CLASS III Device recall · Reported 2 Dec 2020 · FDA Enforcement Report

AB PowerCel 230 (velvet black) recalled by Advanced Bionics

Advanced Bionics is recalling AB PowerCel 230 (velvet black), distributed nationwide in the US. The recall was initiated on 26 Sep 2020 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codes410079020

Quantity recalled53 units

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-0486-2021
FDA event ID: 86536
Recalling firm: Advanced Bionics, Valencia, CA
Classification: Class III
Status: Terminated
Recall initiated: 26 Sep 2020
FDA classified: 25 Nov 2020
Reported: 2 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Hearing Aids

Timeline

26 Sep 2020	Recall initiated by company
25 Nov 2020	Classified by FDA	+60 days
2 Dec 2020	Published in enforcement report	+7 days

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

Reason for recall

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy.

Nationwide Alabama California Florida Hawaii Illinois Louisiana Massachusetts Mississippi Nebraska New York Ohio South Carolina

Questions about this recall

Why was it recalled?

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

Which lots are affected?

410079020

Where was it sold?

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.

Other products in this recall event

1 other product · FDA event 86536

This product is part of a recall event; the main page for the event is AB PowerCel 170 (velvet black) recalled by Advanced Bionics.

Reported	Class	Recall	Company	Reason	Where
2 Dec 2020	CLASS III	AB PowerCel 170 (velvet black) recalled by Advanced Bionics	Advanced Bionics	Labeling Errors	Nationwide

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 170 (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