{ "@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-0424-2024.jsonld", "@type": "schema:Dataset", "name": "ProCuity bed series, model number 3009, item number: 300900000000,", "description": "FDA recall Z-0424-2024 — Stryker Medical Division of Stryker Corporation is recalling ProCuity bed series, model number 3009, item number: 300900000000, (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-0424-2024&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "ProCuity bed series, model number 3009, item number: 300900000000,", "manufacturer": { "@type": "schema:Organization", "name": "Stryker Medical Division of Stryker Corporation" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0424-2024/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-0424-2024: Stryker Medical Division of Stryker Corporation is recalling ProCuity bed series, model number 3009, item number: 300900000000,", "text": "The FDA logged enforcement record Z-0424-2024: Stryker Medical Division of Stryker Corporation is voluntarily recalling ProCuity bed series, model number 3009, item number: 300900000000, — reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-08-30. Affected lots/codes: UDI-DI (GTIN): 07613327512656. Serial numbers: 2207000698, 2207000676, 2207000619, 2206001100, 2206001090, 2206001089, 2206001086, 2206001084, 2208001745, 2208001734, 2208001725, 2208001724, 2208000397, 2208000394, 2208000032, 2209002157, 2209002158, 2209002165, 2210000711 , 2210000721 , 2210000723 , 2111000494 , 2206001248 , 2206001250 , 2206001265 , 2206001273 , 2206001317 , 2207000023 , 2207000078 , 2207000303 , 2207000307 , 2207000342 , 2207000350 , 2207000353 , 2207000358 , 2110002355 , 2108002264 , 2209000269 , 2106002756 , 2103001270 , 2109000898 , 2109001004 , 2108001784 , 2107001856 , 2208000874 , 2208000873 , 2208000814 , 2208000805 , 2104001582 , 2104003135 , 2104003758 , 2104003772 , 2104003778 , 2104003786 , 2104003798 , 2104004415 , 2104004431 , 2104004441 , 2104004491 , 2104004537 , 2104004993 , 2104004997 , 2104004998 , 2104005012 , 2104005013 , 2105000649 , 2105000657 , 2105001594 , 2105001621 , 2107000100 , 2107000102 , 2208000795 , 2108000833 , 2211004443, 2211004441, 2211004293, 2211004095 , 2211004050 , 2211003541 , 2209002035 , 2205000370 , 2208001249 , 2208001250 , 2202001692 , 2108002072 , 2108002161 , 2202001958 , 2202002003 , 2205000361 , 2109001797 , 2208001175 , 2208001162 , 2208001044 , 2107001827 , 2208000995 , 2208000992 , 2208000980 , 2208000910 , 2208000854 , 2201001114 , 2208001148 , 2208001129 , 2207001981 , 2106001072 , 2206001367 , 2209002143 , 2208000569 , 2208000568 , 2208000507 , 2208000473 , 2109002479 , 2210002762 , 2112002175 , 2112001663 , 2112000049 , 2106002744 , 2109003074 , 2110000077 , 2110000082 , 2105000094 , 2105004609 , 2108000595 , 2104000805 , 2108001834 , 2108001836 , 2208000577 , 2208000496 , 2201000319 , 2203002461 , 2108002656 , 2203001282 , 2109001070 , 2209002133 , 2112002188 , 2112001020 , 2211000729 , 2109002517 , 2103003835 , 2104000245 , 2207001763 , 2107000933 , 2102000258 , 2110000967 , 2110000965 , 2103000446 , 2108002753 , 2108002726 , 2108002685 , 2108002683 , 2108002673 , 2108002556 , 2108002533 , 2108002507 , 2105002810 , 2112000853 , 2105002764 , 2107000759 , 2209000686 , 2108001946 , 2108001932 , 2112001628 , 2111000528 , 2110001582 , 2111000399 , 2111000286 , 2111000092 , 2111001950 , 2110002881 , 2110002369 , 2207000860 , 2207000862 , 2109002846 , 2110002291 , 2110001555 , 2110001362 , 2108002306 , 2201000283 , 2108001939 , 2107001826 , 2210000028 , 2210000004 , 2111000392 , 2110002880 , 2110002867 , 2110000448 , 2110000458 , 2110002828 , 2110002819 , 2110002405 , 2110002399 , 2110001809 , 2101002085 , 2109002376 , 2110001384 , 2110002668 , 2111000409 , 2111000533 , 2112000343 , 2112000347 , 2109002824 , 2209002123 , 2208000334 , 2208000331 , 2107000836 , 2212000241 , 2212000236, 2212000223, 2212000217 , 2212000215 , 2208000075 , 2201000857 , 2108001491 , 2108001490 , 2108000825 , 2009000613 , 2106001220 , 2106001200 , 2106001197 , 2104001603 , 2201000196 , 2208001930 , 2208001924 , 2208001886 , 2210002945 , 2208001860 , 2111000090 , 2107001825 , 2109002592 , 2107000127 , 2107000115 , 2105002209 , 2205000426 , 2107001697 , 2202001129 , 2105002197 , 2105002192. 