EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer… — Class II medical device recall Z-2591-2014
Terminated recall by Mentor Texas, LP., reported 2014-09-10, distributed nationwide. The device labeling is stamped with 330cc and the device is actually 380cc device.
| Recall number | Z-2591-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mentor Texas, LP., Irving, TX, United States |
| Recall initiated | 2014-07-02 |
| Classified | 2014-09-04 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2015-04-06 |
| Distributed | Nationwide (US) |
| Quantity | 34 units |
| Reason classes | labeling |
| Lot numbers | 6830722 |
| Model numbers | 351-3380SZ, 380, 6830722EN |
Product
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.
Reason for recall
The device labeling is stamped with 330cc and the device is actually 380cc device.
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-2591-2014. 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.