{
  "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": "91603",
      "recalling_firm": "Datascope Corp.",
      "address_1": "1300 Macarthur Blvd",
      "address_2": "",
      "postal_code": "07430-2052",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WV;  and OUS (Foreign) countries of: ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELRUS, 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, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO TUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM UZBEKISTAN, VIETNAM, YEMEN AND ZAMBIA.",
      "recall_number": "Z-1148-2023",
      "product_description": "Cardiosave Rescue    Model Nos.  0998-00-0800-75  0998-00-0800-83  0998-00-0800-85",
      "product_quantity": "4793 (US); 4407 (OUS)",
      "reason_for_recall": "An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.",
      "recall_initiation_date": "20230207",
      "center_classification_date": "20230308",
      "report_date": "20230315",
      "code_info": "Model                    UDI  0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449  All serial numbers",
      "more_code_info": ""
    }
  ]
}