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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0368-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Various models of  BD Pyxis MedFlex, Reference numbers: 1119-00  1139-00  139038-01  139039-01  139040-01  139041-01  139043-01  139044-01  139045-01  139046-01  139049-01  139051-01  139052-01  139053-01  139054-01  139055-01  139056-01  139058-01  139059-01  139060-01  139061-01  139064-01  139065-01  139066-01  139067-01  139068-01  139069-01  139070-01  139071-01  139072-01  139164-01  139165-01  300",
  "description": "FDA recall Z-0368-2026 — CareFusion 303, Inc. is recalling Various models of  BD Pyxis MedFlex, Reference numbers: 1119-00  1139-00  139038-01  139039-01  139040-01  139041-01  139043-01  139044-01  139045-01  139046-01  139049-01  139051-01  139052-01  139053-01  139054-01  139055-01  139056-01  139058-01  139059-01  139060-01  139061-01  139064-01  139065-01  139066-01  139067-01  139068-01  139069-01  139070-01  139071-01  139072-01  139164-01  139165-01  300 (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0368-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Various models of  BD Pyxis MedFlex, Reference numbers: 1119-00  1139-00  139038-01  139039-01  139040-01  139041-01  139043-01  139044-01  139045-01  139046-01  139049-01  139051-01  139052-01  139053-01  139054-01  139055-01  139056-01  139058-01  139059-01  139060-01  139061-01  139064-01  139065-01  139066-01  139067-01  139068-01  139069-01  139070-01  139071-01  139072-01  139164-01  139165-01  300",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "CareFusion 303, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0368-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0368-2026: CareFusion 303, Inc. is recalling Various models of  BD Pyxis MedFlex, Reference numbers: 1119-00  1139-00  139038-01  139039-01  139040-01  139041-01  139043-01  139044-01  139045-01  139046-01  139049-01  139051-01  139052-01  139053-01  139054-01  139055-01  139056-01  139058-01  139059-01  139060-01  139061-01  139064-01  139065-01  139066-01  139067-01  139068-01  139069-01  139070-01  139071-01  139072-01  139164-01  139165-01  300",
      "text": "The FDA logged enforcement record Z-0368-2026: CareFusion 303, Inc. is voluntarily recalling Various models of  BD Pyxis MedFlex, Reference numbers: 1119-00  1139-00  139038-01  139039-01  139040-01  139041-01  139043-01  139044-01  139045-01  139046-01  139049-01  139051-01  139052-01  139053-01  139054-01  139055-01  139056-01  139058-01  139059-01  139060-01  139061-01  139064-01  139065-01  139066-01  139067-01  139068-01  139069-01  139070-01  139071-01  139072-01  139164-01  139165-01  300 — reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-30. Affected lots/codes: All Serial Numbers/Ref #/UDI: 1119-00 10885403512704, 1139-00 10885403512704, 139038-01 N/A, 139039-01 N/A, 139040-01 N/A, 139041-01 N/A, 139043-01 N/A, 139044-01 N/A, 139045-01 N/A, 139046-01 N/A, 139049-01 N/A, 139051-01 N/A, 139052-01 N/A, 139053-01 N/A, 139054-01 N/A, 139055-01 N/A, 139056-01 N/A, 139058-01 N/A, 139059-01 N/A, 139060-01 N/A, 139061-01 N/A, 139064-01 N/A, 139065-01 N/A, 139066-01 N/A, 139067-01 N/A, 139068-01 N/A, 139069-01 N/A, 139070-01 N/A, 139071-01 N/A, 139072-01 N/A, 139164-01 N/A, 139165-01 N/A, 300 N/A. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "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-0368-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "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-0368-2026&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-0368-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0368-2026 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0368-2026&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0368-2026&lang=eng"
        }
      },
      "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-0368-2026/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",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0368-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0368-2026",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "CareFusion 303, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-09-30",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "All Serial Numbers/Ref #/UDI: 1119-00 10885403512704, 1139-00 10885403512704, 139038-01 N/A, 139039-01 N/A, 139040-01 N/A, 139041-01 N/A, 139043-01 N/A, 139044-01 N/A, 139045-01 N/A, 139046-01 N/A, 139049-01 N/A, 139051-01 N/A, 139052-01 N/A, 139053-01 N/A, 139054-01 N/A, 139055-01 N/A, 139056-01 N/A, 139058-01 N/A, 139059-01 N/A, 139060-01 N/A, 139061-01 N/A, 139064-01 N/A, 139065-01 N/A, 139066-01 N/A, 139067-01 N/A, 139068-01 N/A, 139069-01 N/A, 139070-01 N/A, 139071-01 N/A, 139072-01 N/A, 139164-01 N/A, 139165-01 N/A, 300 N/A",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}