Advanced Bionics recalls

Advanced Bionics has 14 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 10 Jun 2026. 4 are still ongoing. 3 were reported in the last 12 months.

Total recalls14since 2012

Last 12 months3reported

Class I00% of total

Ongoing4latest 10 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 1 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 1 0Apr 1 1 0Jul 0 0

Severity split

Class I 0 0%Class II 10 71%Class III 4 29%

Why advanced bionics is recalled

Product types

By year

2026321%
202517%
2020643%
2019321%
201217%

Ongoing advanced bionics recalls

4 active

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Device	CLASS II	HiResolution" Bionic Ear System HiRes Ultra 3D CI HiFocus Mid Scala recalled	Advanced Bionics	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled	Advanced Bionics	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	HiResolution Bionic Ear System Sky CI M90 Sound Processor recalled	Advanced Bionics	Packaging Defects	CA
28 May 2025Device	CLASS II	HiResolution" Bionic Ear System - M Battery Charger recalled	Advanced Bionics	Packaging Defects	6 states

All advanced bionics recalls, newest first

14 total

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Device	CLASS II	HiResolution" Bionic Ear System HiRes Ultra 3D CI HiFocus Mid Scala recalled	Advanced Bionics	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled	Advanced Bionics	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	HiResolution Bionic Ear System Sky CI M90 Sound Processor recalled	Advanced Bionics	Packaging Defects	CA
28 May 2025Device	CLASS II	HiResolution" Bionic Ear System - M Battery Charger recalled	Advanced Bionics	Packaging Defects	6 states
2 Dec 2020Device	CLASS III	AB PowerCel 230 (velvet black) recalled by Advanced Bionics	Advanced Bionics	Labeling Errors	Nationwide
2 Dec 2020Device	CLASS III	AB PowerCel 170 (velvet black) recalled by Advanced Bionics	Advanced Bionics	Labeling Errors	Nationwide
27 May 2020Device	CLASS II	AB HiResolution Bionic Ear System, HiRes Ultra 3D CI recalled	Advanced Bionics	Potency & Assay	Nationwide
27 May 2020Device	CLASS II	AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode recalled	Advanced Bionics	Potency & Assay	Nationwide
11 Mar 2020Device	CLASS III	SoundWave Professional Suite recalled by Advanced Bionics	Advanced Bionics	Device Malfunction	Nationwide
26 Feb 2020Device	CLASS III	HiResolution Bionic Ear System HiRes 90K Advantage CI recalled	Advanced Bionics	Other	CA

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.