Cochlear Baha Soft tissue gauge 6mm recallZ-1699-2014 · Cochlear Americas Inc. · initiated Apr 9, 2014
Class II Terminated All recalls posted in June 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cochlear Americas Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
Customers were notified via letter on 4/17/14. This communication included an explanation of the recall and instructions to quarantine and return products.
Recall details
- Recall number
- Z-1699-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 9, 2014
- Posted by the FDA
- Jun 2, 2014
- Recalling firm
- Cochlear Americas Inc.
- Quantity
- 288
- Product code
- LXB
- FDA submissions
- K131240
- Distribution
- Nationwide Distribution.
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.
Code information (models, lots, serial numbers)
Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008
Other devices under the same FDA submission
7 devices cleared under K131240 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SP Magnet 3 95773Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction9 reports
- SP Magnet 4 95774Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction3 reports
- Baha 94125Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction2 reports
- SP Magnet 1 95771Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction2 reports
- SP Magnet 6 95776Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction1 report
- SP Magnet 5 95775Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction1 report
- SP Magnet 2 95772Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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