{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Ann Arbor",
      "address_1": "6200 Jackson Road",
      "reason_for_recall": "Internal testing found certain Sarns\" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.",
      "address_2": "",
      "product_quantity": "7 units",
      "code_info": "Catalog Number 4416 and Serial Numbers: 4656, 4657, 4658,4659, 4661, 4662, and 4663.",
      "center_classification_date": "20130621",
      "distribution_pattern": "Worldwide Distribution including the countries of UAE (United Arab Emirates)  HONG KONG and THAILAND.  Not distributed in USA",
      "state": "MI",
      "product_description": "Sarns \" TCM II Temperature Control Module    The Sarns\" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature",
      "report_date": "20130703",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "recall_number": "Z-1569-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "64530",
      "termination_date": "20130917",
      "more_code_info": "",
      "recall_initiation_date": "20130530",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}