FDA Class II Recall: The product is a handheld ultraviolet-C germicidal wand… by Uvlizer c/o RAIS INTERNATIONAL LLC

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Uvlizer c/o RAIS INTERNATIONAL LLC and the affected product is described in FDA's record as: The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths at 274 nm and 397 nm.. FDA's stated reason for the recall is: 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 recall is tracked under FDA recall number Z-1808-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths at 274 nm and 397 nm. -- and the recall number Z-1808-2026. If it matches, stop using or distributing it and contact Uvlizer c/o RAIS INTERNATIONAL LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Uvlizer c/o RAIS INTERNATIONAL LLC’s FDA history

Argus HQ has recorded 2 total FDA actions tied to Uvlizer c/o RAIS INTERNATIONAL LLC: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths.

Has Uvlizer c/o RAIS INTERNATIONAL LLC had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 2 total FDA actions tied to Uvlizer c/o RAIS INTERNATIONAL LLC, including 2 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-1808-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

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