{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Houston",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84710",
      "recalling_firm": "LivaNova USA Inc",
      "address_1": "100 Cyberonics Blvd",
      "address_2": "",
      "postal_code": "77058-2069",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "US:  FL, GA, KS, MO, and UT.    No OUS distribution",
      "recall_number": "Z-1118-2020",
      "product_description": "VNS Therapy SENTIVA  Generator Model # 1000    Labeling  26-0009-6800 Model 1000 Generator Sample Labels  26-0009-9600 Patient s Manual for Depression  26-0009-9500 Patient s Manual for Epilepsy  76-0000-5000 VNS Therapy System Physician s Manual  (refer to Attachment 1)",
      "product_quantity": "6 generators",
      "reason_for_recall": "Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.",
      "recall_initiation_date": "20190813",
      "center_classification_date": "20200210",
      "termination_date": "20220518",
      "report_date": "20200219",
      "code_info": "Model           Serial No.  UDI  Model 1000  204460      01054250257504051119080317201205212044609910-0011-6102    Model 1000  183960      01054250257504051119080217200912211839609910-0011-6102    Model 1000  194980      01054250257504051119080217201030211949809910-0011-6102    Model 1000  204700      01054250257504051119080217201205212047009910-0011-6102    Model 1000  206720      01054250257504051119080317201219212067209910-0011-6102    Model 1000  213290      01054250257504051119080517210108212132909910-0011-6102",
      "more_code_info": ""
    }
  ]
}