{
  "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": "San Clemente",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "74781",
      "recalling_firm": "Reshape Medical Inc",
      "address_1": "100 Calle Iglesia",
      "address_2": "N/A",
      "postal_code": "92672-7502",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: Distribution to the states of :  NY, OH and CA.",
      "recall_number": "Z-2552-2016",
      "product_description": "ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001    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 obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.",
      "product_quantity": "56 units",
      "reason_for_recall": "Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter.  The possible misalignment is the result of an assembly error during manufacturing and may lead to leakage of saline solution during the balloon inflation procedure.",
      "recall_initiation_date": "20160504",
      "center_classification_date": "20160817",
      "termination_date": "20160817",
      "report_date": "20160824",
      "code_info": "160317-001, 160371-002, 160317-003, 160324-010."
    }
  ]
}