{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Trumbull",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95741",
      "recalling_firm": "CooperSurgical, Inc.",
      "address_1": "95 Corporate Dr",
      "address_2": "",
      "postal_code": "06611-1350",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "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",
      "recall_number": "Z-0688-2025",
      "product_description": "Brand Name: K-Systems  Product Name: G85 Mini Incubator  Model/Catalog Number: K22074  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",
      "product_quantity": "37 units",
      "reason_for_recall": "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.",
      "recall_initiation_date": "20241115",
      "center_classification_date": "20241218",
      "report_date": "20241225",
      "code_info": "Version or Model: K22074; Primary DI Number: 00888937025057; Serial Numbers: 2244KH01 , 2244KH02 , 2244KH03 , 2244KH04 , 2244KH05 , 2244KH06 , 2244KH07 , 2244KH08 , 2244KH09 , 2244KH10 , 2313KH01 , 2313KH02 , 2313KH03 , 2313KH04 , 2313KH05 , 2313KH06 , 2313KH07 , 2313KH08 , 2313KH09 , 2313KH10 , 2320KH21 , 2320KH22 , 2320KH23 , 2320KH24 , 2320KH25 , 2320KH26 , 2320KH27 , 2320KH28 , 2320KH29 , 2320KH30 , 2321KH16 , 2321KH17 , 2321KH18 , 2321KH19 , 2321KH20,",
      "more_code_info": ""
    }
  ]
}