CLASS II ONGOING Device recall · Reported 11 Mar 2026 · FDA Enforcement Report

HiResolution Bionic Ear System Sky CI M90 Sound Processor recalled

Advanced Bionics is recalling HiResolution Bionic Ear System Sky CI M90 Sound Processor. The recall was initiated on 27 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603

Quantity recalled2 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-1493-2026
FDA event ID: 98161
Recalling firm: Advanced Bionics, Valencia, CA
Classification: Class II
Status: Ongoing
Recall initiated: 27 Nov 2025
FDA classified: 5 Mar 2026
Reported: 11 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

27 Nov 2025	Recall initiated by company
5 Mar 2026	Classified by FDA	+98 days
11 Mar 2026	Published in enforcement report	+6 days

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

Reason for recall

Behind-the-ear sound processer packaging label is different then included product.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

Where it was distributed

Unknown

Questions about this recall

Why was it recalled?

Behind-the-ear sound processer packaging label is different then included product.

Which lots are affected?

Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603

Where was it sold?

Unknown

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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
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

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30 Sep 2026Device	CLASS II	Medline Convenience Kits: Mfc Craniotomy Pack recalled	Medline Industries	Other	Nationwide