Medical device recalls Moderate risk

Zhejiang Luyao Electronics Technology Co., Ltd. recalls Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Pow…

Recall date
January 17, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2463-2025
FDA classification
Class II
Brand / firm
Zhejiang Luyao Electronics Technology Co., Ltd.
Sold / distributed
Worldwide distribution - US Nationwide and the country of Canada.

Why it was recalled

Regulatory documentation error and misleading color packaging claim.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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