Class II — Potential Health Hazard

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

Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Recalled by Allergan Inc Due to Allergan is recalling the NATRELLE 133 and CUI...

Date: June 18, 2015
Company: Allergan Inc
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 Allergan Inc directly.

Affected Products

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.

Quantity: 23 units total (16 units in US)

Why Was This Recalled?

Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.

Where Was This Sold?

US in the state of Canada

About Allergan Inc

Allergan Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

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