LifeVac Lawsuit: FDA Warning Letter, FTC Probe, and Dechoker Mix-Up

No major private lawsuit against LifeVac LLC has surfaced in public records. The regulatory story is a different matter: a LifeVac lawsuit search almost always leads back to the company’s multi-year compliance fight with the U.S. Food and Drug Administration, which ended in a September 2025 warning letter and, six months later, the first FDA authorization ever granted to a suction anti-choking device. A separate Federal Trade Commission inquiry into the company’s “Made in the USA” advertising closed in January 2025 without a legal finding of violation.

The September 2025 FDA Warning Letter

On September 18, 2025, the FDA issued a formal warning letter to Arthur Lih, LifeVac’s founder and CEO, for marketing and distributing the “LifeVac Rescue Suction Device” without required FDA authorization.¹ The agency classified the device as Class III, its highest-risk category, which meant premarket approval was required before the product could legally be sold in the United States. Because LifeVac lacked that approval, the FDA deemed the product adulterated under federal law.

The letter demanded that LifeVac stop marketing and distributing the device immediately and submit a written response within 15 business days describing its corrective actions. The FDA warned that continued noncompliance could lead to seizure of the products, a court injunction, and civil money penalties, and noted that other federal agencies could weigh the violation when awarding government contracts.¹

A Two-Year Run-Up to Enforcement

The warning letter was not the FDA’s first attempt to bring LifeVac into compliance. The company had registered the device as Class II when it launched commercially in 2014, a classification with lighter regulatory requirements.² The FDA disagreed. Its contacts with the company stretched over more than two years:

In April and May 2023, the FDA first notified LifeVac that the device was actually Class III and discussed the need for a premarket submission.¹
On April 22, 2024, the FDA issued a public safety communication about unauthorized over-the-counter anti-choking devices, citing reports of device failures, facial bruising, and throat injuries.³
On June 27 and June 30, 2025, the FDA formally requested that LifeVac cease marketing and distribution until it obtained authorization.
On August 4, 2025, the FDA reiterated that the device lacked authorization and that continued sales were unlawful.

Despite acknowledging these communications, LifeVac kept selling the device. As of September 17, 2025, the day before the warning letter issued, the company was still marketing and distributing it. Even after the letter, the device remained available on the LifeVac website in mid-October 2025, according to the Regulatory Affairs Professionals Society.²

How the FDA Case Resolved

The regulatory standoff ended on March 4, 2026, when the FDA granted LifeVac a De Novo classification, making it the first and only anti-choking suction device authorized for marketing in the United States.⁴ The De Novo pathway is used when no substantially equivalent device already exists on the market, so a traditional 510(k) comparison is not possible. Through this process the FDA reclassified suction anti-choking devices as Class II rather than Class III, subject to both general and special controls.⁵

The authorization came with strict conditions. The FDA defined the device as a “second-line treatment,” meaning it is only to be used after standard choking rescue techniques like back blows and abdominal thrusts have failed. It is authorized for use on choking victims at least one year old, by lay people or medical professionals aged 18 and older, in settings including homes, nursing homes, restaurants, and schools.⁶

The special controls include mandatory postmarket surveillance. LifeVac must track real-world outcomes such as the rate of successful choking resolution, adverse events, and whether device use causes delays in starting basic life support. The company was required to submit a study protocol by April 3, 2026, and must reach full subject enrollment within 60 months. Progress reports are due every six months, with more frequent reporting if enrollment milestones are missed.⁵ Failure to comply could result in the device being deemed adulterated and misbranded again.

