FDA recall Z-2463-2025

Zhejiang Luyao Electronics Technology Co., Ltd. · Class II · device

Product

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 for recall

Regulatory documentation error and misleading color packaging claim.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2025-01-17
Report date
2025-09-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wenzhou, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2463-2025