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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0444-2026.jsonld",
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  "name": "Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;  OPEN HEART SUPPLEMENT  DYNJ909116D;  VASCULAR  DYNJ909124F",
  "description": "FDA recall Z-0444-2026 — Medline Industries, LP is recalling Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;  OPEN HEART SUPPLEMENT  DYNJ909116D;  VASCULAR  DYNJ909124F (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": "openFDA drug & device enforcement (recall) reports",
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0444-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;  OPEN HEART SUPPLEMENT  DYNJ909116D;  VASCULAR  DYNJ909124F",
    "manufacturer": {
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      "name": "Medline Industries, LP"
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      "name": "FDA recall Z-0444-2026: Medline Industries, LP is recalling Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;  OPEN HEART SUPPLEMENT  DYNJ909116D;  VASCULAR  DYNJ909124F",
      "text": "The FDA logged enforcement record Z-0444-2026: Medline Industries, LP is voluntarily recalling Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;  OPEN HEART SUPPLEMENT  DYNJ909116D;  VASCULAR  DYNJ909124F — reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120\" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-10. Affected lots/codes: DYNJ909116D UDI-DI 40198459055356 (case), 10198459055355 (ea) Lots 25FBM604 25GBP604;  DYNJ909124F UDI-DI 40198459130619 (case), 10198459130618 (ea) Lots 25FBB831 25GBI833. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0444-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0444-2026&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0444-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0444-2026 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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        "value": "Class I",
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0444-2026/boundary",
      "@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",
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      "epistemicStatus": {
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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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      "name": "FDA recall details — Z-0444-2026",
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            "Value": "Z-0444-2026",
            "Status": "recorded"
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
            "Value": "Medline Industries, LP",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120\" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-10-10",
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            "Field": "Lot/code info",
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            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;",
            "Status": "recorded"
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