Z-2463-2025 Class II Ongoing
FDA device recall Z-2463-2025 was initiated by Zhejiang Luyao Electronics Technology Co., Ltd. on January 17, 2025 and is designated Class II. Reason for recall: Regulatory documentation error and misleading color packaging claim. The recall status is ongoing. Affected quantity: 3705 US.
Recall Details
- Product Type
- Devices
- Report Date
- September 3, 2025
- Initiation Date
- January 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3705 US
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.
Reason for Recall
Regulatory documentation error and misleading color packaging claim.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
UDI: 00031262108746 Product Code: IRP Lot # : All lots affected, however they do not present risk of harm. Expiration Date: 2 YEARS