Hearing Aids recalls

22 medical device recalls in the hearing aids category are on file with the FDA, from 2012 to 24 Jun 2026. The leading reason is device malfunction.

Total recalls22since 2012

Last 12 months5reported

Class I00% of total

Ongoing7latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 1 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 2Feb 0 0 2May 1 0 0Aug 0 0

Severity split

Class I 0 0%Class II 18 82%Class III 4 18%

Why hearing aids is recalled

Companies

By year

2026523%
202429%
2020523%
2019523%
201815%
201515%
201429%
201215%

Ongoing hearing aids recalls

7 active

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Medline convenience kits: Discectomy Pack DYNJ86476B Ear recalled	Medline Industries	Device Malfunction	Nationwide
13 May 2026Device	CLASS II	See RES for full list recalled by Medline Industries	Medline Industries	Sterility	Nationwide
6 May 2026Device	CLASS II	HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled	Advanced Bionics	Device Malfunction	Nationwide
25 Feb 2026Device	CLASS II	Medline Convenience Kits: Chp Cochlear Supplement Cds recalled	Medline Industries	Sterility	Nationwide
4 Feb 2026Device	CLASS II	Medline medical procedure convenience kits labeled as recalled	Medline Industries	Device Malfunction	Nationwide
11 Dec 2024Device	CLASS II	Medline convenience kits labeled as: Zale Head & Neck Cds recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide

All hearing aids recalls, newest first

22 total

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Medline convenience kits: Discectomy Pack DYNJ86476B Ear recalled	Medline Industries	Device Malfunction	Nationwide
13 May 2026Device	CLASS II	See RES for full list recalled by Medline Industries	Medline Industries	Sterility	Nationwide
6 May 2026Device	CLASS II	HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled	Advanced Bionics	Device Malfunction	Nationwide
25 Feb 2026Device	CLASS II	Medline Convenience Kits: Chp Cochlear Supplement Cds recalled	Medline Industries	Sterility	Nationwide
4 Feb 2026Device	CLASS II	Medline medical procedure convenience kits labeled as recalled	Medline Industries	Device Malfunction	Nationwide
11 Dec 2024Device	CLASS II	Medline convenience kits labeled as: Zale Head & Neck Cds recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
24 Jul 2024Device	CLASS II	Mi1250 Synchrony recalled by MED-EL Elektromedizinische	Med-el Elektromedizinische Gereate	Device Malfunction	NC
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
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
15 Jan 2020Device	CLASS II	Cochlear Baha 5 Sound Processor Tamper Proof Battery Door recalled	Cochlear Americas	Packaging Defects	10 states
4 Dec 2019Device	CLASS II	Behind-the-Ear hearing aids recalled by GN Hearing A/S	GN Hearing	Device Malfunction	Nationwide
4 Dec 2019Device	CLASS II	In-the-Ear hearing aids recalled by GN Hearing A/S	GN Hearing	Device Malfunction	Nationwide
14 Aug 2019Device	CLASS II	MED EL Cochlear Implant System, PULSARci100 Standard recalled	Med-el Elektromedizinische Gereate	Packaging Defects	Nationwide
14 Aug 2019Device	CLASS II	MED EL Cochlear Implant System, SONATATIi100 recalled	Med-el Elektromedizinische Gereate	Packaging Defects	Nationwide
14 Aug 2019Device	CLASS II	MED EL Cochlear Implant System, Mi1000 MED EL Concerto recalled	Med-el Elektromedizinische Gereate	Packaging Defects	Nationwide
17 Oct 2018Device	CLASS II	BABY hearing aid (referred to as BABY440) recalled by Widex A/S	Widex	Device Malfunction	GA, NY
29 Jul 2015Device	CLASS II	Cochlear Nucleus Sterile Silicone Template recalled by Cochlear Americas	Cochlear Americas	Sterility	Nationwide
11 Jun 2014Device	CLASS II	Cochlear Baha Soft tissue gauge Reusable instrument used recalled	Cochlear Americas	Foreign Material	Nationwide
26 Feb 2014Device	CLASS II	Siemens Prisma 2K Hearing Aid recalled by Siemens Hearing Instruments	Siemens Hearing Instruments	Device Malfunction	Nationwide
1 Aug 2012Device	CLASS II	Oto Ease by Westone, labeled as a bacteria free recalled	Westone Laboratories	Sterility	Nationwide

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.