{ "@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-1477-2025.jsonld", "@type": "schema:Dataset", "name": "Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)", "description": "FDA recall Z-1477-2025 — Stryker Corporation is recalling Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS) (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-1477-2025&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)", "manufacturer": { "@type": "schema:Organization", "name": "Stryker Corporation" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1477-2025/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1477-2025: Stryker Corporation is recalling Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)", "text": "The FDA logged enforcement record Z-1477-2025: Stryker Corporation is voluntarily recalling Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS) — 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: 5400-020-208 UDI-DI: 07613327117233, Lot Numbers: 2022093020 2023011632 2023041321 2023062320 2023092220 2023112232 2024032120 2024052420 2022093021 2023011932 2023042120 2023062220 2023092932 2023112420 2024032820 2024052320 2022100720 2023012732 2023042121 2023073120 2023101220 2023112320 2024032920 2024060620 2022100620 2023013033 2023050320 2023073121 2023101221 2023120120 2024040520 2024060720 2022101320 2023020132 2023050220 2023081520 2023101921 2023113020 2024040420 2024062020 2022101420 2023020632 2023051620 2023081521 2023101920 2023120632 2024041820 2024062120 2022101720 2023022033 2023051720 2023082520 2023102721 2023121533 2024041920 2024070420 2022102120 2023030220 2023052620 2023082521 2023102720 2024010532 2024042632 2024070520 2022102720 2023030320 2023052520 2023083120 2023110320 2024020120 2024042520 2024071538 2022102820 2023032420 2023060120 2023090120 2023110220 2024020220 2024042620 2024071738 2022110220 2023032320 2023060220 2023090820 2023110733 2024030820 2024050821 2022110320 2023032920 2023060820 2023090620 2023110920 2024030720 2024050820 2022112932 2023033020 2023060920 2023091520 2023110921 2024031420 2024051520 2023010433 2023040732 2023061520 2023091420 2023111720 2024031520 2024051721 2023010932 2023041320 2023061620 2023092120 2023111620 2024032220 2024052332 7; 5400-020-208ITL UDI-DI: 07613327602623, Lot Numbers: 2024052333. 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-1477-2025&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-1477-2025&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-1477-2025/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1477-2025 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-1477-2025&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-1477-2025&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-1477-2025/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-1477-2025", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1477-2025", "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": "5400-020-208 UDI-DI: 07613327117233, Lot Numbers: 2022093020 2023011632 2023041321 2023062320 2023092220 2023112232 2024032120 2024052420 2022093021 2023011932 2023042120 2023062220 2023092932 2023112420 2024032820 2024052320 2022100720 2023012732 2023042121 2023073120 2023101220 2023112320 2024032920 2024060620 2022100620 2023013033 2023050320 2023073121 2023101221 2023120120 2024040520 2024060720 2022101320 2023020132 2023050220 2023081520 2023101921 2023113020 2024040420 2024062020 2022101420 2023020632 2023051620 2023081521 2023101920 2023120632 2024041820 2024062120 2022101720 2023022033 2023051720 2023082520 2023102721 2023121533 2024041920 2024070420 2022102120 2023030220 2023052620 2023082521 2023102720 2024010532 2024042632 2024070520 2022102720 2023030320 2023052520 2023083120 2023110320 2024020120 2024042520 2024071538 2022102820 2023032420 2023060120 2023090120 2023110220 2024020220 2024042620 2024071738 2022110220 2023032320 2023060220 2023090820 2023110733 2024030820 2024050821 2022110320 2023032920 2023060820 2023090620 2023110920 2024030720 2024050820 2022112932 2023033020 2023060920 2023091520 2023110921 2024031420 2024051520 2023010433 2023040732 2023061520 2023091420 2023111720 2024031520 2024051721 2023010932 2023041320 2023061620 2023092120 2023111620 2024032220 2024052332 7; 5400-020-208ITL UDI-DI: 07613327602623, Lot Numbers: 2024052333", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "US Nationwide distribution.", "Status": "recorded" } } ] } ] }