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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0689-2025.jsonld",
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  "name": "Brand Name: K-Systems  Product Name: T47 Warming Plate  Model/Catalog Number: K23054  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-0689-2025 — CooperSurgical, Inc. is recalling Brand Name: K-Systems  Product Name: T47 Warming Plate  Model/Catalog Number: K23054  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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0689-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: K-Systems  Product Name: T47 Warming Plate  Model/Catalog Number: K23054  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."
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  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0689-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0689-2025: CooperSurgical, Inc. is recalling Brand Name: K-Systems  Product Name: T47 Warming Plate  Model/Catalog Number: K23054  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-0689-2025: CooperSurgical, Inc. is voluntarily recalling Brand Name: K-Systems  Product Name: T47 Warming Plate  Model/Catalog Number: K23054  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: K23054; Primary DI Number: 00888937025071; Serial Numbers: 2218KH46 , 2218KH47 , 2218KH48 , 2218KH49 , 2218KH50 , 2218KH51 , 2218KH52 , 2218KH53 , 2218KH54 , 2218KH55 , 2218KH56 , 2218KH57 , 2218KH58 , 2218KH59 , 2218KH60 , 2233KH11 , 2233KH12 , 2233KH13 , 2233KH14 , 2233KH15 , 2233KH16 , 2233KH17 , 2233KH18 , 2233KH19 , 2233KH20 , 2235KH31 , 2235KH32 , 2235KH33 , 2235KH34 , 2235KH35 , 2235KH36 , 2235KH37 , 2235KH38 , 2235KH39 , 2235KH40 , 2237KH11 , 2237KH12 , 2237KH13 , 2237KH14 , 2237KH15 , 2237KH16 , 2237KH17 , 2237KH18 , 2237KH19 , 2237KH20 , 2242KH01 , 2242KH02 , 2242KH03 , 2242KH04 , 2242KH05 , 2242KH06 , 2242KH07 , 2242KH08 , 2242KH09 , 2242KH10 , 2250KH01 , 2250KH02 , 2250KH03 , 2250KH04 , 2250KH05 , 2250KH06 , 2250KH07 , 2250KH08 , 2250KH09 , 2250KH10 , 2309KH41 , 2309KH42 , 2309KH43 , 2309KH44 , 2309KH45 , 2309KH46 , 2309KH47 , 2309KH48 , 2309KH49 , 2309KH50 , 2320KH01 , 2320KH02 , 2320KH03 , 2320KH04 , 2320KH05 , 2320KH06 , 2320KH07 , 2320KH08 , 2320KH09 , 2320KH10 , 2322KH01 , 2322KH02 , 2322KH03 , 2322KH04 , 2322KH05 , 2322KH06 , 2322KH07 , 2322KH08 , 2322KH09 , 2322KH10 , 2337KH01, 2337KH02, 2337KH03, 2337KH04, 2337KH05, 2337KH06, 2337KH07, 2337KH08, 2337KH09, 2337KH10,. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "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-0689-2025&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-0689-2025&lang=eng"
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      "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-0689-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0689-2025 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,
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        "adjudged": true,
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-0689-2025&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-0689-2025/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
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      "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."
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      "name": "FDA recall details — Z-0689-2025",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-0689-2025",
            "Status": "recorded"
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          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        {
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "CooperSurgical, Inc.",
            "Status": "recorded"
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          "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"
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        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-11-15",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Version or Model: K23054; Primary DI Number: 00888937025071; Serial Numbers: 2218KH46 , 2218KH47 , 2218KH48 , 2218KH49 , 2218KH50 , 2218KH51 , 2218KH52 , 2218KH53 , 2218KH54 , 2218KH55 , 2218KH56 , 2218KH57 , 2218KH58 , 2218KH59 , 2218KH60 , 2233KH11 , 2233KH12 , 2233KH13 , 2233KH14 , 2233KH15 , 2233KH16 , 2233KH17 , 2233KH18 , 2233KH19 , 2233KH20 , 2235KH31 , 2235KH32 , 2235KH33 , 2235KH34 , 2235KH35 , 2235KH36 , 2235KH37 , 2235KH38 , 2235KH39 , 2235KH40 , 2237KH11 , 2237KH12 , 2237KH13 , 2237KH14 , 2237KH15 , 2237KH16 , 2237KH17 , 2237KH18 , 2237KH19 , 2237KH20 , 2242KH01 , 2242KH02 , 2242KH03 , 2242KH04 , 2242KH05 , 2242KH06 , 2242KH07 , 2242KH08 , 2242KH09 , 2242KH10 , 2250KH01 , 2250KH02 , 2250KH03 , 2250KH04 , 2250KH05 , 2250KH06 , 2250KH07 , 2250KH08 , 2250KH09 , 2250KH10 , 2309KH41 , 2309KH42 , 2309KH43 , 2309KH44 , 2309KH45 , 2309KH46 , 2309KH47 , 2309KH48 , 2309KH49 , 2309KH50 , 2320KH01 , 2320KH02 , 2320KH03 , 2320KH04 , 2320KH05 , 2320KH06 , 2320KH07 , 2320KH08 , 2320KH09 , 2320KH10 , 2322KH01 , 2322KH02 , 2322KH03 , 2322KH04 , 2322KH05 , 2322KH06 , 2322KH07 , 2322KH08 , 2322KH09 , 2322KH10 , 2337KH01, 2337KH02, 2337KH03, 2337KH04, 2337KH05, 2337KH06, 2337KH07, 2337KH08, 2337KH09, 2337KH10,",
            "Status": "recorded"
          }
        },
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          "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"
          }
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      ]
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}