BEUDAMED
    FDA Enforcement Class III Ongoing

    AcoSound. Model Number: LW12-BTE-M

    Recall: Z-1976-2025 · Reported June 25, 2025

    Enforcement

    Recall Number
    Z-1976-2025
    Event ID
    96904
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 25, 2025
    Initiation Date
    April 25, 2025
    Classification Date
    June 13, 2025
    Address
    No.2 Building Room 401, No. 1390 Cangxing Street, Yuhang, Hangzhou, N/A, N/A, China

    Description

    AcoSound. Model Number: LW12-BTE-M

    Reason

    Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manufactured by Hangzhou AcoSound." And the labeling has no statement of the place of business for the manufacturer. 2. Customer information: The customer "Blaid" information is not correctly marked; Blaid is not the manufacturer. 3. UDI Information: The UDI information is incomplete and without DI information and correct Pl information, not complied with UDI label requirements.

    Code Info

    UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802

    Distribution

    US Nationwide distribution in the state of New York.

    Quantity

    120 units