CLASS III Device recall · Reported 26 Feb 2020 · FDA Enforcement Report

HiResolution Bionic Ear System HiRes 90K Advantage CI recalled

Advanced Bionics is recalling HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode. The recall was initiated on 18 Mar 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesAll Lots, UDI (01)07630016832185 Not distributed within the US

Quantity recalled4

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1259-2020
FDA event ID: 84617
Recalling firm: Advanced Bionics, Valencia, CA
Classification: Class III
Status: Terminated
Recall initiated: 18 Mar 2019
FDA classified: 18 Feb 2020
Reported: 26 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hearing Aids

Timeline

18 Mar 2019	Recall initiated by company
18 Feb 2020	Classified by FDA	+337 days
26 Feb 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.

Where it was distributed

No US distribution OUS: Japan

Questions about this recall

Why was it recalled?

Which lots are affected?

All Lots, UDI (01)07630016832185 Not distributed within the US

Where was it sold?

No US distribution OUS: Japan

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Advanced Bionics

All 14

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

Other Hearing Aids recalls

All 22

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