Advanced Bionics, LLC is recalling its Sky CI M90 Sound Processor (Model/Catalog Number: CI-5295-150) under FDA Class II recall Z-1493-2026, initiated on March 11, 2026. The recall is due to a discrepancy where the packaging label for the behind-the-ear sound processor does not accurately reflect the product contained within. The distribution scope is currently listed as unknown.

This recall requires immediate attention from any entity that may have received or distributed these devices. While specific compliance deadlines or penalties are not detailed in this notice, companies must identify affected units, segregate them, and report any relevant information to Advanced Bionics and potentially the FDA. Failure to comply with recall procedures can result in regulatory action and potential harm to patients relying on these medical devices.