Valencia, CA, United States
Advanced Bionics, LLC recalls
9 recalls recorded since 2018, most recently on 30 April 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)4
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 30 April 2026
- Reason
- Due to incorrect shelf-life expiration date.
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD, MI, MO, MT, NC, TN, WA and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2283-2026
- Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochle
Ongoing Class II Medical devices
- Recall started
- 23 March 2026
- Reason
- 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.
- Distribution
- Worldwide - U.S Nationwide distribution including in the state of AK, AL, AR, AZ, CA, CO, CT, CD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Canad
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1950-2026
- Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260;
Ongoing Class II Medical devices
- Recall started
- 27 November 2025
- Reason
- Behind-the-ear sound processer packaging label is different then included product.
- Distribution
- Unknown
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1493-2026
- Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Ongoing Class II Medical devices
- Recall started
- 5 March 2025
- Reason
- Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
- Distribution
- U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1813-2025
- HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Terminated Class III Medical devices
- Recall started
- 26 September 2020
- Terminated
- 4 May 2023
- Reason
- Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0487-2021, Z-0486-2021
- AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Proce
- AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Proce
Terminated Class II Medical devices
- Recall started
- 17 February 2020
- Terminated
- 26 January 2023
- Reason
- hearing performance degradation due to body-fluid entering the device.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Brazil, Bangladesh, Switzerland, China, Australia, India, South Korea, Thailand, Ecuador, Mexico, El Salvador, Guatemala, Malaysia, Myanmar, Taiwan, Chile, Costa Rica, Colombia, Panama, Japan, Argentina, Peru, Singapore
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2033-2020, Z-2032-2020
- AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation
- AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electric
Terminated Class III Medical devices
- Recall started
- 4 April 2019
- Terminated
- 27 June 2022
- Reason
- 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.
- Distribution
- US Nationwide distribution in the sates of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, PA, SC, SD, TN, TX, VA, VT, WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1441-2020
- SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals
Terminated Class III Medical devices
- Recall started
- 18 March 2019
- Terminated
- 27 April 2021
- Reason
- 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.
- Distribution
- No US distribution OUS: Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1259-2020
- HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Terminated Class II Medical devices
- Recall started
- 6 February 2019
- Terminated
- 1 February 2024
- Reason
- The sound processors were loaded with the incorrect firmware.
- Distribution
- Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1084-2019, Z-1085-2019, Z-1083-2019
- Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
- Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
- Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.