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  "name": "Baxter Vascular Probe, Product Codes:    a)\t7081015:  8CM, 1- 1.5 MM GLOBAL,    b)\t7081520:  8CM, 1.5-2 MM GLOBAL,    c)\t7082025:  8CM, 2-2.5 MM GLOBAL,    d)\t7151015:  15CM, 1-1.5 MM GLOBAL,    e)\t7151520:  15CM, 1.5- 2 MM GLOBAL,    f)\t7152025:  15CM, 2- 2.5 MM GLOBAL,    g)\t7451015:  45CM, 1- 1.5 MM GLOBAL,    h)\t7451520:  45CM, 1.5- 2 MM GLOBAL,    i)\t7452025:  45CM, 2- 2.5 MM GLOBAL,    j)\t7081015ES:  8CM, 1-1.5 MM GLOBAL,    k)\t7081520ES:   8CM, 1.5- 2 MM GLOBAL,    l)\t7082025ES:   8CM, 2-2.5 MM GLOBAL,    m)\t7151015ES:   15CM, 1-1.5 MM GLOBAL,    n)\t7151520ES:   15CM, 1.5- 2 MM GLOBAL,    o)\t7152025ES:   15CM, 2-2.5 MM GLOBAL,    p)\t7451015ES:   45CM, 1-1.5 MM GLOBAL,    q)\t7451520ES:   45CM, 1.5-2 MM GLOBAL,    r)\t7452025ES:   45CM, 2-2.5 MM GLOBAL",
  "description": "FDA recall Z-0659-2024 — Baxter Healthcare Corporation is recalling Baxter Vascular Probe, Product Codes:    a)\t7081015:  8CM, 1- 1.5 MM GLOBAL,    b)\t7081520:  8CM, 1.5-2 MM GLOBAL,    c)\t7082025:  8CM, 2-2.5 MM GLOBAL,    d)\t7151015:  15CM, 1-1.5 MM GLOBAL,    e)\t7151520:  15CM, 1.5- 2 MM GLOBAL,    f)\t7152025:  15CM, 2- 2.5 MM GLOBAL,    g)\t7451015:  45CM, 1- 1.5 MM GLOBAL,    h)\t7451520:  45CM, 1.5- 2 MM GLOBAL,    i)\t7452025:  45CM, 2- 2.5 MM GLOBAL,    j)\t7081015ES:  8CM, 1-1.5 MM GLOBAL,    k)\t7081520ES:   8CM, 1.5- 2 MM GLOBAL,    l)\t7082025ES:   8CM, 2-2.5 MM GLOBAL,    m)\t7151015ES:   15CM, 1-1.5 MM GLOBAL,    n)\t7151520ES:   15CM, 1.5- 2 MM GLOBAL,    o)\t7152025ES:   15CM, 2-2.5 MM GLOBAL,    p)\t7451015ES:   45CM, 1-1.5 MM GLOBAL,    q)\t7451520ES:   45CM, 1.5-2 MM GLOBAL,    r)\t7452025ES:   45CM, 2-2.5 MM GLOBAL (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": "openFDA drug & device enforcement (recall) reports",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Baxter Vascular Probe, Product Codes:    a)\t7081015:  8CM, 1- 1.5 MM GLOBAL,    b)\t7081520:  8CM, 1.5-2 MM GLOBAL,    c)\t7082025:  8CM, 2-2.5 MM GLOBAL,    d)\t7151015:  15CM, 1-1.5 MM GLOBAL,    e)\t7151520:  15CM, 1.5- 2 MM GLOBAL,    f)\t7152025:  15CM, 2- 2.5 MM GLOBAL,    g)\t7451015:  45CM, 1- 1.5 MM GLOBAL,    h)\t7451520:  45CM, 1.5- 2 MM GLOBAL,    i)\t7452025:  45CM, 2- 2.5 MM GLOBAL,    j)\t7081015ES:  8CM, 1-1.5 MM GLOBAL,    k)\t7081520ES:   8CM, 1.5- 2 MM GLOBAL,    l)\t7082025ES:   8CM, 2-2.5 MM GLOBAL,    m)\t7151015ES:   15CM, 1-1.5 MM GLOBAL,    n)\t7151520ES:   15CM, 1.5- 2 MM GLOBAL,    o)\t7152025ES:   15CM, 2-2.5 MM GLOBAL,    p)\t7451015ES:   45CM, 1-1.5 MM GLOBAL,    q)\t7451520ES:   45CM, 1.5-2 MM GLOBAL,    r)\t7452025ES:   45CM, 2-2.5 MM GLOBAL",
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      "name": "Baxter Healthcare Corporation"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0659-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0659-2024: Baxter Healthcare Corporation is recalling Baxter Vascular Probe, Product Codes:    a)\t7081015:  8CM, 1- 1.5 MM GLOBAL,    b)\t7081520:  8CM, 1.5-2 MM GLOBAL,    c)\t7082025:  8CM, 2-2.5 MM GLOBAL,    d)\t7151015:  15CM, 1-1.5 MM GLOBAL,    e)\t7151520:  15CM, 1.5- 2 MM GLOBAL,    f)\t7152025:  15CM, 2- 2.5 MM GLOBAL,    g)\t7451015:  45CM, 1- 1.5 MM GLOBAL,    h)\t7451520:  45CM, 1.5- 2 MM GLOBAL,    i)\t7452025:  45CM, 2- 2.5 MM GLOBAL,    j)\t7081015ES:  8CM, 1-1.5 MM GLOBAL,    k)\t7081520ES:   8CM, 1.5- 2 MM GLOBAL,    l)\t7082025ES:   8CM, 2-2.5 MM GLOBAL,    m)\t7151015ES:   15CM, 1-1.5 MM GLOBAL,    n)\t7151520ES:   15CM, 1.5- 2 MM GLOBAL,    o)\t7152025ES:   15CM, 2-2.5 MM GLOBAL,    p)\t7451015ES:   45CM, 1-1.5 MM GLOBAL,    q)\t7451520ES:   45CM, 1.5-2 MM GLOBAL,    r)\t7452025ES:   45CM, 2-2.5 MM GLOBAL",
