FDA Medical Device Recalls (openFDA)
Cochlear Americas Inc.: 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.
- Recall number
- Z-1699-2014
- Recalling firm
- Cochlear Americas Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2014-04-09
- Posted
- 2014-06-02
- Terminated
- 2014-10-06
- Reason
- 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.
- Root cause
- Process control
- Action
- Customers were notified via letter on 4/17/14. This communication included an explanation of the recall and instructions to quarantine and return products.
- Quantity
- 288
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008
- 510(k) numbers
- ["K131240"]
- PMA numbers
- not on file
- Product code
- LXB
- Firm FEI
- 3005900820
- Firm city
- Centennial
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28