Medical device recalls Moderate risk

Advanced Bionics, LLC recalls HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

Recall date
March 5, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1813-2025
FDA classification
Class II
Brand / firm
Advanced Bionics, LLC
Sold / distributed
U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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