FDA-Device2026-03-11Class IIMISBRANDING
Advanced Bionics Sky CI M90 Sound Processor recalled for mislabeled packaging
What this means
Advanced Bionics is recalling certain Sky CI M90 Sound Processors because the label on the package does not match the product inside. Two units with specific serial numbers (249596 and 249603) are affected. No injuries have been reported.
- Check if your Sky CI M90 Sound Processor has serial number 249596 or 249603
- Compare the product packaging label to the actual device inside
- Contact Advanced Bionics or your healthcare provider if you have one of the affected units
The agency's original wording
Hazard
Behind-the-ear sound processer packaging label is different then included product.
Intended for
All ages
Illnesses reported
None reported
Sold states
Unknown
Affected count
2 units
Manufactured in
28515 Westinghouse Pl, N/A, Valencia, CA, United States
Products
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1493-2026Want us to check the next one for you?
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