{
  "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": "75012",
      "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": "International Distribution to China, Hong Kong and Brazil.",
      "recall_number": "Z-2776-2016",
      "product_description": "CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 ,  v 4.3 and v 2.3.  The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.",
      "product_quantity": "338 units",
      "reason_for_recall": "Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).",
      "recall_initiation_date": "20160815",
      "center_classification_date": "20160909",
      "termination_date": "20170120",
      "report_date": "20160921",
      "code_info": "V 3.2: 2258, 10284, 10332, 10345, 11640, 11642, 60011, 60012, 60606, 60611, 60613, 60618, 60621, 60625, 60634, 60644, 60651, 60654, 60657, 60658, 60660, 60661, 60664, 60671, 60673, 60674, 60680, 60682, 60683, 61000, 61002, 61005, 61010, 61014, 61038, 61039, 61041, 61045, 61046, 61050, 61055, 61060, 61062, 61064, 61071, 61501, 66114, 66115, 66117, 66118, 66119, 29306, 13173, 13213, 11567, 14528    V 4.3: 61053, 61054, 61059, 11701, 12664    V 2.3: 14218, 13208, 50203, 50531, 14718, 50573",
      "more_code_info": ""
    }
  ]
}