Advanced Bionics recalls
4 official recalls and safety alerts involving Advanced Bionics since 2025-05, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Advanced Bionics or the relevant agency.
- 2026-06-10
USAdvanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software…
Due to incorrect shelf-life expiration date.
FDA · DeviceAdvanced Bionics, LLCU.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD,…Official notice →- 2026-05-06
- US
Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120;…
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.
FDA · DeviceAdvanced Bionics, LLCWorldwide - U.S Nationwide distribution including in the state of AK, AL, AR,…Official notice → - 2026-03-11
- US
Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Behind-the-ear sound processer packaging label is different then included product.
- 2025-05-28
- US
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.