Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90… — Class II medical device recall Z-1493-2026
Ongoing recall by Advanced Bionics, LLC, reported 2026-03-11. Behind-the-ear sound processer packaging label is different then included product.
| Recall number | Z-1493-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Bionics, LLC, Valencia, CA, United States |
| Recall initiated | 2025-11-27 |
| Classified | 2026-03-05 |
| Reported by FDA | 2026-03-11 |
| Quantity | 2 units |
| Reason classes | labeling |
| Lot numbers | 08400944CI5295YJ |
| Serial numbers | 249596, 249603 |
| Model numbers | CI-5295-150 |
Product
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Reason for recall
Behind-the-ear sound processer packaging label is different then included product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1493-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.