Cochlear Americas Inc.: Medical Device Recall in 2014 - (Recall #: Z-1699-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 9, 2014

Date Posted: June 11, 2014

Recall Number: Z-1699-2014

Event ID: 68080

Reason for Recall:

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.

Status: Terminated

Product Quantity: 288

Code Information:

Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated