FDAClass IIMay 28, 2025

HiResolution" Bionic Ear System - M Battery Charger recall: Labeling Error

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

Why was HiResolution" Bionic Ear System - M Battery Charger recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Recalling firm
Advanced Bionics, LLC
Quantity
6 chargers
Distribution
U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A
Recall date
May 28, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls