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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

HiResolution Bionic Ear System M Battery Chargers Recalled for Mislabeling

Agency Publication Date: May 22, 2025
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Summary

Advanced Bionics, LLC is recalling six HiResolution Bionic Ear System - M Battery Chargers (Model CI-5607) because the incorrect charger was placed inside the packaging. This error means the label on the outside of the box does not match the actual product inside. No incidents or injuries have been reported to date.

Risk

The product labeling does not match the device inside the package. Using an incorrect battery charger could result in improper charging or potential damage to the battery of the bionic ear system, which may affect the device's performance.

What You Should Do

  1. This recall affects the HiResolution Bionic Ear System - M Battery Charger (Model CI-5607) with UDI-DI code 00840094433977 and lot numbers 410488966 or 410488967.
  2. Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Advanced Bionics, LLC for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: HiResolution Bionic Ear System - M Battery Charger
Model / REF:
CI-5607
Lot Numbers:
410488966
410488967
UDI:
00840094433977

Quantity: 6 chargers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96668
Status: Active
Manufacturer: Advanced Bionics, LLC
Sold By: Advanced Bionics authorized distributors
Manufactured In: United States
Units Affected: 6 chargers
Distributed To: Arizona, Florida, Michigan, South Carolina, Tennessee, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.