Data Foundry

Medical device recalls 2025

Brand Name: HOMEDICS Product Name: Air Compression Leg Massager… — Class II medical device recall Z-2463-2025

Ongoing recall by Zhejiang Luyao Electronics Technology Co., Ltd., reported 2025-09-03, distributed nationwide. Regulatory documentation error and misleading color packaging claim.

Recall numberZ-2463-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmZhejiang Luyao Electronics Technology Co., Ltd., Wenzhou, China
Recall initiated2025-01-17
Classified2025-08-28
Reported by FDA2025-09-03
DistributedNationwide (US)
Countries outside the USCA
Quantity3,705 us
UPC / GTIN / UDI-DI00031262108746
Model numbersSR-160HJ

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.

Reason for recall

Regulatory documentation error and misleading color packaging claim.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2463-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.