Class II U.S. Food and Drug Administration

Zhejiang Luyao Electronics Technology Co., Ltd. Brand Name: Homedics Product Name recall: Regulatory documentation error and misleading color packaging claim

Recall published 1+ years ago

Regulatory documentation error and misleading color packaging claim.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Regulatory documentation error and misleading color packaging claim.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2463-2025
Published
September 3, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Zhejiang Luyao Electronics Technology Co., Ltd.
Product type
Medical devices
Units affected
3705 US
Distribution
Nationwide
Made in
China
Lot / code info
UDI: 00031262108746 Product Code: IRP Lot # : All lots affected, however they do not present risk of harm. Expiration Date: 2 YEARS
UPC codes
00031262108746

Products covered by this recall

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.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00031262108746

Model or item number

On the rating label, the box or the instruction sheet.

  • IRP Lot

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Zhejiang Luyao Electronics Technology Co., Ltd. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Zhejiang Luyao Electronics Technology Co., Ltd. — Pingyang County, Wenzhou

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Zhejiang Luyao Electronics Technology Co., Ltd. medical… recalled?

Regulatory documentation error and misleading color packaging claim. Regulatory documentation error and misleading color packaging claim.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00031262108746; model number IRP Lot. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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