FDA recall, , Moderate risk
Advanced Bionics HiResolution Bionic Ear System Sky CI M90 Sound Processor
The Sky CI M90 Sound Processor has a packaging label that differs from the included product.
Summary by Recall Canary from the FDA notice
What happened
Advanced Bionics, LLC, of Valencia, California, recalled the Sky CI M90 Sound Processor, part of the HiResolution Bionic Ear System, model CI-5295-150, because the behind-the-ear sound processor packaging label is different than the included product. The company began the recall on November 27, 2025. The recall was added to the FDA's Enforcement Report on March 5, 2026, and in the FDA's weekly enforcement report on March 11, 2026. Distribution is unknown.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number matches.
Sky CI M90 Sound Processor
- Model number
- CI-5295-150
Recall details
- Company began the recall
- Sold in
Unknown
- Company
- Advanced Bionics, LLCValencia, California
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98161
- Recall number
- Z-1493-2026
- Quantity recalled
- 2 units
All recalls from Advanced Bionics, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
