Advanced Bionics, LLC recalls HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

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

On 03/06/2025, customer service informed customers via telephone call of a distribution error. An updated "URGENT: Medical Device Recall Notification will be communicated to customers on or about 04/09/2025, via email. This updated notification will inform them that upon further review/investigation, it was identified that the individual package label was for the Marvel M Battery Charger (CI-5607), however the product within the package was a Naida CI PowerCel Charger (CI-5605). Customer are informed that: 1. The mislabeled battery charger they received was from lot either Lot Numbers: 410488967 and/or 410488966 Customers are instructed to: 2. Return the affected chargers to Advance Bionics. Advance Bionics will provide the correct charger to customer and will confirm receipt and return of the affected chargers. For questions contact customer service at 877-829-0026 or email Customerservice@advancebionics.com

• FDA enforcement recordOfficial FDA database entry for Z-1813-2025
• FDA device classification · MCMOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Advanced Bionics, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.