{ "@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-1470-2025.jsonld", "@type": "schema:Dataset", "name": "Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL", "description": "FDA recall Z-1470-2025 — Stryker Corporation is recalling Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL (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-1470-2025&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL", "manufacturer": { "@type": "schema:Organization", "name": "Stryker Corporation" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1470-2025/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1470-2025: Stryker Corporation is recalling Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL", "text": "The FDA logged enforcement record Z-1470-2025: Stryker Corporation is voluntarily recalling Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL — reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-25. Affected lots/codes: 5400-010-004 UDI-DI: 07613154340798, Lot Numbers: 2022101814 2023021412 2023082413 2024022915 2022111414 2023051712 2023090114 2022102413 2023022133 2023090613 2024031915 2023011013 2023052415 2023110315 2022111413 2023050913 2023091912 2024032215 2023011913 2023061615 2023112314 2023011613 2023051213 2023103115 2024040214 2023020113 2023062132 2024011912 2023012413 2023071713 2023110812 2024052915 2023020333 2023062615 2024020813 2023012713 2023080812 2023112018 2024062412 2023020612 2023062915 2024080117 2023020912 2023081112 2024011613 2024080912 2023050414 2023070433 2024082216; 5400-010-004ITL UDI-DI: 07613327359435, Lot Numbers: 2022111414 2023051712 2023090114 2023011013 2023052415 2023110315 2023011913 2023061615 2023112314 2023020113 2023062132 2024011912 2023020333 2023062615 2024020813 2023020612 2023062915 2024080117 2023050414 2023070433 2024082216. 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-1470-2025&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-1470-2025&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-1470-2025/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1470-2025 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-1470-2025&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-1470-2025&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-1470-2025/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-1470-2025", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1470-2025", "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 blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-02-25", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "5400-010-004 UDI-DI: 07613154340798, Lot Numbers: 2022101814 2023021412 2023082413 2024022915 2022111414 2023051712 2023090114 2022102413 2023022133 2023090613 2024031915 2023011013 2023052415 2023110315 2022111413 2023050913 2023091912 2024032215 2023011913 2023061615 2023112314 2023011613 2023051213 2023103115 2024040214 2023020113 2023062132 2024011912 2023012413 2023071713 2023110812 2024052915 2023020333 2023062615 2024020813 2023012713 2023080812 2023112018 2024062412 2023020612 2023062915 2024080117 2023020912 2023081112 2024011613 2024080912 2023050414 2023070433 2024082216; 5400-010-004ITL UDI-DI: 07613327359435, Lot Numbers: 2022111414 2023051712 2023090114 2023011013 2023052415 2023110315 2023011913 2023061615 2023112314 2023020113 2023062132 2024011912 2023020333 2023062615 2024020813 2023020612 2023062915 2024080117 2023050414 2023070433 2024082216", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "US Nationwide distribution.", "Status": "recorded" } } ] } ] }