{
  "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": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87993",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "1 Edwards Way",
      "address_2": "N/A",
      "postal_code": "92614-5688",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: AZ  CA  CO  CT  DC  DE  FL  GA  ID  IL  IN  KY  LA  MA  MD  ME  MI  MN  MO  MS  MT  NC  ND  NE  NJ  PR  SD  TX  UT  VA  WA  WI  WV    OUS: Canada, United Kingdom, Italy",
      "recall_number": "Z-1962-2021",
      "product_description": "Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520",
      "product_quantity": "2,000 units",
      "reason_for_recall": "There is a potential that the pressure tubing may detach from the blood sampling system",
      "recall_initiation_date": "20210526",
      "center_classification_date": "20210625",
      "termination_date": "20231214",
      "report_date": "20210707",
      "code_info": "Lot # 63456332"
    }
  ]
}