Natrelle CUI Series Tissue Expanders — Class II medical device recall Z-2104-2015
Terminated recall by Allergan Inc, reported 2015-07-29. Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyon
| Recall number | Z-2104-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allergan Inc, Irvine, CA, United States |
| Recall initiated | 2015-06-18 |
| Classified | 2015-07-17 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2015-12-16 |
| Countries outside the US | CA |
| Lot numbers | VE7507, VE7508, VE9117, VE9272, VE9273, VE9274, VF1201, VF1420, VF1427, VF3627, VF4561, VF4923, VF5340, VF5341, VF5396 |
| Serial numbers | VE7507, VE7508, VE9117, VE9272, VE9273, VE9274, VF1201, VF1420, VF1427, VF3627, VF4561, VF4923, VF5340, VF5341, VF5396 |
Product
Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.
Reason for recall
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.
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-2104-2015. 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.