ClearanceBrief
Recall Z-2463-2025 ยท IRP Massager, Powered Inflatable Tube

Zhejiang Luyao Electronics Technology Co., Ltd.

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

DateAug 28, 2025 (initiated Jan 17, 2025)
StatusOpen, Classified
ReasonRegulatory documentation error and misleading color packaging claim.
Root causeError in labeling
ActionOn 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.
Quantity3705 US
DistributionWorldwide distribution - US Nationwide and the country of Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K222949Air Compression Leg Massager (Model: LY-670D)
Zhejiang Luyao Electronics Technology Co., Ltd., Dec 22, 2022