{
  "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,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92214",
      "recalling_firm": "Datascope Corp.",
      "address_1": "1300 Macarthur Blvd",
      "address_2": "N/A",
      "postal_code": "07430-2052",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "International distribution in the country of Germany.",
      "recall_number": "Z-1907-2023",
      "product_description": "Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX",
      "product_quantity": "4 units",
      "reason_for_recall": "The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.",
      "recall_initiation_date": "20230504",
      "center_classification_date": "20230614",
      "report_date": "20230621",
      "code_info": "UDI-DI: 10607567108414; Serial Numbers: CB286971I8 CB283804G8 CB283867G8 CB283522G8"
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}