{ "@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-0092-2025.jsonld", "@type": "schema:Dataset", "name": "VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500", "description": "FDA recall Z-0092-2025 — Maquet Cardiovascular, LLC is recalling VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500 (Devices, Class I). 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. 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Status: Ongoing — the recall is still being carried out.. Initiated 2024-09-20. Affected lots/codes: UDI-DI: VH-3000-W - 00607567700413, VH-3500 - 00607567701250; Lot Numbers: VH-3000-W: 3000365379, 3000382334, 3000392749; VH-3500: 3000333967 3000354228 3000364520 3000376542 3000384902 3000400713 3000339701 3000355224 3000365391 3000376883 3000385174 3000401094 3000340534 3000355369 3000366446 3000377320 3000385849 3000401623 3000341133 3000355798 3000366831 3000377699 3000386206 3000402378 3000341675 3000356048 3000367160 3000378079 3000386871 3000403161 3000342250 3000357837 3000367439 3000378654 3000387986 3000403837 3000342251 3000360574 3000367542 3000379282 3000387987 3000404029 3000343264 3000360576 3000367852 3000379691 3000388401 3000404374 3000343266 3000360775 3000368165 3000380264 3000388676 3000404720 3000344887 3000361036 3000368658 3000380475 3000389329 3000411951 3000345068 3000361423 3000369005 3000380671 3000392530 3000346640 3000361707 3000369122 3000381049 3000392531 3000351187 3000362064 3000369645 3000381287 3000393159 3000351376 3000362258 3000370069 3000381620 3000393427 3000351407 3000362671 3000370290 3000382054 3000393838 3000351619 3000362933 3000372257 3000382868 3000394234 3000351747 3000363162 3000375534 3000383367 3000395128 3000351860 3000363947 3000375776 3000383779 3000398856 3000352770 3000364082 3000376132 3000384088 3000399341 3000354226 3000364309 3000376388 3000384382 3000399911. 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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-0092-2025/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. 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US Nationwide. Brazil, China, and Hong Kong.", "Status": "recorded" } } ] } ] }