{ "@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-0690-2025.jsonld", "@type": "schema:Dataset", "name": "Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No", "description": "FDA recall Z-0690-2025 — CooperSurgical, Inc. is recalling Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No (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-0690-2025&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No", "manufacturer": { "@type": "schema:Organization", "name": "CooperSurgical, Inc." } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0690-2025/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-0690-2025: CooperSurgical, Inc. is recalling Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No", "text": "The FDA logged enforcement record Z-0690-2025: CooperSurgical, Inc. is voluntarily recalling Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No — reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-15. Affected lots/codes: Version or Model: K23055; Primary DI Number: 00888937025064; Serial Numbers: 2223KH01 , 2223KH02 , 2223KH03 , 2223KH04 , 2223KH05 , 2223KH06 , 2223KH07 , 2223KH08 , 2223KH09 , 2223KH10 , 2235KH21 , 2235KH22 , 2235KH23 , 2235KH24 , 2235KH25 , 2235KH26 , 2235KH27 , 2235KH28 , 2235KH29 , 2235KH30 , 2237KH01 , 2237KH02 , 2237KH03 , 2237KH04 , 2237KH05 , 2237KH06 , 2237KH07 , 2237KH08 , 2237KH09 , 2237KH10 , 2250KH11 , 2250KH12 , 2250KH13 , 2250KH14 , 2250KH15 , 2250KH16 , 2250KH17 , 2250KH18 , 2250KH19 , 2250KH20 , 2303KH41 , 2303KH42 , 2303KH43 , 2303KH44 , 2303KH45 , 2303KH46 , 2303KH47 , 2303KH48 , 2303KH49 , 2303KH50 , 2309KH31 , 2309KH32 , 2309KH33 , 2309KH34 , 2309KH35 , 2309KH36 , 2309KH37 , 2309KH38 , 2309KH39 , 2309KH40 , 2311KH16 , 2311KH17 , 2311KH18 , 2311KH19 , 2311KH20 , 2311KH21 , 2311KH22 , 2311KH23 , 2311KH24 , 2311KH25 , 2320KH41 , 2320KH42 , 2320KH43 , 2320KH44 , 2320KH45 , 2320KH46 , 2320KH47 , 2320KH48 , 2320KH49 , 2320KH50 , 2324KH33 , 2324KH34 , 2324KH35 , 2324KH36 , 2324KH37 , 2324KH38 , 2324KH39 , 2324KH40 , 2324KH41 , 2324KH42 , 2327KH20 , 2327KH21 , 2327KH22 , 2327KH23 , 2327KH24 , 2327KH25 , 2327KH26 , 2327KH27 , 2327KH28 , 2327KH29 , 2333KH01, 2333KH02, 2333KH03, 2333KH04, 2333KH05, 2333KH06, 2333KH07, 2333KH08, 2333KH09, 2333KH10, 2333KH21, 2333KH22, 2333KH23, 2333KH24, 2333KH25, 2333KH26, 2333KH27, 2333KH28, 2333KH29, 2333KH30, 2333KH31, 2333KH32, 2333KH33, 2333KH34, 2333KH35, 2335KH51, 2335KH52, 2335KH53, 2335KH54, 2335KH55, 2335KH56, 2335KH57, 2335KH58, 2335KH59, 2335KH60, 2335KH61, 2335KH62, 2335KH63, 2335KH64, 2335KH65, 2335KH66, 2335KH67, 2335KH68, 2335KH69, 2335KH70, 2335KH71, 2335KH72, 2335KH73, 2335KH74, 2335KH75, 2335KH76, 2335KH77, 2335KH78, 2335KH79, 2335KH80, 2335KH81, 2335KH82, 2335KH83, 2335KH84, 2335KH85, 2335KH86, 2335KH87, 2335KH88, 2335KH89, 2335KH90, 2345KH11, 2345KH12, 2345KH13, 2345KH14, 2345KH15, 2345KH16, 2345KH17, 2345KH18, 2345KH19, 2345KH20, 2345KH21, 2345KH22, 2345KH23, 2345KH24, 2345KH25,. 