FDA DevicesClass II
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Proce...
Published: March 11, 2026Recall ID: Z-1493-2026Category: devicesCountry: US
Reason for Recall / Hazard
Behind-the-ear sound processer packaging label is different then included product.
Product Description & Identification
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Affected Products
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Additional Source Details
| Field | Value |
|---|---|
| City | Valencia |
| State | CA |
| Event id | 98161 |
| Address 1 | 28515 Westinghouse Pl |
| Address 2 | N/A |
| Code info | Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603 |
| Postal code | 91355-1398 |
| Report date | 20260311 |
| Product type | Devices |
| Product quantity | 2 units |
| Reason for recall | Behind-the-ear sound processer packaging label is different then included product. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251127 |
| Initial firm notification | Letter |
| Center classification date | 20260305 |
Overview
- Recalling FirmAdvanced Bionics, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUnknown