{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irwindale",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78129",
      "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, Japan, Canada, Australia, New Zealand, Brazil, Croatia, Korea, Austria, Colombia, Italy, Portugal, Argentina, South Africa, Belgium, France, Germany, Ireland, Poland, Netherlands, Sweden, Denmark, Finland, Switzerland, Great Britain, Hungary, Czech Republic, China",
      "recall_number": "Z-0054-2018",
      "product_description": "THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S",
      "product_quantity": "357 units",
      "reason_for_recall": "Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a \"Map: magnetic distortion\" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.",
      "recall_initiation_date": "20170906",
      "center_classification_date": "20171027",
      "termination_date": "20191119",
      "report_date": "20171108",
      "code_info": "17682851L 17682730L 17685880L 17685740L  17685692L 17680131L 1768581 lL 17685897L  17685789L 17676998L 17685889L 17685896L  17685792L 17685741L 17685758L 17685846L  17689428L 17689420L 17685881L 17680081L  17689454L 17682788L 17685853L 17685750L  17692068L 17689430L 17680080L 17682787L  17692069L 17689463L 17689421L 17685691L"
    }
  ]
}