Class II — Advanced Bionics, LLC
| Recalling firm | Advanced Bionics LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Behind-the-ear sound processer packaging label is different then included product. |
| Product | Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150 |
| Quantity | 2 units |
| Distribution | Unknown |
| Initiated | 2025-11-27 |
| Classified | 2026-03-05 |
| Recall number | Z-1493-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Advanced Bionics, LLC (Z-1493-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98161/
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