ReShape Integrated Dual Balloon System — Class II medical device recall Z-0392-2017
Terminated recall by Reshape Medical Inc, reported 2016-11-16, distributed nationwide. ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillatio
| Recall number | Z-0392-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reshape Medical Inc, San Clemente, CA, United States |
| Recall initiated | 2016-10-14 |
| Classified | 2016-11-09 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2017-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 114 units |
| Reason classes | packaging |
| Lot numbers | 160815-001, 160816-001, 160824-003, 160825-001, 160825-002 |
| Model numbers | 01-0013-001, RSM110 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0392-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.