{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cincinnati",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80941",
      "recalling_firm": "Cincinnati Sub-Zero Products LLC, a Gentherm Company",
      "address_1": "12011 Mosteller Rd",
      "address_2": "",
      "postal_code": "45241-1528",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution",
      "recall_number": "Z-0063-2019",
      "product_description": "Hemotherm 400CE, Catalog Numbers 86022 & 86023       The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.",
      "product_quantity": "270 units",
      "reason_for_recall": "Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.",
      "recall_initiation_date": "20180904",
      "center_classification_date": "20181003",
      "termination_date": "20190523",
      "report_date": "20181010",
      "code_info": "UDI 10613031860221",
      "more_code_info": ""
    }
  ]
}