Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast Recalled by Mentor Texas, LP. Due to The IFU provided in the affected units of...

Date: December 11, 2014
Company: Mentor Texas, LP.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mentor Texas, LP. directly.

Affected Products

MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.

Quantity: 45 units

Why Was This Recalled?

The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.

Where Was This Sold?

This product was distributed to 17 states: CA, FL, GA, IL, KS, ME, MA, NJ, NY, NC, OR, PA, TN, TX, WA, WV, WI

Affected (17 states)Not affected

About Mentor Texas, LP.

Mentor Texas, LP. has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report