{
  "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": [
    {
      "country": "United States",
      "city": "Sunnyvale",
      "address_1": "540 Oakmead Pkwy",
      "reason_for_recall": "Potential failure of HALO Energy Generator to enter \"stand by\" mode when initially powered on; and therefore can not be used for patient care.",
      "address_2": "",
      "product_quantity": "617 generators",
      "code_info": "Model numbers 1190A-115A and 1190A-230A; all serial numbers.",
      "center_classification_date": "20120914",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and the countries of  Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Jordan, Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Venezuela and UK.",
      "state": "CA",
      "product_description": "HALO Flex Energy Generators    Manufactured by B¿RRX Medical (now Covidien)  540 Oakmead Parkway  Sunnyvale, CA 95085.    The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, including Barrett's Esophagus.",
      "report_date": "20120926",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Covidien LLC",
      "recall_number": "Z-2379-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62867",
      "termination_date": "20130930",
      "more_code_info": "",
      "recall_initiation_date": "20120803",
      "postal_code": "94085-4022",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}