Advanced Bionics, LLC: Medical Device Recall in 2025 - (Recall #: Z-1813-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 5, 2025

Date Posted: May 28, 2025

Recall Number: Z-1813-2025

Event ID: 96668

Reason for Recall:

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

Status: Ongoing

Product Quantity: 6 chargers

Code Information:

M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated