Class IIReported 2026-03-11

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

Recalled by Advanced Bionics, LLC

Reason for Recall

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

Recall Number

Z-1493-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-11-27

Reported

2026-03-11

Distribution

Unknown

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.