{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92335",
      "recalling_firm": "Datascope Corp.",
      "address_1": "1300 Macarthur Blvd",
      "address_2": "N/A",
      "postal_code": "07430-2052",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution- US (Nationwide) and OUS (foreign) countries of: ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, AZERBAIJAN , BAHRAIN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, C¿te d'Ivoire, CROATIA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GHANA, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOSOVO, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM, YEMEN, ZAMBIA",
      "recall_number": "Z-2151-2023",
      "product_description": "Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers   0998-00-0800-31  0998-00-0800-32  0998-00-0800-33  0998-00-0800-34  0998-00-0800-35  0998-00-0800-45  0998-00-0800-52  0998-00-0800-53  0998-00-0800-55  0998-00-0800-65    0998-UC-0800-31*  0998-UC-0800-33*  0998-UC-0800-52*  0998-UC-0800-53*  0998-00-0800-55*    *Not US distribution",
      "product_quantity": "9174 (4586 US; 4588 OUS) in total",
      "reason_for_recall": "An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the  Power Management Board and/or Solenoid Board.  This issue may lead to an unexpected interruption of therapy.",
      "recall_initiation_date": "20230605",
      "center_classification_date": "20230720",
      "report_date": "20230726",
      "code_info": "All Unit Serial Numbers  Model                    UDI 0998-00-0800-31 10607567109053 0998-00-0800-32 10607567111117 0998-00-0800-33 10607567109008 0998-00-0800-34 10607567111940 0998-00-0800-35 10607567109107 0998-00-0800-45 10607567108421 0998-00-0800-52 10607567108438 0998-00-0800-53 10607567108391 0998-00-0800-55 10607567108414 0998-00-0800-65 10607567113432",
      "more_code_info": ""
    }
  ]
}