The Recall Desk

Manufacturer

Advanced Bionics, LLC

13 recalls in our database name Advanced Bionics, LLC as the manufacturing or recalling firm.

What the numbers show

Total
13
Critical
0
Severe
0
Most recent
2026-06-10

Of the 13 recalls from Advanced Bionics, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–13 of 13

  • ModerateFDA (Devices)·Z-2283-2026·2026-06-10

    HiRes Ultra 3D cochlear implants carry an incorrect expiration date

    HiRes Ultra 3D CI HiFocus Mid Scala cochlear implants are being recalled due to an incorrect shelf-life expiration date. 36 units are affected.

    Product
    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 cochlear implant designed to provide useful hearing to individuals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1950-2026·2026-05-06

    HiResolution Bionic Ear Battery Pak Fails Safety Door Compliance

    Advanced Bionics is recalling HiResolution Bionic Ear System M Zn-Air Battery Paks because the non-tamperproof battery door does not require a tool to open, violating safety standards. The issue affects 45,173 units distributed worldwide.

    Product
    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; CI-5501-270; CI-5501-280 Software Version: Not Applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1493-2026·2026-03-11

    Advanced Bionics sound processor packaging label does not match contents

    Advanced Bionics is recalling two Sky CI M90 Sound Processors because the behind-the-ear sound processor packaging label differs from the product included in the pack.

    Product
    Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1813-2025·2025-05-28

    HiResolution Bionic Ear System M Battery Charger Labeling Mismatch Recall

    Advanced Bionics, LLC is recalling six units of the HiResolution Bionic Ear System - M Battery Charger (Model CI-5607) due to incorrect product labeling that does not match the intended product.

    Product
    HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0486-2021·2020-12-02

    Advanced Bionics Recalls Mislabelled PowerCel 230 Cochlear Implant Batteries

    Advanced Bionics is recalling 53 PowerCel 230 batteries for cochlear implants because they may be mislabeled with incorrect battery life information.

    Product
    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 Processor (CI-5260) for cochlear implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0487-2021·2020-12-02

    Advanced Bionics Recalls 28 Mislabelled Cochlear Implant Batteries

    Advanced Bionics is recalling 28 AB PowerCel 170 batteries due to mislabeling that may indicate incorrect battery life.

    Product
    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 Processor (CI-5260). For cochlear implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2020·2020-05-27

    Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Entry

    Advanced Bionics is recalling 8,159 HiResolution Bionic Ear Systems because body fluid may enter the device, causing hearing performance degradation.

    Product
    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 electrical stimulation of the auditory nerve.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2033-2020·2020-05-27

    Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Ingress

    Advanced Bionics is recalling HiResolution Bionic Ear Systems because body fluid can enter the device, causing hearing performance degradation.

    Product
    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 of the auditory nerve.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1441-2020·2020-03-11

    Advanced Bionics Recalls SoundWave Professional Suite Software 3.2

    Advanced Bionics is recalling SoundWave Professional Suite Software 3.2 because the installation process fails when using the supplied USB drive, though current software versions remain functional.

    Product
    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 to program Advanced Bionics sound processors for use with A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1259-2020·2020-02-26

    Advanced Bionics Cochlear Implant Electrode Recalled for Documentation Error

    Advanced Bionics is recalling four HiResolution Bionic Ear System electrodes in Japan because three materials were omitted from the approved bio-compatibility list.

    Product
    HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1083-2019·2019-04-10

    Advanced Bionics Recalls Four Naída CL Q30 Sound Processors

    Advanced Bionics is recalling four Naída CL Q30 sound processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.

    Product
    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.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1084-2019·2019-04-10

    Advanced Bionics Recalls Three Naída CI Q70 Sound Processors

    Advanced Bionics is recalling three Naída CI Q70 Sound Processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.

    Product
    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.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1085-2019·2019-04-10

    Advanced Bionics Recalls Naída CI Q90 Sound Processor Due to Firmware Error

    Advanced Bionics is recalling one Naída CI Q90 Sound Processor because it was loaded with incorrect firmware. The device was distributed in North Carolina and several foreign countries.

    Product
    Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
    Category
    Medical Device
    Distribution
    1 state

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Advanced Bionics

Source: Wikidata (Q114268939), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.