The same day it granted authorization, the FDA issued a close-out letter for the September 2025 warning, stating that it had evaluated LifeVac’s corrective actions and determined the violations had been addressed.⁷ Lih said in a statement that the classification “creates a clear regulatory framework for suction anti-choking devices used as a second-line treatment.”⁸

The FTC “Made in the USA” Investigation

Separately from the FDA dispute, LifeVac faced a Federal Trade Commission investigation into its advertising. The FTC examined marketing materials in which LifeVac promoted its products as “Made in the USA” when they contained significant imported content, a potential violation of the FTC’s Made in USA Labeling Rule. Under that rule, an unqualified “Made in the USA” claim implies that final assembly, all significant processing, and virtually all components are domestic.⁹

The investigation covered television and social media campaigns. LifeVac removed all “Made in the USA” claims from its marketing materials in response. The FTC issued a closing letter on January 21, 2025, addressed to Lih and company president Michael Plunkett. The agency noted that closure was not a legal determination that no violation had occurred and reserved the right to reopen the matter. Under federal law, each violation of the labeling rule can carry a civil penalty of up to $53,088.⁹

During the investigation, LifeVac also told the FTC that unauthorized websites were selling counterfeit LifeVac devices with their own unqualified “Made in USA” claims. The company said it was maintaining records of these sellers and working to shut them down.⁹

Adverse Event Reports Filed With the FDA

The FDA’s MAUDE database, which tracks medical device adverse events, contains a small number of reports involving the LifeVac. One report from October 2024 involved the death of an 11-year-old student at an elementary school. LifeVac filed the report “out of an abundance of caution” after media reports claimed the device had been used during the incident, but the company stated it was never contacted by the school, emergency services, or the family and could not confirm that the child had choked or that the device was actually used.¹⁰

A June 2022 report described an incident in which a 9-year-old was choking on a lollipop and the LifeVac device allegedly caused the candy to shatter into pieces, which the reporter said could pose a risk of further airway complications. LifeVac responded that the report omitted the fact that the device successfully dislodged the obstruction and the child was able to breathe. The FDA categorized the event as a malfunction with no apparent adverse outcome.¹¹¹² MAUDE reports document allegations submitted to the agency; they are not lawsuits and do not establish that a device caused the outcome reported.

Don’t Confuse LifeVac With Dechoker

A more aggressive federal enforcement action has hit a different anti-choking device, and it is easy to mix the two up. Dechoker LLC received its own FDA warning letter in May 2021 for quality system regulation violations.³ According to Forbes, the FDA later obtained a seizure warrant for the funds of Dechoker’s founders, Alan Carver and his wife, after alleging that the couple continued selling the device on Amazon after being directed to stop in 2023. The unsealed warrant showed $8.2 million in Amazon sales between 2023 and May 2025. Prosecutors also alleged that Carver forged employee signatures to close out consumer complaints about device failures and injuries. Amazon removed the Dechoker from its platform. As of October 2025, no criminal charges had been filed.¹³ That case involves Dechoker, not LifeVac.

1
U.S. Food and Drug Administration. LifeVac LLC Warning Letter 713455
2
Regulatory Affairs Professionals Society. FDA Warns LifeVac for Marketing Unauthorized Anti-Choking Device
3
U.S. Food and Drug Administration. Update: FDA Encourages Public to Follow Established Choking Rescue Protocols
4
U.S. Food and Drug Administration. De Novo Classification Request DEN250012
5
U.S. Food and Drug Administration. De Novo Classification Order DEN250012
6
PR Newswire. LifeVac Becomes the First and Only FDA-Authorized Anti-Choking Device
7
U.S. Food and Drug Administration. LifeVac LLC Close-Out Letter 713455
8
Fierce Biotech. FDA Greenlights Backup Anti-Choking Suction Device
9
Federal Trade Commission. Closing Letter to Life Vac LLC
10
U.S. Food and Drug Administration. MAUDE Adverse Event Report 21648847
11
U.S. Food and Drug Administration. MAUDE Adverse Event Report 16409910
12
U.S. Food and Drug Administration. MAUDE Adverse Event Report 15043658
13
Forbes. Couple Made Millions on Amazon Selling Banned Dechoker Medical Device, FDA Says