FDA WARNING_LETTER - Trans-Missie B.V. - December 01, 2025

The FDA issued a Warning Letter to Trans-Missie B.V. (d/b/a UNTAG) on December 16, 2025, following a review of their website. The FDA determined that the company"s breast binders, sold under various trade names, are considered medical devices. This classification is based on claims made on their website, such as helping reduce gender dysphoria, affecting body structure, and assisting individuals who have had breast surgery. Under the Federal Food, Drug, and Cosmetic Act, manufacturers of medical devices are required to annually register their establishment with the FDA and list their devices electronically. Trans-Missie B.V. failed to meet these requirements for fiscal year 2026, leading to the devices being deemed "misbranded." The FDA mandates that Trans-Missie B.V. take immediate action to correct these violations. The company must submit a written response to the FDA within fifteen business days, outlining the specific steps taken to address the issues, including documentation of corrections and a plan to prevent similar violations in the future. Failure to comply may result in further regulatory actions, such as device seizure or injunction.