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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1325-2025.jsonld",
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  "name": "Brand Name: Da Vinci 5  Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals  Model/Catalog Number: 380730  Software Version: N/A  .     Refer to HHE for additional details.  Component: N/A",
  "description": "FDA recall Z-1325-2025 — Intuitive Surgical, Inc. is recalling Brand Name: Da Vinci 5  Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals  Model/Catalog Number: 380730  Software Version: N/A  .     Refer to HHE for additional details.  Component: N/A (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,
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "creator": {
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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-1325-2025&lang=eng",
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    "name": "Brand Name: Da Vinci 5  Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals  Model/Catalog Number: 380730  Software Version: N/A  .     Refer to HHE for additional details.  Component: N/A",
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      "name": "Intuitive Surgical, Inc."
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      "name": "FDA recall Z-1325-2025: Intuitive Surgical, Inc. is recalling Brand Name: Da Vinci 5  Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals  Model/Catalog Number: 380730  Software Version: N/A  .     Refer to HHE for additional details.  Component: N/A",
      "text": "The FDA logged enforcement record Z-1325-2025: Intuitive Surgical, Inc. is voluntarily recalling Brand Name: Da Vinci 5  Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals  Model/Catalog Number: 380730  Software Version: N/A  .     Refer to HHE for additional details.  Component: N/A — reason: Due to an increase in complaints  concerning foot tray pedal spring failing resulting in the  pedal remaining pressed. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-26. Affected lots/codes: UDI: 00886874119747/  All da Vinci dV5 consoles and foot trays assemblies manufactured prior to 12/20/2024.. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
        "operative": true
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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-1325-2025&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-1325-2025&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."
    },
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1325-2025/fda-classification",
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      "name": "FDA classified recall Z-1325-2025 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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1325-2025/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": {
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        "supported": true,
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        "groundingType": "Interpretation",
        "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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            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Due to an increase in complaints  concerning foot tray pedal spring failing resulting in the  pedal remaining pressed",
            "Status": "recorded"
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            "Value": "2025-02-26",
            "Status": "recorded"
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            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, \tSouth Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, \tWisconsin, Wyoming and the country of South Korea.",
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