Z-1813-2025Class II

HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

Name: Z-1813-2025 HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Creator: Advanced Bionics, LLC
Published: 2025-03-05
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2025-03-05 / Open, Classified / root cause: labeling and UDI

FDA source

Advanced Bionics, LLC began a recall of HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 on 2025-03-05. FDA classified it as Class II and gives the reason as "Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1813-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-05
Posted: 2025-05-22
Recalling firm: Advanced Bionics LLC
Product: HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Product code: MCM Implant, Cochlear
Reason for recall: Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Root cause tag: labeling and UDI
FDA 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 [email protected]
Quantity in commerce: 6 chargers
Distribution: U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A
Product codes and lots: M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1813-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1813-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-22

Product code MCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)