HiResolution Bionic Ear Battery Charger (Advanced Bionics) – Incorrect Packaging (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Brand
Advanced Bionics, LLC
Lot Codes / Batch Numbers
M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966, 410488967
Products Sold
M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967
Advanced Bionics, LLC is recalling HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 due to Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, FL, MI, SC, TN, TX
Page updated: Jan 10, 2026