{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0365-2025.jsonld", "@type": "schema:Dataset", "name": "Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - 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: 0703-047-000", "description": "FDA recall Z-0365-2025 — Stryker Corporation is recalling Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - 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: 0703-047-000 (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, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "dateModified": "2026-06-24T07:02:03.626072+00:00", "isBasedOn": { "@type": "schema:Dataset", "name": "openFDA drug & device enforcement (recall) reports", "url": "https://open.fda.gov/apis/drug/enforcement/", "creator": { "@type": "schema:GovernmentOrganization", "name": "U.S. Food & Drug Administration" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0365-2025&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - 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: 0703-047-000", "manufacturer": { "@type": "schema:Organization", "name": "Stryker Corporation" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0365-2025/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-0365-2025: Stryker Corporation is recalling Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - 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: 0703-047-000", "text": "The FDA logged enforcement record Z-0365-2025: Stryker Corporation is voluntarily recalling Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - 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: 0703-047-000 — 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: UDI-DI: 07613327117202 Lot Numbers: 53863666 54409859 56319954 56945653 57699375 59053479 65178945 53863667 54409860 56319955 56945654 57699376 59053480 65178946 53863668 54409862 56319956 57699353 57699377 59053481 65178947 53863669 54409919 56319957 57699354 57699378 59053482 65178949 53863670 54409920 56319958 57699355 57699379 59053483 65347997 53863671 54409921 56319959 57699359 57699380 61288937 65784636 54403959 54409922 56319960 57699360 57699381 61288943 65784637 54403960 54409923 56319961 57699361 57699382 62825781 65784638 54403961 54409924 56892676 57699362 57805609 64117282 65784639 54403962 54409925 56892677 57699363 57805610 64477143 65876797 54403963 54409926 56892689 57699364 57805611 64477144 65961918 54403964 54409927 56932527 57699365 58320366 64477145 66133414 54403965 54533880 56932528 57699366 58514707 64855504 66275138 54409851 54533881 56932533 57699367 58766534 64855505 V53051139 54409852 54533882 56932534 57699368 58766535 64855515 V53051140 54409853 54533883 56945645 57699369 58766536 64855516 V53267506 54409854 54533884 56945646 57699370 58766539 64973261 V53526100 54409855 54654973 56945647 57699371 58766540 64973262 V53708277 54409856 54665296 56945648 57699372 58791419 64973263 V53708278 54409857 56319952 56945651 57699373 59053477 64973266 V53934891 54409858 56319953 56945652 57699374 59053478 64973267 V53934892 V53934893 Additional Lot Numbers: 64262566 66387346 66599251 66758654 67377504 67652611 67794514 64973268 66387347 66705549 66758655 67377505 67652612 68735135 65178952 66387348 66705550 67017675 67377506 67652613 68735136 65178953 66387349 66758652 67017676 67481713 67794512 68735137 66387345 66599250 66758653 67207470 67652610 67794513 68735138. 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-0365-2025&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-0365-2025&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." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0365-2025/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-0365-2025 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.", "claimType": "regulatory_determination", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "AdjudicativeAct", "source": "U.S. FDA recall classification (openFDA enforcement)", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0365-2025&lang=eng", "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-0365-2025&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-0365-2025/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": { "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": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-0365-2025", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-0365-2025", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class II", "Status": "determination" } }, { "@type": "schema:ListItem", "position": 4, "item": { "Field": "Status", "Value": "Ongoing — the recall is still being carried out.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 5, "item": { "Field": "Recalling firm", "Value": "Stryker Corporation", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "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" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2024-10-04", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "UDI-DI: 07613327117202 Lot Numbers: 53863666 54409859 56319954 56945653 57699375 59053479 65178945 53863667 54409860 56319955 56945654 57699376 59053480 65178946 53863668 54409862 56319956 57699353 57699377 59053481 65178947 53863669 54409919 56319957 57699354 57699378 59053482 65178949 53863670 54409920 56319958 57699355 57699379 59053483 65347997 53863671 54409921 56319959 57699359 57699380 61288937 65784636 54403959 54409922 56319960 57699360 57699381 61288943 65784637 54403960 54409923 56319961 57699361 57699382 62825781 65784638 54403961 54409924 56892676 57699362 57805609 64117282 65784639 54403962 54409925 56892677 57699363 57805610 64477143 65876797 54403963 54409926 56892689 57699364 57805611 64477144 65961918 54403964 54409927 56932527 57699365 58320366 64477145 66133414 54403965 54533880 56932528 57699366 58514707 64855504 66275138 54409851 54533881 56932533 57699367 58766534 64855505 V53051139 54409852 54533882 56932534 57699368 58766535 64855515 V53051140 54409853 54533883 56945645 57699369 58766536 64855516 V53267506 54409854 54533884 56945646 57699370 58766539 64973261 V53526100 54409855 54654973 56945647 57699371 58766540 64973262 V53708277 54409856 54665296 56945648 57699372 58791419 64973263 V53708278 54409857 56319952 56945651 57699373 59053477 64973266 V53934891 54409858 56319953 56945652 57699374 59053478 64973267 V53934892 V53934893 Additional Lot Numbers: 64262566 66387346 66599251 66758654 67377504 67652611 67794514 64973268 66387347 66705549 66758655 67377505 67652612 68735135 65178952 66387348 66705550 67017675 67377506 67652613 68735136 65178953 66387349 66758652 67017676 67481713 67794512 68735137 66387345 66599250 66758653 67207470 67652610 67794513 68735138", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.", "Status": "recorded" } } ] } ] }