Sound Processor Recall: HiResolution Sky CI M90
Announced 2026-06-10 · FDA
FDA recall involves two HiResolution Sky CI M90 Sound Processors (Model CI-5295-150) from Advanced Bionics. The recall is due to a packaging label that differs from the included product. The affected units are identified by Lot Code UDI-DI: 08400944CI5295YJ, Model CI-5295-150, and Serial Numbers 249596 and 249603; distribution is unknown and no corrective action is listed.
| Brand | Advanced Bionics, LLC |
|---|---|
| Product | Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150 |
| Reason | Behind-the-ear sound processer packaging label is different then included product. |
| Severity | moderate |
| Units affected | 36 |
| Distribution | Unknown |
| Agency | FDA |
| Recall / campaign no. | Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603 |
WHAT YOU SHOULD DO
- Stop using the affected Sky CI M90 Sound Processors and store them safely.
- Contact Advanced Bionics customer service with the model CI-5295-150, lot code UDI-DI: 08400944CI5295YJ, and serial numbers 249596 and 249603 to arrange replacement or repair.
- Follow the manufacturer's instructions for returning or exchanging the units.
- Monitor FDA updates and consult your clinician if you have questions or experience issues.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.