Cochlear Baha Soft tissue gauge 6mm — Class II medical device recall Z-1699-2014
Terminated recall by Cochlear Americas Inc., reported 2014-06-11, distributed nationwide. Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in th
| Recall number | Z-1699-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cochlear Americas Inc., Centennial, CO, United States |
| Recall initiated | 2014-04-09 |
| Classified | 2014-06-02 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2014-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 288 |
| Lot numbers | 131008, COH484221, COH485876, COH523440 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1699-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.