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-0424-2024&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-0424-2024&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-0424-2024/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-0424-2024 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-0424-2024&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-0424-2024&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-0424-2024/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-0424-2024", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-0424-2024", "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 Medical Division of Stryker Corporation", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2023-08-30", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "UDI-DI (GTIN): 07613327512656. Serial numbers: 2207000698, 2207000676, 2207000619, 2206001100, 2206001090, 2206001089, 2206001086, 2206001084, 2208001745, 2208001734, 2208001725, 2208001724, 2208000397, 2208000394, 2208000032, 2209002157, 2209002158, 2209002165, 2210000711 , 2210000721 , 2210000723 , 2111000494 , 2206001248 , 2206001250 , 2206001265 , 2206001273 , 2206001317 , 2207000023 , 2207000078 , 2207000303 , 2207000307 , 2207000342 , 2207000350 , 2207000353 , 2207000358 , 2110002355 , 2108002264 , 2209000269 , 2106002756 , 2103001270 , 2109000898 , 2109001004 , 2108001784 , 2107001856 , 2208000874 , 2208000873 , 2208000814 , 2208000805 , 2104001582 , 2104003135 , 2104003758 , 2104003772 , 2104003778 , 2104003786 , 2104003798 , 2104004415 , 2104004431 , 2104004441 , 2104004491 , 2104004537 , 2104004993 , 2104004997 , 2104004998 , 2104005012 , 2104005013 , 2105000649 , 2105000657 , 2105001594 , 2105001621 , 2107000100 , 2107000102 , 2208000795 , 2108000833 , 2211004443, 2211004441, 2211004293, 2211004095 , 2211004050 , 2211003541 , 2209002035 , 2205000370 , 2208001249 , 2208001250 , 2202001692 , 2108002072 , 2108002161 , 2202001958 , 2202002003 , 2205000361 , 2109001797 , 2208001175 , 2208001162 , 2208001044 , 2107001827 , 2208000995 , 2208000992 , 2208000980 , 2208000910 , 2208000854 , 2201001114 , 2208001148 , 2208001129 , 2207001981 , 2106001072 , 2206001367 , 2209002143 , 2208000569 , 2208000568 , 2208000507 , 2208000473 , 2109002479 , 2210002762 , 2112002175 , 2112001663 , 2112000049 , 2106002744 , 2109003074 , 2110000077 , 2110000082 , 2105000094 , 2105004609 , 2108000595 , 2104000805 , 2108001834 , 2108001836 , 2208000577 , 2208000496 , 2201000319 , 2203002461 , 2108002656 , 2203001282 , 2109001070 , 2209002133 , 2112002188 , 2112001020 , 2211000729 , 2109002517 , 2103003835 , 2104000245 , 2207001763 , 2107000933 , 2102000258 , 2110000967 , 2110000965 , 2103000446 , 2108002753 , 2108002726 , 2108002685 , 2108002683 , 2108002673 , 2108002556 , 2108002533 , 2108002507 , 2105002810 , 2112000853 , 2105002764 , 2107000759 , 2209000686 , 2108001946 , 2108001932 , 2112001628 , 2111000528 , 2110001582 , 2111000399 , 2111000286 , 2111000092 , 2111001950 , 2110002881 , 2110002369 , 2207000860 , 2207000862 , 2109002846 , 2110002291 , 2110001555 , 2110001362 , 2108002306 , 2201000283 , 2108001939 , 2107001826 , 2210000028 , 2210000004 , 2111000392 , 2110002880 , 2110002867 , 2110000448 , 2110000458 , 2110002828 , 2110002819 , 2110002405 , 2110002399 , 2110001809 , 2101002085 , 2109002376 , 2110001384 , 2110002668 , 2111000409 , 2111000533 , 2112000343 , 2112000347 , 2109002824 , 2209002123 , 2208000334 , 2208000331 , 2107000836 , 2212000241 , 2212000236, 2212000223, 2212000217 , 2212000215 , 2208000075 , 2201000857 , 2108001491 , 2108001490 , 2108000825 , 2009000613 , 2106001220 , 2106001200 , 2106001197 , 2104001603 , 2201000196 , 2208001930 , 2208001924 , 2208001886 , 2210002945 , 2208001860 , 2111000090 , 2107001825 , 2109002592 , 2107000127 , 2107000115 , 2105002209 , 2205000426 , 2107001697 , 2202001129 , 2105002197 , 2105002192", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.", "Status": "recorded" } } ] } ] }