Recall Z-1493-2026— Advanced Bionics, LLC

Name: FDA recall Z-1493-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-27

Class II · Ongoing

Class II FDA medical device recall by Advanced Bionics, LLC, initiated 2025-11-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150. Reason: Behind-the-ear sound processer packaging label is different then included product..

Recalling firm: Advanced Bionics, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-11-27
Firm location: Valencia, CA, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.