Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powe
FDA device recall Z-2463-2025 · posted 2025-08-28 · Open, Classified
Recall details
- Recalling firm
- Zhejiang Luyao Electronics Technology Co., Ltd.
- Reason for recall
- Regulatory documentation error and misleading color packaging claim.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- IRP
- Quantity affected
- 3705 US
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2025-01-17
- Date posted
- 2025-08-28
- Location
- Wenzhou Pingyang County, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Air Compression Leg Massager (Model: LY-670D) (K222949) | Zhejiang Luyao Electronics Technology Co., Ltd. | 2022-12-22 |