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Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Recalled March 11, 2026 · FDA recall Z-1493-2026 · Advanced Bionics
Hazard
Behind-the-ear sound processer packaging label is different then included product. · FDA Class II
Units
2 units
Sold at
Unknown
Description
Behind-the-ear sound processer packaging label is different then included product.
Product
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Manufacturer(s)
Advanced Bionics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →