The U.S. Food and Drug Administration (FDA) recently warned consumers that certain brands of ultraviolet (UV) wands could pose a potential risk of injury upon use. These wands are used to disinfect surfaces and eliminate germs in settings outside of most health care settings, such as in residential properties. FDA says that the affected products may emit unsafe levels of ultraviolet-C (UV-C) radiation that could cause harm to the user or any nearby person.  

Anyone exposed to unsafe levels of UV-C could suffer injury to the skin and/or eyes a few seconds after using the product.  

Dangerous Radiation Levels  

FDA’s Center for Devices and Radiological Health (CDRH) tested certain handheld UV wands and found that they are defective under 21 CFR 1003.2(b)(2), which states: “Without regard to the design specifications of the product, emits electronic product radiation unnecessary to the accomplishment of its primary purpose which creates a risk of injury, including genetic injury to any person.”  

FDA listed the following products in their warning to consumers:  

• Safe T Lite from Max-lux Corporation 
• OttLite Rechargeable UVC Disinfecting wand, model UV10002M, from OttLite Technologies 
• UVILIZER FLIP, model SG-153 from In My Bathroom LLC. 
• Portable UV Light Wand Sterilizer, also from In My Bathroom 
• Ultraviolet Sterilamp PURPLEGLOW from Vanelc 
• Sharper Image UV Sanitizing Portable Wand, model 101362 from MerchSource LLC 
• SurfaceSoap UV from PhoneSoap LLC 
• Magic UV Light Sanitizer from Magic UV Light Sanitizer 

In some cases, the products also contained features that cause additional risk. These features include lack of safety information or protection for users and claims that the products disinfect in seconds, indicating the likelihood that the product is emitting an unsafe level of UV-C radiation.  

The International Commission on Non-Ionizing Radiation Protection (ICNIRP) recommends limits for UV-C radiation emission. Some of the wands FDA tested gave off up to 3,000 times more UV-C radiation than the level recommended by ICNIRP. Those exposed to excessive radiation from using or being in proximity to the product in use could experience erythema, a burn-like skin reaction or photokeratitis, an eye injury causing severe pain and the sensation of sand in the eyes.  

FDA’s Response 

On July 20, 2022, FDA issued a warning to consumers not to use the affected products. Prior to the warning, FDA issued Notification of Defect Letters to manufacturers that were distributing products found to be unsafe through FDA’s testing. Companies that received notification were given 15 days to respond to FDA with either: (1) A refutation, (2) An exemption request, or (3) A Corrective Action Plan (CAP) indicating how they will address the cited issues, as well as a copy of a written Notification Letter sent to purchasers and dealers. In the letters, FDA notified companies that, if they did not take action to address issues after 15 days, they may be required to proceed with sending notification to affected persons in accordance with 21 CFR 1003.11(c).