Advanced Bionics, LLC Recalls
2 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (2)
- Class II
November 27, 2025
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Behind-the-ear sound processer packaging label is different then included product.
- Class II
March 5, 2025
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
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.