{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Fairfield",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85823",
      "recalling_firm": "Datascope Corporation",
      "address_1": "15 Law Dr",
      "address_2": "N/A",
      "postal_code": "07004-3206",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.",
      "recall_number": "Z-2838-2020",
      "product_description": "Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit   P/N: 0684-00-0478-01, 0684-00-0478-01C,  0684-00-0478-01U  0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For  Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.",
      "product_quantity": "1746 kits WW",
      "reason_for_recall": "Potential Endotoxin Contamination",
      "recall_initiation_date": "20200727",
      "center_classification_date": "20200821",
      "report_date": "20200902",
      "code_info": "Kit Lot Number:   3000049797  3000053552  3000056193  3000056201  3000057749  3000066195  3000067965  3000069878  3000071222  3000072585  3000074287  3000078937  3000079446  3000080540  3000084470  3000090372  3000092553  3000095910  3000099930  3000103632  3000112148  3000053297  3000057125  3000072586  3000049798  3000053553  3000057748  3000061193  3000066264  3000069270  3000071221  3000072584  3000074288  3000077341  3000077814  3000083060  3000084471  3000087477  3000087478  3000088619  3000090373  3000092552  3000095911  3000099932  3000103631  3000053554  3000056540  3000061194  3000068728  3000092554  3000095912  3000099933  3000102246  3000049800  3000074289  3000092555  3000099931"
    }
  ]
}