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  "name": "Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS",
  "description": "FDA recall Z-1423-2025 — Baxter Healthcare Corporation is recalling Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS (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": "Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1423-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1423-2025: Baxter Healthcare Corporation is recalling Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS",
      "text": "The FDA logged enforcement record Z-1423-2025: Baxter Healthcare Corporation is voluntarily recalling Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS — reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-03. Affected lots/codes: UDI/DI 05413765852428, Serial Numbers:  02A220600103, 02A221100387, 02A240800201, 02A230300471, 02A240800161, 02A220600112, 02A230100474, 02A240800343, 02A230400357, 02A240800175, 02A220700259, 02A230200471, 02A240800710, 02A230600165, 02A240800223, 02A220700176, 02A230200487, 02A240900081, 02A230600175, 02A240800513, 02A220700349, 02A230300030, 02A240900133, 02A230600176, 02A240800577, 02A220700268, 02A230300117, 02A240900265, 02A230600255, 02A240900261, 02A220700081, 02A230300125, 02A240900277, 02A230600256, 02A240900421, 02A220700140, 02A230300132, 02A240900285, 02A230600618, 02A240900742, 02A220700351, 02A230300146, 02A240900287, 02A230700137, 02A240900746, 02A220700409, 02A230300275, 02A240900282, 02A241000576, 02A240901067, 02A220700368, 02A230300287, 02A240900373, 02A220700166, 02A240901181, 02A220700428, 02A230300309, 02A240900407, 02A221000108, 02A240901422, 02A220700450, 02A230300350, 02A240900422, 02A221000346, 02A240901428, 02A220700454, 02A230300389, 02A240900423, 02A221000349, 02A240901430, 02A220700458, 02A230300477, 02A240900443, 02A221100154, 02A241000027, 02A220800010, 02A230300520, 02A240900427, 02A221100208, 02A241000051, 02A220800060, 02A230300547, 02A240900502, 02A221100201, 02A241000251, 02A220800201, 02A230400035, 02A240900681, 02A230200462, 02A241000254, 02A220800407, 02A230400145, 02A240900677, 02A230200495, 02A241000366, 02A221000109, 02A230600421, 02A240900749, 02A230300091, 02A241000479, 02A221000233, 02A230600549, 02A240900811, 02A230300342, 02A241000862, 02A221000240, 02A230600792, 02A240900981, 02A230300367, 02A241001284, 02A221000360, 02A230600820, 02A240901095, 02A230300417, 02A241001392, 02A221000099, 02A230600894, 02A240901196, 02A230300533, 02A241001413, 02A221100056, 02A230600908, 02A240901243, 02A230400030, 02A241001478, 02A221100116, 02A230700053, 02A241000498, 02A230600496, 02A241001496, 02A221100244, 02A230700043, 02A241000939, 02A240800026, 02A241100021, 02A221100260, 02A240600468, 02A241000957, 02A240800050, 02A241100037, 02A221100294, 02A240800006, 02A230300466, 02A240800069, 02A241100047, 02A221100346, 02A240800007, 02A230300467, 02A240800142.. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1423-2025&lang=eng",
        "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-1423-2025 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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      "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",
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      "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": "Baxter Healthcare Corporation",
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            "Field": "Reason",
            "Value": "Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of AR, CA, FL, IA, IN, LA, MO, MT, NC, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV.",
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