Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: P
Summary
The FDA issued a Class II for Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog by Zhejiang Luyao Electronics Technology Co., Ltd.. Reason: Regulatory documentation error and misleading color packaging claim..
Details
Source
Device Recall
External ID
Z-2463-2025
Action Date
2025-09-03
Status
Ongoing
Category
device
Product 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.
Lot/Code Info: UDI: 00031262108746 Product Code: IRP Lot # : All lots affected, however they do not present risk of harm. Expiration Date: 2 YEARS
Quantity Affected: 3705 US
Reason for Recall
Regulatory documentation error and misleading color packaging claim.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-17
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zhejiang Luyao Electronics Technology Co., Ltd. has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zhejiang Luyao Electronics Technology Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zhejiang Luyao Electronics Technology Co., Ltd. have FDA actions?
Zhejiang Luyao Electronics Technology Co., Ltd. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2463-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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