REVOLVE ADVANCED ADIPOSE SYSTEM — Class II medical device recall Z-0823-2018
Terminated recall by LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC, reported 2018-03-07, distributed nationwide. Presence of bacterial endotoxins levels above the acceptable limit
| Recall number | Z-0823-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC, Branchburg, NJ, United States |
| Recall initiated | 2017-08-08 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2018-09-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, IL, JP, NZ, SG |
| Quantity | 25,798 units |
| Reason classes | microbial contamination, sterility |
Product
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
Reason for recall
Presence of bacterial endotoxins levels above the acceptable limit
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-0823-2018. 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.