{
  "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-2844-2020",
      "product_description": "Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For  Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.",
      "product_quantity": "11555 Kits",
      "reason_for_recall": "Potential Endotoxin Contamination",
      "recall_initiation_date": "20200727",
      "center_classification_date": "20200821",
      "report_date": "20200902",
      "code_info": "Kit Lot Number:   3000045568  3000047929  3000047928  3000047930  3000053321  3000060109  3000060110  3000067699  3000062192  3000067700  3000067701  3000069728  3000069729  3000069730  3000071288  3000073187  3000076242  3000077669  3000079105  3000079318  3000080309  3000080876  3000084268  3000084967  3000084960  3000084961  3000086800  3000088372  3000090597  3000090598  3000092668  3000092666  3000092667  3000092669  3000096268  3000095468  3000096267  3000096269  3000096270  3000096271  3000096587  3000098175  3000098747  3000098748  3000102410  3000102411  3000103470  3000104519  3000106011  3000107760  3000110622  3000110623  3000112744  3000113154"
    }
  ]
}