Advanced Bionics, LLC Recalls

All product recalls associated with Advanced Bionics, LLC.

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Recall Summary

Total Recalls

9

Past Year

1

Class I (Serious)

0

Most Recent

Mar 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

HiResolution Bionic Ear Battery Charger (Advanced Bionics) – Incorrect Packaging (2025)

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

FDAMar 5, 2025AZ, FL, MI +3 more• Advanced Bionics, LLC

Advanced Bionics, LLC: AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (0...

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

FDASep 26, 2020Nationwide• Advanced Bionics, LLC

Advanced Bionics, LLC: AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (0...

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

FDASep 26, 2020

Nationwide

• Advanced Bionics, LLC

Advanced Bionics, LLC: AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiF...

hearing performance degradation due to body-fluid entering the device.

FDAFeb 17, 2020Nationwide• Advanced Bionics, LLC

Advanced Bionics LLC: Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-14...

The recall was initiated after Advanced Bionics became aware of fourteen (14) devices manufactured between May 27, 2005 and June 30, 2005 that are confirmed to have or potentially have an issue related to the internal magnet. These devices are were made with an internal magnet where the metal case surrounding the magnet was not properly welded. Patients with these devices may experience a decreas

FDAJun 10, 2009Nationwide• Advanced Bionics LLC

Advanced Bionics LLC: Platinum Series Headpiece Model Number AB-7300. The head...

Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but can

FDAJul 24, 2008Nationwide• Advanced Bionics LLC

Advanced Bionics LLC: HR90K Platinum Series Headpiece Model Number AB-7300-001 ...

Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but cann

FDAJul 24, 2008Nationwide• Advanced Bionics LLC

Advanced Bionics LLC: S-Series Long Range Headpiece Model Number AB-5301-00 (be...

Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but can

FDAJul 24, 2008Nationwide• Advanced Bionics LLC

Advanced Bionics LLC: S-Series Short Range Headpiece Model Number MMT-5300-00 (...

Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but cann

FDAJul 24, 2008Nationwide• Advanced Bionics LLC

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Advanced Bionics, LLC Recalls

Recall Summary

HiResolution Bionic Ear Battery Charger (Advanced Bionics) – Incorrect Packaging (2025)

Advanced Bionics, LLC: AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (0...

Advanced Bionics, LLC: AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (0...

Advanced Bionics, LLC: AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiF...

Advanced Bionics LLC: Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-14...

Advanced Bionics LLC: Platinum Series Headpiece Model Number AB-7300. The head...

Advanced Bionics LLC: HR90K Platinum Series Headpiece Model Number AB-7300-001 ...

Advanced Bionics LLC: S-Series Long Range Headpiece Model Number AB-5301-00 (be...

Advanced Bionics LLC: S-Series Short Range Headpiece Model Number MMT-5300-00 (...