Advanced Bionics, LLC recalls
Every recall we track for Advanced Bionics, LLC — 13 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Advanced Bionics, LLC peaked in 2019 (5); 13 since 2017.
All FDA recall records for Advanced Bionics, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 4 | 1 | 5 |
| 2020 | 0 | 0 | 4 | 0 | 4 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 2 | 0 | 2 |
| 2026 (to date) | 0 | 1 | 1 | 0 | 2 |
Most common reasons for Advanced Bionics, LLC recalls
What to do if you have a recalled Advanced Bionics, LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Advanced Bionics, LLC recalls
9 shown- Lower riskMedical device
Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number:
HiResolution recalls HiRes Ultra 3D CI HiFocus Mid Scala cochlear implants due to incorrect shelf-life expiration dates. Affected units may expire prematurely, leading to potential product failure.
HiResolutionApr 30, 2026 - Use cautionMedical device
Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110;
HiResolution recalls M Zn-Air Battery Paks (models CI-5501-110 to CI-5501-280) due to non-tamperproof battery door that may not require tool to replace battery, risking improper installation.
HiResolutionMar 23, 2026 - Lower riskMedical device
Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
HiResolution recalls Sky CI M90 Sound Processors with mismatched packaging labels. Affected units may have incorrect labeling; contact for remedy.
HiResolutionNov 27, 2025 - Lower riskMedical device
Advanced Bionics, LLC recalls HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Advanced Bionics recalls HiResolution Bionic Ear System M Battery Charger Model CI-5607 due to incorrect labeling matching the intended product. Affected units include specific lot numbers.
Advanced BionicsMar 5, 2025 - Lower riskMedical device
Advanced Bionics, LLC recalls AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da
Advanced Bionics recalls some AB PowerCel 170 (velvet black) batteries for potential mislabeling that could lead to incorrect battery life claims. Affected units were sold with specific cochlear implant devices.
Advanced BionicsSep 26, 2020 - Lower riskMedical device
Advanced Bionics, LLC recalls AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a
Advanced Bionics recalls HiResolution Bionic Ear Systems (model CI 1600 04/05) due to hearing performance issues from body fluids entering the device. Affected units sold with lot numbers 1000000-1999999.
Advanced Bion: Bionic Ear SystemFeb 17, 2020 - Lower riskMedical device
Advanced Bionics, LLC recalls SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical
Advanced Bionics recalls SoundWave Professional Suite Software 3.2 due to installation errors when using the USB drive. Users can continue programming devices with current software versions.
Advanced BionicsApr 4, 2019 - UnratedMedical device
Advanced Bionics, LLC recalls HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Advanced Bionics recalls HiRes 90K Advantage CI HiFocus MS Electrode cochlear implants due to missing bio-compatible materials in Japan's PMDA submission. Not distributed in the US.
Advanced BionicsMar 18, 2019 - Lower riskMedical device
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
Advanced Bionics recalls Q70 Sound Processors with Sand Beige, Silver Gray, and Velvet Black models due to incorrect firmware loading. Affected units may not function properly.
Advanced BionicsFeb 6, 2019
Advanced Bionics, LLC recall questions
How many recalls has Advanced Bionics, LLC had?
13 recalls from Advanced Bionics, LLC are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Advanced Bionics, LLC recall?
Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number:, dated Apr 30, 2026. Every Advanced Bionics, LLC recall is listed on this page, newest first.
Why are Advanced Bionics, LLC products recalled?
The most common reasons on record: The sound processors were loaded with the incorrect firmware. (3); hearing performance degradation due to body-fluid entering the device. (2).
What should I do if I have a recalled Advanced Bionics, LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Advanced Bionics, LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.