medical Class II Updated 2026-03-11

Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sk

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Unknown
Lot/Code Info: Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
View official government recall

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