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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1466-2025.jsonld",
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  "name": "Brand Name: Checkpoint Guardian Intraoperative Lead  Product Name: Checkpoint Guardian Intraoperative Lead, Small  Model/Catalog Number: REF# 9524 (Small)  Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for  providing stimulus to a targeted nerve. The accessories are intended for use with any device from  the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves  that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a  targeted nerve.",
  "description": "FDA recall Z-1466-2025 — Checkpoint Surgical Inc is recalling Brand Name: Checkpoint Guardian Intraoperative Lead  Product Name: Checkpoint Guardian Intraoperative Lead, Small  Model/Catalog Number: REF# 9524 (Small)  Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for  providing stimulus to a targeted nerve. The accessories are intended for use with any device from  the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves  that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a  targeted nerve. (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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      "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-1466-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Checkpoint Guardian Intraoperative Lead  Product Name: Checkpoint Guardian Intraoperative Lead, Small  Model/Catalog Number: REF# 9524 (Small)  Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for  providing stimulus to a targeted nerve. The accessories are intended for use with any device from  the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves  that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a  targeted nerve.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Checkpoint Surgical Inc"
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  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1466-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1466-2025: Checkpoint Surgical Inc is recalling Brand Name: Checkpoint Guardian Intraoperative Lead  Product Name: Checkpoint Guardian Intraoperative Lead, Small  Model/Catalog Number: REF# 9524 (Small)  Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for  providing stimulus to a targeted nerve. The accessories are intended for use with any device from  the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves  that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a  targeted nerve.",
      "text": "The FDA logged enforcement record Z-1466-2025: Checkpoint Surgical Inc is voluntarily recalling Brand Name: Checkpoint Guardian Intraoperative Lead  Product Name: Checkpoint Guardian Intraoperative Lead, Small  Model/Catalog Number: REF# 9524 (Small)  Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for  providing stimulus to a targeted nerve. The accessories are intended for use with any device from  the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves  that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a  targeted nerve. — reason: Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-24. Affected lots/codes: UDI-DI B13095240 Small Lot 4318 Expires 01Apr2026 Lot 4325 Expires 01Apr2026 Lot 4368 Expires 01Dec2026. 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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      "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-1466-2025&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-1466-2025&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-1466-2025/fda-classification",
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      "name": "FDA classified recall Z-1466-2025 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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        "adjudged": true,
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-1466-2025&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-1466-2025/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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      "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."
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            "Value": "Z-1466-2025",
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            "Value": "Devices",
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            "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,
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            "Field": "Recalling firm",
            "Value": "Checkpoint Surgical Inc",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.",
            "Status": "recorded"
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            "Field": "Initiated",
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            "Value": "UDI-DI B13095240 Small Lot 4318 Expires 01Apr2026 Lot 4325 Expires 01Apr2026 Lot 4368 Expires 01Dec2026",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
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