{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "San Clemente",
      "address_1": "100 Calle Iglesia",
      "reason_for_recall": "ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.",
      "address_2": "",
      "product_quantity": "114 units",
      "code_info": "Lot Number            Expiration Date  160815-001            2018-08-07  160816-001            2018-08-07  160824-003            2018-08-18  160825-001            2018-08-18  160825-002            2018-08-18",
      "center_classification_date": "20161109",
      "distribution_pattern": "US Nationwide Distribution in the states of: MO, TX, AZ, CA, NY, TN, GA, LA, FL, MA, OH, IN, IL",
      "state": "CA",
      "product_description": "ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110    product Usage:  The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.",
      "report_date": "20161116",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Reshape Medical Inc",
      "recall_number": "Z-0392-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75475",
      "termination_date": "20170124",
      "more_code_info": "",
      "recall_initiation_date": "20161014",
      "postal_code": "92672-7502",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}