Class 2 Device Recall HiResolution Bionic Ear System

• Date Initiated by Firm: November 27, 2025
• Date Posted: March 05, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1493-2026
• Recall Event ID: 98161
• PMA Number: P960058S149
• Product Classification: Implant, cochlear - Product Code MCM
• Product: Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
• Code Information: Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
• FEI Number: 1000220815
• Recalling Firm/ Manufacturer: Advanced Bionics, LLC; 28515 Westinghouse Pl; Valencia CA 91355-1398
• For Additional Information Contact: Michelle Caulfield; 1-661-3621400
• Manufacturer Reason for Recall: Behind-the-ear sound processer packaging label is different then included product.
• FDA Determined Cause: Under Investigation by firm
• Action: On November 27, 2025, Advanced Bionics issued a recall notification to affected consignees via Email. Advanced Bionics ask consignees to take the following actions: Consignees to contact UK customer service to initiate the exchange of the mislabeled product with the correct product. Acknowledge receipt and understanding of the recall communication.
• Quantity in Commerce: 2 units
• Distribution: Unknown
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MCM