CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report
Cochlear Baha Soft tissue gauge Reusable instrument used recalled
Cochlear Americas is recalling Cochlear Baha Soft tissue gauge Reusable instrument used to ensure the soft tissue, distributed nationwide in the US. The recall was initiated on 9 Apr 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1699-2014
- FDA event ID
- 68080
- Recalling firm
- Cochlear Americas, Centennial, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Apr 2014
- FDA classified
- 2 Jun 2014
- Reported
- 11 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hearing Aids
Timeline
| 9 Apr 2014 | Recall initiated by company | |
| 2 Jun 2014 | Classified by FDA | +54 days |
| 11 Jun 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cochlear Americas
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|---|---|---|---|---|---|
| Device | CLASS II | Cochlear Baha 5 Sound Processor Tamper Proof Battery Door recalled | Cochlear Americas | Packaging Defects | 10 states |
| Device | CLASS II | Cochlear Nucleus Sterile Silicone Template recalled by Cochlear Americas | Cochlear Americas | Sterility | Nationwide |
Other Hearing Aids recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits: Discectomy Pack DYNJ86476B Ear recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | See RES for full list recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled | Advanced Bionics | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Chp Cochlear Supplement Cds recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Device Malfunction | Nationwide |