Class IIOngoingZ-2283-2026
Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mi…
Due to incorrect shelf-life expiration date.
Advanced Bionics, LLCCAJun 10, 2026
Implant, Cochlear recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–4 of 4 recalls
Class IIOngoingZ-1950-2026
Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/…
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.
Advanced Bionics, LLCCAMay 6, 2026
Class IIOngoingZ-1493-2026
Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor M…
Behind-the-ear sound processer packaging label is different then included product.
Advanced Bionics, LLCCAMar 11, 2026
Class IIOngoingZ-1813-2025
Advanced Bionics, LLC recalls HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Advanced Bionics, LLCCAMay 28, 2025