Z-2463-2025Class II

Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product...

Name: Z-2463-2025 Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product...
Creator: Zhejiang Luyao Electronics Technology Co., Ltd.
Published: 2025-01-17
License: https://open.fda.gov/license/

Zhejiang Luyao Electronics Technology Co., Ltd. / initiated 2025-01-17 / Open, Classified / root cause: labeling and UDI

FDA source

Zhejiang Luyao Electronics Technology Co., Ltd. began a recall of Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on... on 2025-01-17. FDA classified it as Class II and gives the reason as "Regulatory documentation error and misleading color packaging claim". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2463-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-17
Posted: 2025-08-28
Recalling firm: Zhejiang Luyao Electronics Technology Co., Ltd.
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.
Product code: IRP Massager, Powered Inflatable Tube
Reason for recall: Regulatory documentation error and misleading color packaging claim.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 3705 US
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UDI: 00031262108746 Product Code: IRP Lot # : All lots affected, however they do not present risk of harm. Expiration Date: 2 YEARS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2463-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2463-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-28

Product code IRP

K222949Class IIAir Compression Leg Massager (Model: LY-670D)Zhejiang Luyao Electronics Technology Co., Ltd. / cleared 2022-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)