{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "150463",
      "product_res_number": "Z-0392-2017",
      "event_date_initiated": "2016-10-14",
      "event_date_posted": "2016-11-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-01-24",
      "res_event_number": "75475",
      "product_code": "LTI",
      "pma_numbers": [
        "P140012S002"
      ],
      "product_description": "ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110\n\nproduct Usage:\nThe 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.",
      "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",
      "firm_fei_number": "3013508647",
      "recalling_firm": "Reshape Medical Inc",
      "address_1": "100 Calle Iglesia",
      "city": "San Clemente",
      "state": "CA",
      "postal_code": "92672-7502",
      "additional_info_contact": "949-429-6680 Ext. 106",
      "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.",
      "root_cause_description": "Device Design",
      "action": "ReShape sent a customer notification letter dated October 14, 2016 was sent to customers to inform them that ReShape Medical is recalling the Integrated Dual Balloon System due to customer reports of instillation fluid leaking during the device inflation procedure.  The letter informs the customers that any instillation fluid leakage during the inflation process will cause an incomplete balloon fill and require immediate removal of the device.  Customers are instructed to contact ReShape Medical Customer Service at (844) 9377374 for any questions related to the product returns.",
      "product_quantity": "114 units",
      "distribution_pattern": "US Nationwide Distribution in the states of: MO, TX, AZ, CA, NY, TN, GA, LA, FL, MA, OH, IN, IL",
      "openfda": {
        "pma_number": [
          "P190012",
          "P160001",
          "P250023",
          "P070009",
          "P140008",
          "P180024",
          "P840025",
          "P140012",
          "P000008"
        ],
        "registration_number": [
          "3011299930",
          "3012638928",
          "3007695959",
          "2025182",
          "3000296634",
          "3013508647",
          "3005099803",
          "3003744503",
          "1018470",
          "1220477",
          "1222928"
        ],
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          "3011299930",
          "3007695959",
          "2025182",
          "3000296634",
          "3013508647",
          "3005099803",
          "3003744503",
          "1000120613",
          "1220477",
          "3015409025"
        ],
        "device_name": "Implant, Intragastric For Morbid Obesity",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}