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

Timeline

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

Is HiResolution Bionic Ear System Sky CI M90 Sound Processor recalled?

Yes. Advanced Bionics recalled HiResolution Bionic Ear System Sky CI M90 Sound Processor on 27 Nov 2025. The recall is Class II and its status is Ongoing. Recall number Z-1493-2026.

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

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