{
  "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": [
    {
      "status": "Terminated",
      "city": "Phoenix",
      "state": "AZ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85379",
      "recalling_firm": "W. L. Gore & Associates Inc.",
      "address_1": "32360 N North Valley Pkwy",
      "address_2": "N/A",
      "postal_code": "85085-4228",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "All distribution is foreign to the following countries:  Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Norway, Spain, Sweden, Switzerland, and the UK.",
      "recall_number": "Z-1962-2020",
      "product_description": "Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile.  The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.",
      "product_quantity": "141 devices",
      "reason_for_recall": "The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.",
      "recall_initiation_date": "20191118",
      "center_classification_date": "20200511",
      "termination_date": "20200513",
      "report_date": "20200520",
      "code_info": "Serial numbers 21077298, 21077364, 21077365, 21077366, 21077631, 21077350, 21077351, 21077414, 21060888, 21077339, 21077340, 21077341, 21077417, 21077418, 21061626, 21077286, 21077336, 21077337, 21077211, 21077304, 21077305, 21077307, 21077308, 21077309, 21077640, 21077559, 21077563, 21077564, 21077183, 21077346, 21077347, 21077616, 21077617, 21077618, 21077619, 21077419, 21077596, 21077345, 21077620, 21077635, 21077322, 21077602, 21077362, 21077622, 21077623, 21077624, 21077625, 21077626, 21077627, 21077628, 21077348, 21077349, 21077633, 21077644, 21077363, 21077352, 21077634, 21077621, 21077318, 21077319, 21061622, 21077590, 21077591, 21077629, 21077632, 21060886, 21077593, 21077594, 21077274, 21077282, 21077338, 21077636, 21077637, 21077638, 21077639, 21077642, 21077643, 21061625, 21061627, 21077601, 21077608, 21077284, 21077303, 21077320, 21077321, 21077316, 21077415, 21077416, 21077299, 21077300, 21077301, 21077302, 21077369, 21077342, 21077599, 21077600,   21077197, 21077595, 21061623, 21077641, 21077597, 21061624, 21077285,   21077184, 21077185, 21077609, 21077436, 21077437, 21077592, 21077190, 21077191, 21077192, 21077193, 21077194, 21077195, 21077196, 21077206, 21077207, 21077208, 21077561, 21077562, 21077367, 21077368, 21077188, 21077630, 21077186, 21077187, 21077189, 21077310, 21077317, 21077334, 21077353, 21077605, 21077343, 21077344, 21077177, 21077178, 21077179, 21077180, 21077181, and 21077598."
    }
  ]
}