FDA Device recall Z-1699-2014
Cochlear Baha Soft tissue gauge 6mm
- FDA Device
- Class II
- terminated
- Published 2014-06-11
On 2014-06-11 the FDA classified a Class II recall of Cochlear Baha Soft tissue gauge 6mm by Cochlear Americas, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1699-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-09 |
| Published | 2014-06-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cochlear Americas |
| Distribution | US |
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.
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.
Identifiers
| code_info | Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1699-2014%22
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