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: 7, Class III: 4.
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
Medical DeviceDec 2, 2020
Advanced Bionics AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 recall — FDA Z-0487-2021
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Class IIIFDA: TerminatedAdvanced Bionics, LLC
Medical DeviceDec 2, 2020
Advanced Bionics AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 recall — FDA Z-0486-2021
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Class IIIFDA: TerminatedAdvanced Bionics, LLC
Medical DeviceMay 27, 2020
Advanced Bionics AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product recall — FDA Z-2033-2020
hearing performance degradation due to body-fluid entering the device.
Class IIFDA: TerminatedAdvanced Bionics, LLC
Medical DeviceMay 27, 2020
Advanced Bionics AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ recall — FDA Z-2032-2020
hearing performance degradation due to body-fluid entering the device.
Class IIFDA: TerminatedAdvanced Bionics, LLC
Medical DeviceMar 11, 2020
Advanced Bionics SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN recall — FDA Z-1441-2020
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…
Class IIIFDA: TerminatedAdvanced Bionics, LLC
Medical DeviceFeb 26, 2020
Advanced Bionics HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode recall — FDA Z-1259-2020
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…
Class IIIFDA: TerminatedAdvanced Bionics, LLC
Medical DeviceApr 10, 2019
Advanced Bionics Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120 recall — FDA Z-1084-2019
The sound processors were loaded with the incorrect firmware.
Class IIFDA: TerminatedAdvanced Bionics, LLC
Medical DeviceApr 10, 2019
Advanced Bionics Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140 recall — FDA Z-1085-2019
The sound processors were loaded with the incorrect firmware.
Class IIFDA: TerminatedAdvanced Bionics, LLC
Medical DeviceApr 10, 2019
Advanced Bionics Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120 recall — FDA Z-1083-2019
The sound processors were loaded with the incorrect firmware.
Class IIFDA: TerminatedAdvanced 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.