Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor ... recall (Advanced Bionics, LLC)
Medical deviceClass IIOngoing
Summary: Advanced Bionics, LLC is recalling 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.
What is being recalled
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Why
Behind-the-ear sound processer packaging label is different then included product.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Unknown
How to tell if yours is affected
Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1493-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | November 27, 2025 |
| Reported | March 11, 2026 |
| Company | Advanced Bionics, LLC |
| Company location | Valencia, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2 units |
More recalls from Advanced Bionics, LLC · all medical device recalls · recalls from November 2025