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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0366-2025.jsonld",
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  "name": "Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.    Catalog Number: 0703-047-002",
  "description": "FDA recall Z-0366-2025 — Stryker Corporation is recalling Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.    Catalog Number: 0703-047-002 (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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0366-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.    Catalog Number: 0703-047-002",
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      "name": "Stryker Corporation"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0366-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0366-2025: Stryker Corporation is recalling Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.    Catalog Number: 0703-047-002",
      "text": "The FDA logged enforcement record Z-0366-2025: Stryker Corporation is voluntarily recalling Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.    Catalog Number: 0703-047-002 — reason: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents  carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-04. Affected lots/codes: GTIN: 07613327379471 Lot Numbers: 53700305   53864207   53864241   53864247   60308905   62012084   64112630   65342955 53700306   53864212   53864243   53864248   60308906   62291715   64112631   65869470 53700307   53864213   53864244   53864249   60308907   62291717   64142443   65869471 53700308   53864214   53864245   53864257   61283868   62821201   64968515   65954806 53864205   53864219   53864246   60308904   61283869   64112629   64968516   66005707 53864206  Additional Lot Numbers:  64917537 65342956 66487443 67787272 67840867 68672644 64917538 66487442 67787271 67840866 67840868 68672645. 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-0366-2025&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-0366-2025&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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      "name": "FDA classified recall Z-0366-2025 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-0366-2025&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-0366-2025/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",
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      "epistemicStatus": {
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        "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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            "Value": "Z-0366-2025",
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            "Value": "Devices",
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          "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,
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            "Field": "Recalling firm",
            "Value": "Stryker Corporation",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents  carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-10-04",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "GTIN: 07613327379471 Lot Numbers: 53700305   53864207   53864241   53864247   60308905   62012084   64112630   65342955 53700306   53864212   53864243   53864248   60308906   62291715   64112631   65869470 53700307   53864213   53864244   53864249   60308907   62291717   64142443   65869471 53700308   53864214   53864245   53864257   61283868   62821201   64968515   65954806 53864205   53864219   53864246   60308904   61283869   64112629   64968516   66005707 53864206  Additional Lot Numbers:  64917537 65342956 66487443 67787272 67840867 68672644 64917538 66487442 67787271 67840866 67840868 68672645",
            "Status": "recorded"
          }
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.",
            "Status": "recorded"
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