FDA WARNING_LETTER - GenderBender LLC - December 01, 2025

The FDA issued a Warning Letter to GenderBender LLC on December 16, 2025, following a review of the company"s website (genderbenderllc.com). The FDA determined that GenderBender LLC"s various breast binders, such as "Half Length Soft Binder with Zipper" and "Swimsafe Rigid Binder," are medical devices under the Federal Food, Drug, and Cosmetic Act. This classification is based on explicit claims on the website indicating their use for conditions like "gender euphoria," "gynecomastia," and post-surgical swelling reduction. The primary violations identified are the company"s failure to annually register as a medical device manufacturer and to list its devices with the FDA, as required by section 510 of the Act. As a result, the devices are considered misbranded under section 502(o) of the Act because they were manufactured in an unregistered establishment and were not listed. GenderBender LLC is required to take prompt corrective action to address these violations. The company must submit a written response to the FDA within fifteen business days, detailing the specific steps taken to correct the issues, including documentation, and outlining a plan to prevent future occurrences. Failure to comply may lead to further regulatory actions, such as device seizure or injunction.