{
  "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": "81961",
      "recalling_firm": "Cincinnati Sub-Zero Products LLC, a Gentherm Company",
      "address_1": "12011 Mosteller Rd",
      "address_2": "N/A",
      "postal_code": "45241-1528",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of:  AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI.    The products were distributed to the following foreign countries:  Columbia and Taiwan.",
      "recall_number": "Z-0825-2019",
      "product_description": "Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE    Product Usage:  The HEMOTHERM¿ Model 400CE 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": "396",
      "reason_for_recall": "Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action,  the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.",
      "recall_initiation_date": "20181219",
      "center_classification_date": "20190213",
      "termination_date": "20200424",
      "report_date": "20190220",
      "code_info": "Serial numbers 151-10283CE through 171-10721CE"
    }
  ]
}