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Advanced Bionics Recalls
14 recalls on record · October 31, 2012 to June 10, 2026 · Medical Devices
Recalls by year
12
19
20
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 10, 2026Medical DevicesFDA
Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI
Hazard: Due to incorrect shelf-life expiration date.
May 6, 2026Medical DevicesFDA
Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5
Hazard: 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.
March 11, 2026Medical DevicesFDA
Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Hazard: Behind-the-ear sound processer packaging label is different then included product.
May 28, 2025Medical DevicesFDA
Advanced Bionics, LLC recalls HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Hazard: Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
December 2, 2020Medical DevicesFDA
Advanced Bionics, LLC recalls AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI
Hazard: Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
December 2, 2020Medical DevicesFDA
Advanced Bionics, LLC recalls AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI
Hazard: Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
May 27, 2020Medical DevicesFDA
Advanced Bionics, LLC recalls AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a lev
Hazard: hearing performance degradation due to body-fluid entering the device.
May 27, 2020Medical DevicesFDA
Advanced Bionics, LLC recalls AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to
Hazard: hearing performance degradation due to body-fluid entering the device.
March 11, 2020Medical DevicesFDA
Advanced Bionics, LLC recalls SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWav
Hazard: The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed installation has not impact to the current version of the software, and users are able to continue programming devices with the current software version.
February 26, 2020Medical DevicesFDA
Advanced Bionics, LLC recalls HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Hazard: Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
April 10, 2019Medical DevicesFDA
Advanced Bionics, LLC recalls Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
Hazard: The sound processors were loaded with the incorrect firmware.
April 10, 2019Medical DevicesFDA
Advanced Bionics, LLC recalls Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-
Hazard: The sound processors were loaded with the incorrect firmware.
April 10, 2019Medical DevicesFDA
Advanced Bionics, LLC recalls Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-
Hazard: The sound processors were loaded with the incorrect firmware.
October 31, 2012Medical DevicesFDA
Advanced Bionics Corporation recalls HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant sy
Hazard: Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.