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 | Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified. |
| Product | HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 |
| Quantity | 6 chargers |
| Distribution | U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A |
| Initiated | 2025-03-05 |
| Classified | 2025-05-22 |
| Recall number | Z-1813-2025 |
| 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-1813-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96668/
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