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  "name": "MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C",
  "description": "FDA recall Z-0886-2026 — Medline Industries, LP is recalling MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C (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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      "name": "FDA recall Z-0886-2026: Medline Industries, LP is recalling MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C",
      "text": "The FDA logged enforcement record Z-0886-2026: Medline Industries, LP is voluntarily recalling MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C — reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-27. Affected lots/codes: UDI/DI 10193489621532 (each) 40193489621533 (case), Lot Number 25FMJ081. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0886-2026 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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      "@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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      "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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