Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Summary
The FDA issued a Class II for Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Proce by Advanced Bionics, LLC. Reason: Behind-the-ear sound processer packaging label is different then included product..
Details
Source
Device Recall
External ID
Z-1493-2026
Action Date
2026-03-11
Status
Ongoing
Category
device
Product Description
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Lot/Code Info: Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
Quantity Affected: 2 units
Reason for Recall
Behind-the-ear sound processer packaging label is different then included product.
Distribution
Unknown
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-27
Company
Valencia, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 133 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Advanced Bionics, LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Advanced Bionics, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Advanced Bionics, LLC have FDA actions?
Advanced Bionics, LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1493-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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