Skytron, LLC – FDA Warning Letter, May 11, 2026

Skytron, LLC, based in Grand Rapids, Michigan, was issued an FDA Warning Letter on May 19, 2026, following a regulatory review of its digital marketing materials on May 11, 2026. The agency determined that the company is marketing several UVC disinfection systems—the 1140 Sentry, 2280 Syndicate, 3200 Max, and UV Smart D25—as medical devices without obtaining the necessary FDA clearance or approval. Under the Federal Food, Drug, and Cosmetic Act, these products are classified as medical devices because they are intended to prevent disease and disinfect healthcare environments. The primary violations include distributing unapproved and misbranded products into interstate commerce. Specifically, the FDA noted that Skytron failed to submit premarket notifications and incorrectly claimed that the UV Smart D25 was exempt from such requirements. Furthermore, the company made misleading statements suggesting that its registration with the agency implied official endorsement or evaluation. The FDA expressed concern that Skytron provided no clinical evidence to support the safety or effectiveness of these devices, posing risks of patient cross-contamination or physical harm from UV exposure. Despite previous warnings from the FDA dating back to 2022, the company failed to remove healthcare-related claims from its promotional materials. Skytron is required to immediately stop the illegal marketing of these devices and must provide a written response within 15 business days. This response must outline a comprehensive plan to correct the violations and prevent future occurrences. Failure to comply may lead to further regulatory action, including product seizures, legal injunctions, or financial penalties.