{
  "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": "90684",
      "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": "Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.",
      "recall_number": "Z-1686-2022",
      "product_description": "Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter",
      "product_quantity": "10,427 units",
      "reason_for_recall": "Certain lots containing undersized dilator.",
      "recall_initiation_date": "20220805",
      "center_classification_date": "20220908",
      "report_date": "20220914",
      "code_info": "Code information reads \"UDI-DI, Lot No., Finished Goods Part No.\": 10607567108605, 3000168086, 0684-00-0576-01; 10607567108605, 3000217952, 0684-00-0576-01; 10607567109633, 3000166607, 0684-00-0576-01U; 10607567109633, 3000169722, 0684-00-0576-01U; 10607567109633, 3000172352, 0684-00-0576-01U; 10607567109633, 3000172353, 0684-00-0576-01U; 10607567109633, 3000176574, 0684-00-0576-01U; 10607567109633, 3000176633, 0684-00-0576-01U; 10607567109633, 3000185680, 0684-00-0576-01U; 10607567109633, 3000196023, 0684-00-0576-01U; 10607567109633, 3000199196, 0684-00-0576-01U; 10607567109633, 3000199197, 0684-00-0576-01U; 10607567109633, 3000199198, 0684-00-0576-01U; 10607567109633, 3000200147, 0684-00-0576-01U; 10607567109633, 3000213850, 0684-00-0576-01U"
    }
  ]
}