FDA Medical devices recall ·
HOMEDICS Product Name: Air Compression Leg Massager Model recall
- Recall number
- Z-2463-2025
- Date
- (initiated January 17, 2025)
- Company / brand
- Zhejiang Luyao Electronics Technology Co., Ltd.
Pingyang County, Wenzhou, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3705 US
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Regulatory documentation error and misleading color packaging claim.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 00031262108746 Product Code: IRP Lot # : All lots affected, however they do not present risk of harm. Expiration Date: 2 YEARS
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2463-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.