Recall Z-1813-2025— Advanced Bionics, LLC
Class II · Ongoing
Class II FDA medical device recall by Advanced Bionics, LLC, initiated 2025-03-05. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Advanced Bionics, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-05
- Firm location
- Valencia, CA, United States
Product description
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Reason for recall
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Data sourced from openFDA. This site is unofficial and independent of the FDA.