FDA Medical devices recall ·
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 recall
- Recall number
- Z-1813-2025
- Date
- (initiated March 5, 2025)
- Company / brand
- Advanced Bionics, LLC
28515 Westinghouse Pl, Valencia, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6 chargers
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Why was it recalled?
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967
Distribution
U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A
States: Arizona Florida Michigan South Carolina Tennessee Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1813-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.