FDA Device recall Z-1813-2025
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
- FDA Device
- Class II
- ongoing
- Published 2025-05-28
On 2025-05-28 the FDA classified a Class II recall of HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 by Advanced Bionics, citing due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1813-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-05 |
| Published | 2025-05-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Advanced Bionics |
| Distribution | AZ, FL, MI, SC, TN, TX |
Product
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Reason
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Identifiers
| code_info | M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1813-2025%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.