{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Irvine",
      "address_1": "1 Edwards Way",
      "reason_for_recall": "SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.",
      "address_2": "",
      "product_quantity": "1 Valve",
      "code_info": "Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731",
      "center_classification_date": "20180713",
      "distribution_pattern": "NJ",
      "state": "CA",
      "product_description": "Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm",
      "report_date": "20180725",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Edwards Lifesciences, LLC",
      "recall_number": "Z-2435-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80394",
      "termination_date": "20190523",
      "more_code_info": "",
      "recall_initiation_date": "20180611",
      "postal_code": "92614-5688",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}