Medical DeviceJun 10, 2026
HiResolution" Bionic Ear System HiRes Ultra 3D CI HiFocus Mid Scala recall — FDA Z-2283-2026
Due to incorrect shelf-life expiration date.
Class IIFDA: OngoingAdvanced Bionics, LLC
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceMay 6, 2026
HiResolution" Bionic Ear System M Zn-Air Battery Pak recall — FDA Z-1950-2026
The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.
Class IIFDA: OngoingAdvanced Bionics, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies Advanced Bionics, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.