The Recall Desk
ModerateFDA (Devices)·Z-1813-2025·Announced 2025-05-28

Advanced Bionics Battery Charger Model CI-5607 Recalled for Incorrect Packaging and Labeling

Advanced Bionics recalls 6 M Battery Chargers (Model CI-5607) due to incorrect packaging and labeling that does not match the intended product.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a labeling and packaging mismatch without documented harm, meeting the criteria for Moderate severity.

Plain-English summary

Advanced Bionics, LLC is recalling 6 units of the HiResolution Bionic Ear System - M Battery Charger, Model Number CI-5607 (UDI-DI code 00840094433977). The affected units include Lot Numbers 410488966 and 410488967, distributed in Arizona, Florida, Michigan, South Carolina, Tennessee, and Texas.

The recall is issued because the battery charger was packaged and distributed incorrectly. The product labeling does not match the intended product as specified by the manufacturer.

The recalled product

Product
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Manufacturer
Advanced Bionics, LLC
Hazard
  • mis-labeling
  • product-mismatch

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 410488967

Distribution

Distributed in 6 states:

  • AZ
  • FL
  • MI
  • SC
  • TN
  • TX