      "text": "The FDA logged enforcement record Z-0659-2024: Baxter Healthcare Corporation is voluntarily recalling Baxter Vascular Probe, Product Codes:    a)\t7081015:  8CM, 1- 1.5 MM GLOBAL,    b)\t7081520:  8CM, 1.5-2 MM GLOBAL,    c)\t7082025:  8CM, 2-2.5 MM GLOBAL,    d)\t7151015:  15CM, 1-1.5 MM GLOBAL,    e)\t7151520:  15CM, 1.5- 2 MM GLOBAL,    f)\t7152025:  15CM, 2- 2.5 MM GLOBAL,    g)\t7451015:  45CM, 1- 1.5 MM GLOBAL,    h)\t7451520:  45CM, 1.5- 2 MM GLOBAL,    i)\t7452025:  45CM, 2- 2.5 MM GLOBAL,    j)\t7081015ES:  8CM, 1-1.5 MM GLOBAL,    k)\t7081520ES:   8CM, 1.5- 2 MM GLOBAL,    l)\t7082025ES:   8CM, 2-2.5 MM GLOBAL,    m)\t7151015ES:   15CM, 1-1.5 MM GLOBAL,    n)\t7151520ES:   15CM, 1.5- 2 MM GLOBAL,    o)\t7152025ES:   15CM, 2-2.5 MM GLOBAL,    p)\t7451015ES:   45CM, 1-1.5 MM GLOBAL,    q)\t7451520ES:   45CM, 1.5-2 MM GLOBAL,    r)\t7452025ES:   45CM, 2-2.5 MM GLOBAL — reason: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products\u0019 Instructions for Use (IFU) or Prescribing Information (PI).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-06. Affected lots/codes: a) 7081015: UDI/DI 0338-9564-17,  b) 7081520: UDI/DI 0338-9564-18,  c) 7082025: UDI/DI 0338-9564-19,  d) 7151015: UDI/DI 0338-9564-12,  e) 7151520: UDI/DI 0338-9564-11,  f) 7152025: UDI/DI 0338-9564-13,  g) 7451015: UDI/DI 0338-9564-14,  h) 7451520: UDI/DI 0338-9564-15,  i) 7452025: UDI/DI 0338-9564-16,  j) 7081015ES: UDI/DI 0338-9564-10,  k) 7081520ES: UDI/DI 0338-9564-26,  l) 7082025ES: UDI/DI 0338-9564-27,  m) 7151015ES: UDI/DI 0338-9564-21,  n) 7151520ES: UDI/DI 0338-9564-20,  o) 7152025ES: UDI/DI 0338-9564-22,  p) 7451015ES: UDI/DI 0338-9564-24,  q) 7451520ES: UDI/DI 0338-9564-23,  r) 7452025ES: UDI/DI 0338-9564-25,   All serial numbers. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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        "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-0659-2024&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-0659-2024&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0659-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0659-2024 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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-0659-2024/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.",
      "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": [
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      "name": "FDA recall details — Z-0659-2024",
      "numberOfItems": 9,
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            "Field": "Recall number",
            "Value": "Z-0659-2024",
            "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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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Baxter Healthcare Corporation",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products\u0019 Instructions for Use (IFU) or Prescribing Information (PI).",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-12-06",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) 7081015: UDI/DI 0338-9564-17,  b) 7081520: UDI/DI 0338-9564-18,  c) 7082025: UDI/DI 0338-9564-19,  d) 7151015: UDI/DI 0338-9564-12,  e) 7151520: UDI/DI 0338-9564-11,  f) 7152025: UDI/DI 0338-9564-13,  g) 7451015: UDI/DI 0338-9564-14,  h) 7451520: UDI/DI 0338-9564-15,  i) 7452025: UDI/DI 0338-9564-16,  j) 7081015ES: UDI/DI 0338-9564-10,  k) 7081520ES: UDI/DI 0338-9564-26,  l) 7082025ES: UDI/DI 0338-9564-27,  m) 7151015ES: UDI/DI 0338-9564-21,  n) 7151520ES: UDI/DI 0338-9564-20,  o) 7152025ES: UDI/DI 0338-9564-22,  p) 7451015ES: UDI/DI 0338-9564-24,  q) 7451520ES: UDI/DI 0338-9564-23,  r) 7452025ES: UDI/DI 0338-9564-25,   All serial numbers",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
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}