{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Ann Arbor",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70492",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Rd",
      "address_2": "",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US (nationwide) including the states of AR, CA, CO, CT, FL, IA, IL, KS, KY, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA, and WI and the country of  Japan.",
      "recall_number": "Z-1116-2015",
      "product_description": "Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.",
      "product_quantity": "103 units",
      "reason_for_recall": "Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion).  Mixing valves need to be replaced at regular intervals.",
      "recall_initiation_date": "20150206",
      "center_classification_date": "20150213",
      "termination_date": "20161017",
      "report_date": "20150225",
      "code_info": "HX2 Temperature Management System, 120V   Catalog # 809810   serial numbers: 00016, 0001 \u0013 1116    HX2 Temperature Management System, 100V  Catalog # 812231   serial numbers: 0001, 1002, PT0003, PT0004     HX2 Temperature Management System, 240V  Catalog # 812240    serial numbers: 0001, 0002    HX2 Temperature Management System, Trial Kit  Catalog # 809810TK     serial numbers: 1001 \u0013 1042",
      "more_code_info": ""
    }
  ]
}