BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on the leg. The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

    Recall: Z-2463-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2463-2025
    Event ID
    97333
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zhejiang Luyao Electronics Technology Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 3, 2025
    Initiation Date
    January 17, 2025
    Classification Date
    August 28, 2025
    Address
    Pingyang County, Wenzhou, N/A, China

    Description

    Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on the leg. The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

    Reason

    Regulatory documentation error and misleading color packaging claim.

    Code Info

    UDI: 00031262108746 Product Code: IRP Lot # : All lots affected, however they do not present risk of harm. Expiration Date: 2 YEARS

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    3705 US