Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catal...
FDA Recall #Z-1493-2026 — Class II — November 27, 2025
Product Description
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Reason for Recall
Behind-the-ear sound processer packaging label is different then included product.
Recalling Firm
Advanced Bionics, LLC — Valencia, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2 units
Distribution
Unknown
Code Information
Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated