Class II — Potential Health Hazard

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

CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue Recalled by Mentor Texas, LP. Due to The CPX4 Tissue Expander may have been packaged...

Date: August 9, 2016
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

CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

Quantity: 30 units

Why Was This Recalled?

The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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