FDA Medical Device Recalls (openFDA)
Advanced Bionics, LLC: HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
- Recall number
- Z-1813-2025
- Recalling firm
- Advanced Bionics, LLC
- Product
- HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
- Status
- Open, Classified
- Initiated
- 2025-03-05
- Posted
- 2025-05-22
- Terminated
- not on file
- Reason
- Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 6 chargers
- Distribution
- U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A
- Lot, serial or model codes
- M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967
- 510(k) numbers
- not on file
- PMA numbers
- ["P960058"]
- Product code
- MCM
- Firm FEI
- 1000220815
- Firm city
- Valencia
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28