{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irwindale",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90647",
      "recalling_firm": "Biosense Webster, Inc.",
      "address_1": "15715 Arrow Hwy",
      "address_2": "N/A",
      "postal_code": "91706-2006",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME, FL, IA, NM, NH, TN, WI, OH, SC, CA, IN.",
      "recall_number": "Z-1677-2022",
      "product_description": "CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501.  Used to introduce various cardiovascular catheters into the heart.",
      "product_quantity": "98",
      "reason_for_recall": "Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside.  Devices with a compromised sterile barrier could be a source for infection.",
      "recall_initiation_date": "20220629",
      "center_classification_date": "20220902",
      "report_date": "20220914",
      "code_info": "UDI-DI: 10846835016253, Lot Number: 00002001"
    }
  ]
}