BEUDAMED
    FDA Recall Open, Classified

    Recreo Hair Growth Laser Comb

    Recall: Z-1222-2023 · Initiated September 1, 2022

    Recall

    Recall Number
    Z-1222-2023
    Event Number
    91839
    Firm
    OMM Imports, Inc. dba Zero Gravity
    FEI Number
    3012327767
    Product Code
    OAP
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    September 1, 2022
    Posted
    March 14, 2023
    Address
    940 Lincoln Rd, Ste 307, Miami Beach, FL, 33139-2619

    Description

    Recreo Hair Growth Laser Comb

    Reason

    The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information, reproductions and locations of the labels, and a warning statement in the user manual.

    Action

    Letters were sent to all retailers/distributors and any direct purchasers advising of the affected device nonconformance. The letter informed customers that an updated user manual and the appropriate labels will be provided to correct the error, without charge.

    Distribution

    Worldwide and Nationwide including DC and Puerto Rico

    Quantity

    1620 units shipped to United States