FDA WARNING_LETTER - ZIIP INC - January 12, 2026

ZIIP, Inc., located in Pleasant Hill, California, received an FDA Warning Letter following an inspection conducted from January 5 to January 12, 2026. The FDA identified significant quality system and marketing violations regarding the company"s ZIIP HALO and ZIIP DOT devices, as well as various conductive gels. The primary issues involve a failure to maintain adequate design controls and risk management. Specifically, the company ignored numerous consumer complaints reporting that devices were smoking, melting, or causing minor burns, failing to update their risk assessments or severity ratings accordingly. ZIIP also failed to properly validate its conductive gels for safety and efficacy. Additionally, the company implemented design changes, such as firmware updates and hardware modifications, without the required documentation, testing, or regulatory review. Beyond manufacturing concerns, the FDA determined that ZIIP is marketing several products without the necessary regulatory clearance. While the company holds clearances for basic facial stimulation, it is promoting the HALO 2.0 and DOT devices for medical purposes—such as boosting collagen, treating pigmentation, and improving circulation—that exceed their authorized cosmetic use. The conductive gels are also being sold as cosmetics despite functioning as regulated medical device components. Under the Federal Food, Drug, and Cosmetic Act, these products are considered adulterated and misbranded. ZIIP must immediately stop the unauthorized distribution of these devices and submit a written response within 15 business days. This response must detail the corrective actions taken to address systemic quality failures and provide a comprehensive plan to ensure future regulatory compliance.