Class II
Medical Device Recall: Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Advanced Bionics, LLC · November 27, 2025
Reason for Recall
Behind-the-ear sound processer packaging label is different then included product.
Distribution
Unknown
Quantity Affected
2 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1493-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.