{
  "@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-0687-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Brand Name: K-Systems  Product Name: G73 Dry Bath Incubator  Model/Catalog Number: K22065  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: N/A",
  "description": "FDA recall Z-0687-2025 — CooperSurgical, Inc. is recalling Brand Name: K-Systems  Product Name: G73 Dry Bath Incubator  Model/Catalog Number: K22065  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: N/A (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-0687-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: K-Systems  Product Name: G73 Dry Bath Incubator  Model/Catalog Number: K22065  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: N/A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "CooperSurgical, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0687-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0687-2025: CooperSurgical, Inc. is recalling Brand Name: K-Systems  Product Name: G73 Dry Bath Incubator  Model/Catalog Number: K22065  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: N/A",
      "text": "The FDA logged enforcement record Z-0687-2025: CooperSurgical, Inc. is voluntarily recalling Brand Name: K-Systems  Product Name: G73 Dry Bath Incubator  Model/Catalog Number: K22065  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: N/A — 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: K22065; Primary DI Number: 00888937025040; Serial Numbers: 2202KH46, 2202KH47, 2202KH48, 2202KH49, 2202KH50, 2202KH51, 2202KH52, 2202KH53, 2202KH54, 2202KH55, 2208KH01, 2208KH02, 2208KH03, 2208KH04, 2208KH05, 2208KH06, 2208KH07, 2208KH08, 2208KH09, 2208KH10, 2208KH11, 2208KH12, 2208KH13, 2208KH14, 2208KH15, 2208KH16, 2208KH17, 2208KH18, 2208KH19, 2208KH20, 2235KH01, 2235KH02, 2235KH03, 2235KH04, 2235KH05, 2235KH06, 2235KH07, 2235KH08, 2235KH09, 2235KH10, 2235KH11, 2235KH12, 2235KH13, 2235KH14, 2235KH15, 2235KH16, 2235KH17, 2235KH18, 2235KH19, 2235KH20, 2239KH11, 2239KH12, 2239KH13, 2239KH14, 2239KH15, 2239KH16, 2239KH17, 2239KH18, 2239KH19, 2239KH20, 2242KH11, 2242KH12, 2242KH13, 2242KH14, 2242KH15, 2242KH16, 2242KH17, 2242KH18, 2242KH19, 2242KH20, 2242KH21, 2242KH22, 2242KH23, 2242KH24, 2242KH25, 2246KH01, 2246KH02, 2246KH03, 2246KH04, 2246KH05, 2246KH06, 2246KH07, 2246KH08, 2246KH09, 2246KH10, 2246KH11, 2246KH12, 2246KH13, 2246KH14, 2246KH15, 2246KH16, 2246KH17, 2246KH18, 2246KH19, 2246KH20, 2246KH21, 2246KH22, 2246KH23, 2246KH24, 2246KH25, 2246KH26, 2246KH27, 2246KH28, 2246KH29, 2246KH30, 2246KH31, 2246KH32, 2246KH33, 2246KH34, 2246KH35, 2246KH36, 2246KH37, 2246KH38, 2246KH39, 2246KH40, 2246KH41, 2246KH42, 2246KH43, 2246KH44, 2246KH45, 2246KH46, 2246KH47, 2246KH48, 2246KH49, 2246KH50, 2246KH51, 2246KH52, 2246KH53, 2246KH54, 2246KH55, 2303KH01, 2303KH02, 2303KH03, 2303KH04, 2303KH05, 2303KH06, 2303KH07, 2303KH08, 2303KH09, 2303KH10, 2303KH11, 2303KH12, 2303KH13, 2303KH14, 2303KH15, 2303KH16, 2303KH17, 2303KH18, 2303KH19, 2303KH20, 2303KH21, 2303KH22, 2303KH23, 2303KH24, 2303KH25, 2303KH26, 2303KH27, 2303KH28, 2303KH29, 2303KH30, 2303KH31, 2303KH32, 2303KH33, 2303KH34, 2303KH35, 2303KH36, 2303KH37, 2303KH38, 2303KH39, 2303KH40, 2311KH01, 2311KH02, 2311KH03, 2311KH04, 2311KH05, 2311KH06, 2311KH07, 2311KH08, 2311KH09, 2311KH10, 2311KH11, 2311KH12, 2311KH13, 2311KH14, 2311KH15, 2313KH11, 2313KH12, 2313KH13, 2313KH14, 2313KH15, 2313KH16, 2313KH17, 2313KH18, 2313KH19, 2313KH20, 2313KH21, 2313KH22, 2313KH23, 2313KH24, 2313KH25, 2316KH01, 2316KH02, 2316KH03, 2316KH04, 2316KH05, 2316KH06, 2316KH07, 2316KH08, 2316KH09, 2316KH10, 2316KH11, 2316KH12, 2316KH13, 2316KH14, 2316KH15, 2322KH11, 2322KH12, 2322KH13, 2322KH14, 2322KH15, 2322KH16, 2322KH17, 2322KH18, 2322KH19, 2322KH20, 2322KH21, 2322KH22, 2322KH23, 2322KH24, 2322KH25, 2326KH01, 2326KH02, 2326KH03, 2326KH04, 2326KH05, 2326KH06, 2326KH07, 2326KH08, 2326KH09, 2326KH10, 2326KH11, 2326KH12, 2326KH13, 2326KH14, 2326KH15, 2326KH16, 2326KH17, 2326KH18, 2326KH19, 2326KH20, 2327KH30, 2327KH31, 2327KH32, 2327KH33, 2327KH34, 2327KH35, 2327KH36, 2327KH37, 2327KH38, 2327KH39, 2327KH40, 2327KH41, 2327KH42, 2327KH43, 2327KH44, 2332KH11, 2332KH12, 2332KH13, 2332KH14, 2332KH15, 2332KH16, 2332KH17, 2332KH18, 2332KH19, 2332KH20.. 