{
  "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": "Arvada",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85098",
      "recalling_firm": "LivaNova USA Inc.",
      "address_1": "14401 W 65th Way",
      "address_2": "",
      "postal_code": "80004-3503",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide distribution including Puerto Rico.    This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected.    O.U.S. - none",
      "recall_number": "Z-1498-2020",
      "product_description": "LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.",
      "product_quantity": "Total Worldwide=9309 systems (2713 system in U.S.)",
      "reason_for_recall": "The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.",
      "recall_initiation_date": "20200224",
      "center_classification_date": "20200313",
      "termination_date": "20220804",
      "report_date": "20200325",
      "code_info": "Device Listing: E572259    Product Code  Product Description          Affected Serial Number range  16-02-80          Heater-Cooler 3T, 230V   16S10027   16S16874  16-02-81          Heater-Cooler 3T, 240V   16S10743   16S11708  16-02-82          Heater-Cooler 3T, 208V   16S10772   16S16840  16-02-83          Heater-Cooler 3T, 127V   16S11455   16S16509  16-02-85          Heater-Cooler 3T, 120V   16S10958   16S16847  16-02-95          Heater-Cooler 3T, 200V   16S12004   16S16818",
      "more_code_info": ""
    }
  ]
}