ReShape Integrated Dual Balloon System — Class II medical device recall Z-2552-2016
Terminated recall by Reshape Medical Inc, reported 2016-08-24, distributed in CA, NY, OH. Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the deli
| Recall number | Z-2552-2016 |
|---|---|
| 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 | 2016-05-04 |
| Classified | 2016-08-17 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2016-08-17 |
| Distributed | CA, NY, OH |
| Quantity | 56 units |
| Reason classes | packaging |
| Model numbers | 01-0013-001, RSM110 |
Product
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.
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.
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-2552-2016. 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.