BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1493-2026 · Initiated November 27, 2025

    Recall

    Recall Number
    Z-1493-2026
    Event Number
    98161
    Firm
    Advanced Bionics, LLC
    FEI Number
    1000220815
    Product Code
    MCM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 27, 2025
    Posted
    March 5, 2026
    Address
    28515 Westinghouse Pl, Valencia, CA, 91355-1398

    Description

    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.

    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.

    Distribution

    Unknown

    Quantity

    2 units