Air Compression Leg Massager recalled for documentation error and misleading packaging claim
HOMEDICS Air Compression Leg Massager (Model SR-160HJ) is being recalled due to a regulatory documentation error and misleading color packaging claim. Approximately 3,705 units have been distributed in the United States and Canada.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall for labeling and documentation errors. The source explicitly states the affected product does not present a risk of harm. Per the rubric, minor labeling errors without reported injuries fall under Moderate.
Plain-English summary
HOMEDICS Air Compression Leg Massager, Model SR-160HJ, is a powered inflatable tube massager designed for temporary relief of minor muscle aches and pains and for temporary increase in circulation. Approximately 3,705 units have been distributed nationwide in the United States and in Canada.
The FDA has received notification that the product is subject to recall due to a regulatory documentation error and misleading color packaging claim. All lots of the product are affected by these issues.
According to the manufacturer, the affected product does not present a risk of harm to consumers. Consumers with questions about this recall can contact the product manufacturer or refer to the FDA's Medical Device database for additional information. The product is identified by Model Number SR-160HJ and Universal Device Identifier (UDI) 00031262108746.
The recalled product
- 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 f
- Manufacturer
- Zhejiang Luyao Electronics Technology Co., Ltd.
- Category
- Medical Device — Massage Device
- Hazard
- documentation-error
- misleading-packaging
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 00031262108746 Product Code: IRP Lot # : All lots affected
- however they do not present risk of harm. Expiration Date: 2 YEARS
Distribution
Distributed nationwide across the United States.
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