Brand Name: HOMEDICS recallZ-2463-2025 · Zhejiang Luyao Electronics Technology Co., Ltd. · initiated Jan 17, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zhejiang Luyao Electronics Technology Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Regulatory documentation error and misleading color packaging claim.
FDA root cause category: Error in labeling
What the company 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.
Recall details
- Recall number
- Z-2463-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 17, 2025
- Posted by the FDA
- Aug 28, 2025
- Recalling firm
- Zhejiang Luyao Electronics Technology Co., Ltd.
- Quantity
- 3705 US
- Product code
- IRP
- FDA submissions
- K222949
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
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.
Code information (models, lots, serial numbers)
UDI: 00031262108746 Product Code: IRP Lot # : All lots affected, however they do not present risk of harm. Expiration Date: 2 YEARS
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HOMEDICS SR-160HJFka Distributing CO., LLC · Massager, Powered Inflatable Tube1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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