FDA warns LifeVac for marketing unauthorized anti-choking device
The US Food and Drug Administration (FDA) has sent a warning letter to LifeVac LLC for marketing its LifeVac rescue suction device without obtaining premarket approval. FDA said it considers the product to be a Class III device subject to premarket approval requirements.The LifeVac device has been marketed in the US since 2014 and is currently FDA-registered as a Class II device. In a warning letter to LifeVac CEO Arthur Lih, dated 18 September, FDA noted that it contacted the company in April and May 2023, and several times in 2025, to inform it that the device is incorrectly classified and that it must be authorized before it can be marketed. The device remains available for purchase from LifeVac’s website at the time of this article’s publication.
In the letter, FDA expressed concern that the company’s ongoing unauthorized marketing and distribution of the LifeVac Rescue Suction Device could jeopardize public health and safety. The device is intended to resuscitate a victim with an airway obstruction and includes a mask connected to a suction device; the mask fits over the face, and the plunger creates upward pressure to suck up the obstruction.
The agency stated that the device is also considered adulterated because the company does not have an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE).
After writing to the company in 2023, FDA wrote to it again on 27 June and 30 June 2025, reiterating its expectation that the company stop marketing and distributing the device until it received the necessary authorization. The FDA repeated this request on 4 August 2025.
The warning letter refers to an April 2024 safety communication in which the agency claims that the safety and effectiveness of unauthorized anti-choking devices being sold over the counter have not been established. It noted several issues associated with these devices, including failure to effectively resolve choking incidents due to inadequate suction, bruising around the face, lips, and mouth, and scratches in the back of the throat.
FDA stated that rescue protocols for choking include abdominal thrusts, commonly known as the Heimlich maneuver, but do not include anti-choking devices.
FDA stated that the firm acknowledged the communications but continued to market and distribute the product. The agency gave the company 15 days to respond to the warning letter.
FDA’s Manufacturer and User Facility Device Experience (MAUDE) database contains three reports related to the LifeVac device; one that pertains to an 11-year-old student who reportedly died after choking. According to that report, multiple attempts at clearing the obstruction, including the Heimlich maneuver and via the LifeVac device, were unsuccessful. LifeVac, which submitted the report to FDA after learning of a news report of the incident, stated that “there was no clear indication the child choked or that the lifevac [sic] use was appropriate or that it was ineffective.”
Two other reports cite a testimonial from LifeVac’s website that describe the reported use of the device to clear an obstruction from a 9-year-old boy who choked on a lollipop. LifeVac’s website reportedly stated that the device shattered the lollipop and dislodged it. The two MAUDE reports state that the shattered lollipop could have caused injury to the child.
The company’s website claims that LifeVac has successfully saved multiple lives, and a recent video report from Inside Edition cites multiple instances of the device being used to clear an obstruction from infants.
Warning letter
