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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2263-2024.jsonld",
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  "name": "Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps",
  "description": "FDA recall Z-2263-2024 — Zyno Medical LLC is recalling Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps (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": "Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2263-2024/enforcement-record",
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      "name": "FDA recall Z-2263-2024: Zyno Medical LLC is recalling Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps",
      "text": "The FDA logged enforcement record Z-2263-2024: Zyno Medical LLC is voluntarily recalling Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps — reason: Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to the pump when it is unplugged from the AC mains power.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-04. Affected lots/codes: UDI-DI: Z800:   008143771020006 Z800F:   00814371020013 Z800W:  00814371020020 Z800WF: 00814371020037;  Serial Numbers:  Z-800: 905283  Z-800F: 610844 609115 616225 608843 608854 608878 609662 611192 611221 605032 607483 613133 619542 609315 607545 602521 611251 601782 601905 604576 602023 604135 601424 602518 608407 608335 608361 608399 608438 607773 608590 609773 608955 608960 608962 610650 607324 610217 607402 608152 608197 609143 609380 608996 607439 611588 611605 614257 609672 609730 601191 614278 608497 608641 610128 610132 610158 601438 615722 616791 603717 607171 608826 608150 608137 609199 609276 602280 610713 613781 607496 608918 609355 605090 608790 603096 615110  Z-800W: 700568   Z-800WF: 503770 500010 500054 501954 502832 504296 504496 503950 500066. A RECORDED FDA enforcement action (occurred=true).",
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        "supported": true,
        "adjudged": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2263-2024&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-2263-2024&lang=eng"
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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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2263-2024/fda-classification",
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      "name": "FDA classified recall Z-2263-2024 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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2263-2024/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.",
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        "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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            "Field": "Recalling firm",
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            "Field": "Reason",
            "Value": "Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to the pump when it is unplugged from the AC mains power.",
            "Status": "recorded"
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            "Value": "UDI-DI: Z800:   008143771020006 Z800F:   00814371020013 Z800W:  00814371020020 Z800WF: 00814371020037;  Serial Numbers:  Z-800: 905283  Z-800F: 610844 609115 616225 608843 608854 608878 609662 611192 611221 605032 607483 613133 619542 609315 607545 602521 611251 601782 601905 604576 602023 604135 601424 602518 608407 608335 608361 608399 608438 607773 608590 609773 608955 608960 608962 610650 607324 610217 607402 608152 608197 609143 609380 608996 607439 611588 611605 614257 609672 609730 601191 614278 608497 608641 610128 610132 610158 601438 615722 616791 603717 607171 608826 608150 608137 609199 609276 602280 610713 613781 607496 608918 609355 605090 608790 603096 615110  Z-800W: 700568   Z-800WF: 503770 500010 500054 501954 502832 504296 504496 503950 500066",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
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