Zhejiang Luyao Electronics Technology Co., Ltd. recalls Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number:…
Reason for recall
Regulatory documentation error and misleading color packaging claim.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 garmentUDIUDI 00031262108746
What the firm is doing
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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the country of Canada.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2463-2025
- FDA 510(k) clearance · K222949The device's official FDA premarket clearance record
- FDA device classification · IRPOfficial FDA classification for this device type
- CFR regulation · 21 CFR 890.5650The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Zhejiang Luyao Electronics Technology Co., Ltd.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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