Class II U.S. Food and Drug Administration

Uvlizer c/o RAIS INTERNATIONAL LLC The product is a handheld ultraviolet-C germicidal recall: In some foreseeable use conditions, the Products can expose nearby persons

Recall published 6 months ago

In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.

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-1807-2026
Published
April 29, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Uvlizer c/o RAIS INTERNATIONAL LLC
Product type
Medical devices
Units affected
480,000
Made in
United States
Lot / code info
None provided.

Products covered by this recall

The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.

What to do about Device

Uvlizer c/o RAIS INTERNATIONAL LLC — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  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.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Uvlizer c/o RAIS INTERNATIONAL LLC — 16192 Coastal Hwy, Lewes, DE, 19958-3608

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 Uvlizer c/o RAIS INTERNATIONAL LLC medical devices recalled?

In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure. In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Device enforcement record, and contact the company if you are unsure.

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?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

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