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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0601-2026.jsonld",
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  "name": "NICO BrainPath;  Product Number/Product Name    NN-8024  BrainPath Shephard's Hook - Greenberg;  NN-8025  BrainPath Shephard's Hook - Sugita;  NN-8026  BrainPath Shephard's Hook - Budde;  NN-8042  BrainPath Shephard's Hook - Greenberg LK;",
  "description": "FDA recall Z-0601-2026 — Stryker Corporation is recalling NICO BrainPath;  Product Number/Product Name    NN-8024  BrainPath Shephard's Hook - Greenberg;  NN-8025  BrainPath Shephard's Hook - Sugita;  NN-8026  BrainPath Shephard's Hook - Budde;  NN-8042  BrainPath Shephard's Hook - Greenberg LK; (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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    "name": "NICO BrainPath;  Product Number/Product Name    NN-8024  BrainPath Shephard's Hook - Greenberg;  NN-8025  BrainPath Shephard's Hook - Sugita;  NN-8026  BrainPath Shephard's Hook - Budde;  NN-8042  BrainPath Shephard's Hook - Greenberg LK;",
    "manufacturer": {
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      "name": "Stryker Corporation"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0601-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0601-2026: Stryker Corporation is recalling NICO BrainPath;  Product Number/Product Name    NN-8024  BrainPath Shephard's Hook - Greenberg;  NN-8025  BrainPath Shephard's Hook - Sugita;  NN-8026  BrainPath Shephard's Hook - Budde;  NN-8042  BrainPath Shephard's Hook - Greenberg LK;",
      "text": "The FDA logged enforcement record Z-0601-2026: Stryker Corporation is voluntarily recalling NICO BrainPath;  Product Number/Product Name    NN-8024  BrainPath Shephard's Hook - Greenberg;  NN-8025  BrainPath Shephard's Hook - Sugita;  NN-8026  BrainPath Shephard's Hook - Budde;  NN-8042  BrainPath Shephard's Hook - Greenberg LK; — reason: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-31. Affected lots/codes: Product Number/UDI-DI (GTIN)/Lot Numbers:   NN-8024 00816744028244  37AI2944 37AJ2013 37BD3753 37BD3778 37CA1605 37CB3738 37CH0636 37CI1919 37EH0405 37FC3059 37FD0154 37GA4512 37GH1715 37GI0110 37GJ1623 37HB0029 37HH2313 37HI1536 37HI1631 37IA7694 37ID4162 37IG2900 37JB1413 37JH0131 37JH2903 37KG1406 37KH2953 37LA0708 37LG1834;  NN-8025 00816744028251  37BB2326 37BJ1836 37CH0640 37DC0545 37HD2766 37KB3677 37KJ1139;  NN-8026 00816744028268  37BJ1837 37CC7852 37CH0643 37DJ1056;  NN-8042 07613327663280  37CC9220 37ED9408 37FJ2202 37II2308 37LD8666. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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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-0601-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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      "name": "FDA classified recall Z-0601-2026 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.",
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        "adjudged": true,
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        "value": "Class II",
        "adjudicator": {
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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-0601-2026/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.",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
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      "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-0601-2026",
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            "Value": "Devices",
            "Status": "recorded"
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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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            "Field": "Recalling firm",
            "Value": "Stryker Corporation",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-10-31",
            "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 Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.",
            "Status": "recorded"
          }
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}