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  "name": "Medline 14 Fr Suction Catheter Kits  SKU DYND40972 - respiratory convenience kit",
  "description": "FDA recall Z-1312-2026 — Medline Industries, LP is recalling Medline 14 Fr Suction Catheter Kits  SKU DYND40972 - respiratory convenience kit (Devices, Class II). 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-1312-2026: Medline Industries, LP is recalling Medline 14 Fr Suction Catheter Kits  SKU DYND40972 - respiratory convenience kit",
      "text": "The FDA logged enforcement record Z-1312-2026: Medline Industries, LP is voluntarily recalling Medline 14 Fr Suction Catheter Kits  SKU DYND40972 - respiratory convenience kit — reason: A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-24. Affected lots/codes: Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1312-2026 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. 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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      "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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      "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": "A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.",
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