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-0690-2025&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-0690-2025&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-0690-2025/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-0690-2025 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-0690-2025&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-0690-2025&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-0690-2025/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-0690-2025", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-0690-2025", "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": "CooperSurgical, Inc.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2024-11-15", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "Version or Model: K23055; Primary DI Number: 00888937025064; Serial Numbers: 2223KH01 , 2223KH02 , 2223KH03 , 2223KH04 , 2223KH05 , 2223KH06 , 2223KH07 , 2223KH08 , 2223KH09 , 2223KH10 , 2235KH21 , 2235KH22 , 2235KH23 , 2235KH24 , 2235KH25 , 2235KH26 , 2235KH27 , 2235KH28 , 2235KH29 , 2235KH30 , 2237KH01 , 2237KH02 , 2237KH03 , 2237KH04 , 2237KH05 , 2237KH06 , 2237KH07 , 2237KH08 , 2237KH09 , 2237KH10 , 2250KH11 , 2250KH12 , 2250KH13 , 2250KH14 , 2250KH15 , 2250KH16 , 2250KH17 , 2250KH18 , 2250KH19 , 2250KH20 , 2303KH41 , 2303KH42 , 2303KH43 , 2303KH44 , 2303KH45 , 2303KH46 , 2303KH47 , 2303KH48 , 2303KH49 , 2303KH50 , 2309KH31 , 2309KH32 , 2309KH33 , 2309KH34 , 2309KH35 , 2309KH36 , 2309KH37 , 2309KH38 , 2309KH39 , 2309KH40 , 2311KH16 , 2311KH17 , 2311KH18 , 2311KH19 , 2311KH20 , 2311KH21 , 2311KH22 , 2311KH23 , 2311KH24 , 2311KH25 , 2320KH41 , 2320KH42 , 2320KH43 , 2320KH44 , 2320KH45 , 2320KH46 , 2320KH47 , 2320KH48 , 2320KH49 , 2320KH50 , 2324KH33 , 2324KH34 , 2324KH35 , 2324KH36 , 2324KH37 , 2324KH38 , 2324KH39 , 2324KH40 , 2324KH41 , 2324KH42 , 2327KH20 , 2327KH21 , 2327KH22 , 2327KH23 , 2327KH24 , 2327KH25 , 2327KH26 , 2327KH27 , 2327KH28 , 2327KH29 , 2333KH01, 2333KH02, 2333KH03, 2333KH04, 2333KH05, 2333KH06, 2333KH07, 2333KH08, 2333KH09, 2333KH10, 2333KH21, 2333KH22, 2333KH23, 2333KH24, 2333KH25, 2333KH26, 2333KH27, 2333KH28, 2333KH29, 2333KH30, 2333KH31, 2333KH32, 2333KH33, 2333KH34, 2333KH35, 2335KH51, 2335KH52, 2335KH53, 2335KH54, 2335KH55, 2335KH56, 2335KH57, 2335KH58, 2335KH59, 2335KH60, 2335KH61, 2335KH62, 2335KH63, 2335KH64, 2335KH65, 2335KH66, 2335KH67, 2335KH68, 2335KH69, 2335KH70, 2335KH71, 2335KH72, 2335KH73, 2335KH74, 2335KH75, 2335KH76, 2335KH77, 2335KH78, 2335KH79, 2335KH80, 2335KH81, 2335KH82, 2335KH83, 2335KH84, 2335KH85, 2335KH86, 2335KH87, 2335KH88, 2335KH89, 2335KH90, 2345KH11, 2345KH12, 2345KH13, 2345KH14, 2345KH15, 2345KH16, 2345KH17, 2345KH18, 2345KH19, 2345KH20, 2345KH21, 2345KH22, 2345KH23, 2345KH24, 2345KH25,", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "States: NC, NJ, TX, VA, IL, NY, CA, PA Please note: The countries below, excluding Iraq, all consider these devices to be \"lab equipment\", not medical devices and are not subject to classification or recall guidelines. Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZA", "Status": "recorded" } } ] } ] }