{
  "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": "Flagstaff",
      "state": "AZ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88721",
      "recalling_firm": "W L Gore & Associates, Inc.",
      "address_1": "3750 W Kiltie Ln",
      "address_2": "N/A",
      "postal_code": "86005-8712",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "International distribution to the countries of Italy & Lebanon.",
      "recall_number": "Z-0077-2022",
      "product_description": "Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS,  REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:",
      "product_quantity": "2 units",
      "reason_for_recall": "Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain  a 9mm x 29 mm x 135 cm device.",
      "recall_initiation_date": "20210907",
      "center_classification_date": "20211008",
      "report_date": "20211020",
      "code_info": "Serial Numbers: 22753580"
    }
  ]
}