Advanced Bionics, LLC FDA Recalls

4 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CIClass IIApr 30, 2026Due to incorrect shelf-life expiration date.	Due to incorrect shelf-life expiration date.	Class IIDevices	Apr 30, 2026
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5Class IIMar 23, 2026The non-tamperproof battery door supplied with the sound pro	The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by	Class IIDevices	Mar 23, 2026
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150Class IINov 27, 2025Behind-the-ear sound processer packaging label is differen	Behind-the-ear sound processer packaging label is different then included product.	Class IIDevices	Nov 27, 2025
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607Class IIMar 5, 2025Due to incorrect the battery charger being packaged and dist	Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the inte	Class IIDevices	Mar 5, 2025