{
  "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": "2026-10-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "164360",
      "product_res_number": "Z-1901-2018",
      "event_date_initiated": "2018-04-20",
      "event_date_posted": "2018-05-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2025-02-05",
      "res_event_number": "80072",
      "product_code": "DWC",
      "k_numbers": [
        "K052601"
      ],
      "product_description": "Sorin Stockert Heater-Cooler System 3T, \n\na) Item #: 16-02-81, 240 v/60 Hz;\n\nb) Item #: 16-02-82, 208 v/60 Hz;\n\nc) Item #: 16-02-85, 120 v/60 Hz",
      "code_info": "Serial #: a) 16S10743 - 6S11708  b) 16S10772 - 16S16840  C) 16S10958 - 16S16847",
      "firm_fei_number": "1718850",
      "recalling_firm": "LivaNova USA",
      "address_1": "14401 W 65th Way",
      "city": "Arvada",
      "state": "CO",
      "postal_code": "80004-3503",
      "additional_info_contact": "Joan Ceasar\n281-228-7260",
      "reason_for_recall": "Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm.",
      "root_cause_description": "Device Design",
      "action": "On 04/20/2018, a Medical Device Correction notice was sent to customers informing them to return devices less than ten years old. Returned devices will receive a deep cleaning service, which will reduce microbial contamination to HPC < 100 CFU/ml of water and NTM < 1 CFU/100ml.",
      "product_quantity": "2408",
      "distribution_pattern": "MN, TX, WA, OR, IL, OH, SC, AK, PA, CA, WI, GA, NJ, FL, AZ, KY, MS, MO, LA, AR, MA, MI, MT, CO, TN, NE, NC, VA, NV, HI, PR, WY, AL, OK, IN, CT, ME, IA, SC, KS, NM, SD, DC, MD, ND,",
      "openfda": {
        "k_number": [
          "K140012",
          "K102147",
          "K810647",
          "K014016",
          "K873813",
          "K130300",
          "K220635",
          "K896975",
          "K191402",
          "K896972",
          "K896973",
          "K831677",
          "K001520",
          "K873699",
          "K896974",
          "K896393",
          "K841402",
          "K874927",
          "K031544",
          "K052601",
          "K883603",
          "K122813",
          "K212657",
          "K945720",
          "K896971",
          "K822874",
          "K893940",
          "K071521",
          "K003145",
          "K873924"
        ],
        "registration_number": [
          "9611109",
          "1649914",
          "1928237",
          "1828100",
          "3007899424",
          "1723241",
          "3001588119",
          "1516825",
          "1720929",
          "3006073153"
        ],
        "fei_number": [
          "3001665800",
          "3002808267",
          "1928237",
          "1828100",
          "1000517719",
          "3007899424",
          "3001588119",
          "1516825",
          "1720929",
          "3006073153"
        ],
        "device_name": "Controller, Temperature, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4250",
        "device_class": "2"
      }
    }
  ]
}