Advanced Bionics, LLC: Device Recall
Recall #Z-1813-2025 · 03/05/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1813-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Advanced Bionics, LLC
- Status
- Ongoing
- Date Initiated
- 03/05/2025
- Location
- Valencia, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 chargers
Reason for Recall
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Product Description
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Distribution Pattern
U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.