FDA WARNING_LETTER - LifeVac, LLC - April 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to LifeVac, LLC on September 18, 2025, addressing the unauthorized marketing of its LifeVac Rescue Suction Device. The FDA determined that this airway clearance device, intended for use during choking emergencies, is a Class III medical device. Under the Federal Food, Drug, and Cosmetic Act, Class III devices require either an approved premarket approval (PMA) application or an approved investigational device exemption (IDE) before being marketed. LifeVac, LLC lacks this essential marketing authorization, rendering the device adulterated. The FDA had previously informed LifeVac, LLC of the correct classification in April and May 2023, and explicitly instructed the company to cease marketing its unauthorized device on June 27, June 30, and August 4, 2025. Despite these communications and acknowledged receipt, LifeVac, LLC continued to market and distribute the device as of September 17, 2025. The FDA expressed concern that the continued unauthorized marketing poses potential public health and safety risks, citing a 2024 Safety Communication regarding unestablished safety and effectiveness of such devices and reports of problems including lack of suction and injuries. LifeVac, LLC is required to take prompt action to address these violations, including immediately ceasing all activities that result in the device"s adulteration. The company must notify the FDA in writing within fifteen business days, detailing specific corrective steps taken or planned, explaining how to prevent future violations, and providing supporting documentation. Failure to comply may lead to further regulatory actions such as seizure, injunction, or civil money penalties.