FDA Device recall Z-2591-2014
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722
- FDA Device
- Class II
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class II recall of EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722 by Mentor Texas, citing the device labeling is stamped with 330cc and the device is actually 380cc device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2591-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-02 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mentor Texas |
| Distribution | US |
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
The device labeling is stamped with 330cc and the device is actually 380cc device.
Identifiers
| code_info | Part Number (PN) 351-3380SZ Lot Number 6830722 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Mentor Texas
- SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
FDA Device · Class II · 2026-07-08 · Mentor Texas - Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High &…
FDA Device · Class II · 2026-04-08 · Mentor Texas - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
FDA Device · Class II · 2026-04-08 · Mentor Texas - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tiss…
FDA Device · Class II · 2026-04-08 · Mentor Texas - Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Prof…
FDA Device · Class II · 2026-04-08 · Mentor Texas
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2591-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.