME22C2400, KME22C3376, KME22D0004, KME22D1589, KME22D1689, KME22D1897, KME22D2014, KME22D2505, KME22D2636, KME22D3062, KME22D3275, KME22D3421, KME22D3427, KME22D3712, KME22E2014, KME22F0621, KME22F2238, KME22J3346, KME22K0540, KME22K0541, KME22K0654, KME22K0691, KME22K0694, KME22K0715, KME22K0777, KME22M0921, KME23A0132, KME23A0714, KME23B1443. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-1890-2023 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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      "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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            "Field": "Recalling firm",
            "Value": "TELEFLEX LLC",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.",
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            "Field": "Initiated",
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            "Value": "UDI/DI 14026704341440, Batch Numbers: 18GG11, 18GG12, 18GG13, 18GT08, 18GT11, 18HG40, 18IG04, 18IG07, 18IG12, 18IG13, 18IG23, 18IT06, 18IT10, 18IT16, 18JG07, 18JG09, 18JG13, 18JG26, 18JG37, 18JG38, 18JT06, 18JT10, 19AG35, 19AG38, 19AT20, 19BG06, 19BG07, 19BG14, 19BG18, 19BG22, 19BG25, 19BG30, 19BT08, 19BT12, 19DT36, 19DT43, 19ET22, 19ET27, 19ET82, 19ET83, 19FT04, 19FT13, 19FT26, 19FT28, 19KT14, 19LT46, 19LT47, 19LT51, 20AT22, 20AT49, 20BG15, 20BG19, 20BT05, 20BT09, 20BT10, 20BT24, 20CT42, 20CT48, 20CT54, 20DT10, 20DT23, 20DT28, 20ET16, 20ET17, 20ET39, 20FT17, 20FT43, 20FT49, 20FT58, 20FT61, 20GG48, 20GT10, 20GT11, 20GT12, 20GT23, KME20G0436, KME20H0953, KME20L1706, KME20L2207, KME20L2333, KME20L2607, KME20L2696, KME20M1043, KME20M1342, KME21A1435, KME21A1524, KME21A2058, KME21B0616, KME21D1653, KME21D1946, KME21D2011, KME21D2012, KME21E0584, KME21E0687, KME21E1452, KME21F0981, KME21F1006, KME21F1215, KME21F1530, KME21F1604, KME21G0736, KME21G1100, KME21J0109, KME21J0563, KME21J1295, KME21J1364, KME21J1415, KME21J1532, KME21J2055, KME21K0022, KME21K0187, KME21K0449, KME21K2884, KME21K3013, KME21L0744, KME21L1438, KME21L1533, KME21L1661, KME21L1787, KME21L2012, KME21L2177, KME21M3032, KME21M3137, KME21M3236, KME22A0626, KME22A0793, KME22A1043, KME22A1701, KME22A2203, KME22A2429, KME22A2693, KME22A2966, KME22B0500, KME22B0737, KME22B0898, KME22B0915, KME22B0991, KME22C1987, KME22C2072, KME22C2219, KME22C2400, KME22C3376, KME22D0004, KME22D1589, KME22D1689, KME22D1897, KME22D2014, KME22D2505, KME22D2636, KME22D3062, KME22D3275, KME22D3421, KME22D3427, KME22D3712, KME22E2014, KME22F0621, KME22F2238, KME22J3346, KME22K0540, KME22K0541, KME22K0654, KME22K0691, KME22K0694, KME22K0715, KME22K0777, KME22M0921, KME23A0132, KME23A0714, KME23B1443",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution including Puerto Rico.",
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