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  "name": "Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565",
  "description": "FDA recall Z-1848-2023 — TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565 (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": "Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1848-2023/enforcement-record",
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      "name": "FDA recall Z-1848-2023: TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565",
      "text": "The FDA logged enforcement record Z-1848-2023: TELEFLEX LLC is voluntarily recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565 — 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 4026704547609, Batch Numbers:  18FG05, 18FG13, 18FG25, 18GG20, 18HG07, 18HG12, 18HG19, 18HG32, 18HG38, 18IG06, 18IG09, 18IG15, 18JG04, 18JG21, 18JG34, 18KG35, 18LG39, 19AG01, 19AG24, 19AG27, 19AG37, 19CT32, 19CT41, 19CT58, 19CT65, 19DT06, 19DT20, 19DT33, 19ET32, 19ET54, 19ET60, 19FT24, 19FT41, 19GT28, 19GT38, 19HT10, 19HT66, 19IT14, 19IT25, 19JT18, 19JT29, 19JT42, 19JT57, 19KT08, 19KT41, 19KT55, 19LT32, 20AT09, 20AT14, 20AT25, 20AT53, 20BT27, 20CT05, 20CT12, 20CT36, 20CT44, 20DT09, 20ET04, 20ET16, 20GT14, KME20G0189, KME20G0316, KME20H2312, KME20H2585, KME20H2586, KME20H2587, KME20J0320, KME20J0570, KME20K0465, KME20K0939, KME20K1551, KME20K1628, KME20K2246, KME20L0488, KME20L1840, KME20M0022, KME20M0854, KME20M1102, KME20M1579, KME21K1128, KME21L0328, KME21L2340, KME21M2283, KME21M2446, KME21M2568, KME22A0675, KME22A2415, KME22A3028, KME22A3156, KME22A3313, KME22B0067, KME22B1218, KME22B1409, KME22C0499, KME22C0863, KME22C1073, KME22C1225, KME22C1655, KME22C1941, KME22D0747, KME22D0755, KME22F1616, KME22F1617, KME22G0632, KME22G1224, KME22G2467, KME22H1900, KME22H3348, KME22J1135, KME22J1136, KME22J1928, KME22J3352, KME22K2413, KME22K2414, KME22L0241, KME22L0242, KME22L1792. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1848-2023 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
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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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        "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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