Class II

Medical Device Recall: HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

Advanced Bionics, LLC · March 5, 2025

Reason for Recall

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

Distribution

U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A

States Affected

AZ, FL, MI, SC, TN, TX

Quantity Affected

6 chargers

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1813-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.