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  "name": "Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530",
  "description": "FDA recall Z-1855-2023 — TELEFLEX LLC is recalling Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530 (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 Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1855-2023/enforcement-record",
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      "name": "FDA recall Z-1855-2023: TELEFLEX LLC is recalling Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530",
      "text": "The FDA logged enforcement record Z-1855-2023: TELEFLEX LLC is voluntarily recalling Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530 — 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 4026704547678, Batch Numbers:  18FG05, 18GG12, 18GG17, 18GG31, 18GT32, 18HG12, 18HG16, 18IG02, 18IG06, 18IG15, 18IG21, 18IG27, 18JG02, 18JG23, 18JG32, 18JG34, 18KG15, 18KG23, 18LG02, 18LG22, 18LG28, 19AG21, 19AG24, 19AG27, 19AG37, 19BG25, 19BG40, 19CT65, 19ET72, 19FT01, 19GT05, 19GT20, 19GT59, 19GT65, 19HT40, 19HT61, 19HT80, 19IT29, 19IT39, 19JT18, 19JT22, 19JT29, 19JT49, 19JT57, 19KT08, 19LT04, 19LT48, 20AT09, 20AT32, 20AT44, 20AT46, 20AT53, 20BT23, 20BT37, 20BT47, 20CT05, 20CT12, 20CT36, 20DT37, 20ET16, 20ET28, KME20J0318, KME20K0152, KME20K0153, KME20K0154, KME20K3587, KME20L1467, KME20L1468, KME20L1838, KME20M2048, KME20M2480, KME21A0669, KME21A1897, KME21A2807, KME21B1674, KME21B1675, KME21C0489, KME21M0865, KME21M2740, KME21M2741, KME22B2144, KME22B2326, KME22B2327, KME22C1075, KME22C1826, KME22C3192, KME22D0787, KME22E0223, KME22E1029, KME22F0563, KME22G0910, KME22G0911, KME22H0780, KME22H2909, KME22J0577, KME22K0015, KME22K0016, KME22K0202, KME22K0335, KME22K0918. 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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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
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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-1855-2023 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",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
        "operative": true
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class I",
        "adjudicator": {
          "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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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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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            "Value": "Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.",
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            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution including Puerto Rico.",
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