FDA Device recall Z-1493-2026
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
- FDA Device
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150 by Advanced Bionics, citing behind-the-ear sound processer packaging label is different then included product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1493-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-27 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Advanced Bionics |
| Distribution | n/a |
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.
Identifiers
| code_info | Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1493-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.