FDA Recall Open, Classified

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 · Initiated January 17, 2025

Recall

Recall Number
Z-2463-2025
Event Number
97333
Firm
Zhejiang Luyao Electronics Technology Co., Ltd. Pingyang County Wenzhou China
FEI Number
3009942828
Product Code
IRP
Status
Open, Classified
Root Cause
Error in labeling
Initiated
January 17, 2025
Posted
August 28, 2025

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.

Action

On January 17, 2025, Luyao notified their US distributor about the product recall. The company has declared permanent cessation of production and sales for the affected massager. Firm is collecting unsold inventory from warehouses.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Quantity

3705 US