{
  "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": "Blue Ash",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88187",
      "recalling_firm": "Gentherm Medical, LLC",
      "address_1": "12011 Mosteller Rd Fl 3",
      "address_2": "N/A",
      "postal_code": "45241-1528",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.  US nationwide, including Puerto Rico;  Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan, Philippines, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turkey, UAE",
      "recall_number": "Z-2092-2021",
      "product_description": "Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022.  Used to cool or warm blood during cardiopulmonary bypass procedures",
      "product_quantity": "1448 devices (1010 US; 438 OUS)",
      "reason_for_recall": "There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.",
      "recall_initiation_date": "20210617",
      "center_classification_date": "20210719",
      "termination_date": "20230301",
      "report_date": "20210728",
      "code_info": "All units in service life  Serial Numbers:  092-10011CE tot 212-11499CE",
      "more_code_info": ""
    }
  ]
}