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-0687-2025&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-0687-2025&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-0687-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0687-2025 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-0687-2025&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-0687-2025&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-0687-2025/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-0687-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0687-2025",
            "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: K22065; Primary DI Number: 00888937025040; Serial Numbers: 2202KH46, 2202KH47, 2202KH48, 2202KH49, 2202KH50, 2202KH51, 2202KH52, 2202KH53, 2202KH54, 2202KH55, 2208KH01, 2208KH02, 2208KH03, 2208KH04, 2208KH05, 2208KH06, 2208KH07, 2208KH08, 2208KH09, 2208KH10, 2208KH11, 2208KH12, 2208KH13, 2208KH14, 2208KH15, 2208KH16, 2208KH17, 2208KH18, 2208KH19, 2208KH20, 2235KH01, 2235KH02, 2235KH03, 2235KH04, 2235KH05, 2235KH06, 2235KH07, 2235KH08, 2235KH09, 2235KH10, 2235KH11, 2235KH12, 2235KH13, 2235KH14, 2235KH15, 2235KH16, 2235KH17, 2235KH18, 2235KH19, 2235KH20, 2239KH11, 2239KH12, 2239KH13, 2239KH14, 2239KH15, 2239KH16, 2239KH17, 2239KH18, 2239KH19, 2239KH20, 2242KH11, 2242KH12, 2242KH13, 2242KH14, 2242KH15, 2242KH16, 2242KH17, 2242KH18, 2242KH19, 2242KH20, 2242KH21, 2242KH22, 2242KH23, 2242KH24, 2242KH25, 2246KH01, 2246KH02, 2246KH03, 2246KH04, 2246KH05, 2246KH06, 2246KH07, 2246KH08, 2246KH09, 2246KH10, 2246KH11, 2246KH12, 2246KH13, 2246KH14, 2246KH15, 2246KH16, 2246KH17, 2246KH18, 2246KH19, 2246KH20, 2246KH21, 2246KH22, 2246KH23, 2246KH24, 2246KH25, 2246KH26, 2246KH27, 2246KH28, 2246KH29, 2246KH30, 2246KH31, 2246KH32, 2246KH33, 2246KH34, 2246KH35, 2246KH36, 2246KH37, 2246KH38, 2246KH39, 2246KH40, 2246KH41, 2246KH42, 2246KH43, 2246KH44, 2246KH45, 2246KH46, 2246KH47, 2246KH48, 2246KH49, 2246KH50, 2246KH51, 2246KH52, 2246KH53, 2246KH54, 2246KH55, 2303KH01, 2303KH02, 2303KH03, 2303KH04, 2303KH05, 2303KH06, 2303KH07, 2303KH08, 2303KH09, 2303KH10, 2303KH11, 2303KH12, 2303KH13, 2303KH14, 2303KH15, 2303KH16, 2303KH17, 2303KH18, 2303KH19, 2303KH20, 2303KH21, 2303KH22, 2303KH23, 2303KH24, 2303KH25, 2303KH26, 2303KH27, 2303KH28, 2303KH29, 2303KH30, 2303KH31, 2303KH32, 2303KH33, 2303KH34, 2303KH35, 2303KH36, 2303KH37, 2303KH38, 2303KH39, 2303KH40, 2311KH01, 2311KH02, 2311KH03, 2311KH04, 2311KH05, 2311KH06, 2311KH07, 2311KH08, 2311KH09, 2311KH10, 2311KH11, 2311KH12, 2311KH13, 2311KH14, 2311KH15, 2313KH11, 2313KH12, 2313KH13, 2313KH14, 2313KH15, 2313KH16, 2313KH17, 2313KH18, 2313KH19, 2313KH20, 2313KH21, 2313KH22, 2313KH23, 2313KH24, 2313KH25, 2316KH01, 2316KH02, 2316KH03, 2316KH04, 2316KH05, 2316KH06, 2316KH07, 2316KH08, 2316KH09, 2316KH10, 2316KH11, 2316KH12, 2316KH13, 2316KH14, 2316KH15, 2322KH11, 2322KH12, 2322KH13, 2322KH14, 2322KH15, 2322KH16, 2322KH17, 2322KH18, 2322KH19, 2322KH20, 2322KH21, 2322KH22, 2322KH23, 2322KH24, 2322KH25, 2326KH01, 2326KH02, 2326KH03, 2326KH04, 2326KH05, 2326KH06, 2326KH07, 2326KH08, 2326KH09, 2326KH10, 2326KH11, 2326KH12, 2326KH13, 2326KH14, 2326KH15, 2326KH16, 2326KH17, 2326KH18, 2326KH19, 2326KH20, 2327KH30, 2327KH31, 2327KH32, 2327KH33, 2327KH34, 2327KH35, 2327KH36, 2327KH37, 2327KH38, 2327KH39, 2327KH40, 2327KH41, 2327KH42, 2327KH43, 2327KH44, 2332KH11, 2332KH12, 2332KH13, 2332KH14, 2332KH15, 2332KH16, 2332KH17, 2332KH18, 2332KH19, 2332KH20.",
            "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"
          }
        }
      ]
    }
  ]
}