{
  "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-2831-2020",
      "product_description": "Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB,   P/N:  0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For  Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.",
      "product_quantity": "1275 kits WW",
      "reason_for_recall": "Potential Endotoxin Contamination",
      "recall_initiation_date": "20200727",
      "center_classification_date": "20200821",
      "report_date": "20200902",
      "code_info": "Kit Lot Number:   3000047044  3000049910  3000055308  3000059274  3000064252  3000067462  3000071220  3000077343  3000084725  3000086853  3000087475  3000087971  3000096716  3000097647  3000100873  3000102114  3000109816  3000047042  3000047931  3000049913  3000055307  3000056433  3000059275  3000060230  3000062405  3000064251  3000067461  3000067855  3000071981  3000071219  3000071982  3000077342  3000080542  3000081080  3000084724  3000086852  3000087972  3000096715  3000090374  3000092556  3000097646  3000102113  3000106149  3000112151  3000114260  3000047043  3000049911  3000064746  3000067463  3000084473  3000097648  3000112153  3000047041  3000047932  3000049912  3000067856  3000071983  3000087476  3000096793  3000097649  3000112152"
    }
  ]
}