Class II — Potential Health Hazard

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

Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to Recalled by Cochlear Americas Inc. Due to Cochlear America is recalling Cochlear Baha Soft Tissue...

Date: April 9, 2014
Company: Cochlear Americas 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 Cochlear Americas Inc. directly.

Affected Products

Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.

Quantity: 288

Why Was This Recalled?

Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cochlear Americas Inc.

Cochlear Americas Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

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