{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Ann Arbor",
      "address_1": "6200 Jackson Road",
      "reason_for_recall": "Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst",
      "address_2": "",
      "product_quantity": "484 units",
      "code_info": "Catalog Number 164300 and serial number 1006-5462",
      "center_classification_date": "20120719",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of  ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, GERMANY, Guatemala, HOLLAND, Honduras, Hong Kong, India, INDIA, Indonesia, Israel, ITALY, Jordan, KOREA, Kuwait, Lebanon, LEICESTERSHIRE, Malaysia, Mexico, NETHERLANDS, New Zealand, Nicaragua, NORWAY, Pakistan, Panama, PERU, Philippines, Russia, Saudi Arabia, SINGAPORE , SOUTH AFRICA, South Korea, SPAIN, Sri Lanka, SWEDEN, SWITZERLAND, Taiwan, THAILAND, Turkey, UNITED ARAB EMIRATES (UAE), Uruguay, Venezuela, Vietnam, WEST GERMANY and Yemen.",
      "state": "MI",
      "product_description": "Sarns Modular Perfusion System 9000, 115V with color screen.    The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.",
      "report_date": "20120725",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "recall_number": "Z-2050-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "61479",
      "termination_date": "20130412",
      "more_code_info": "",
      "recall_initiation_date": "20120618",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}