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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