The company behind a global recall of sleep apnea machines said Monday it will stop selling the devices in the U.S., under a tentative agreement with regulators that could cost the manufacturer nearly $400 million.

Device maker Philips has recalled more than 5 million pressurized breathing devices due to risks that their internal foam can break down over time, leading users to inhale tiny particles while they sleep.

The company first announced the problem in mid-2021, but efforts to repair or replace the machines have dragged on for years, frustrating patients in the U.S. and other countries.

The Dutch company said it has agreed to a consent decree with the Food and Drug Administration and the Department of Justice. The deal has not yet been finalized and will have to be approved by a U.S. judge. Philips executives disclosed the tentative agreement during a quarterly earnings update.

$393 million set aside

Under terms of the agreement, Philips would continue servicing recalled machines in the U.S., but would not be able to sell new ones until meeting several corrective actions laid out by the FDA. Company executives said they have set aside $393 million to deal with expenses needed to comply.

The company promised it would put “safety and quality at the center of everything we do with a greater level of accountability,” Philips CEO Roy Jakobs told analysts and investors.

The FDA’s website warns patients that the risks of ingesting the sound-dampening foam could include headache, asthma, allergic reactions and more serious problems. In November, the agency issued a new warning that the machines can overheat, in rare cases causing fires.

The agency said it cannot comment on Philips’ announcement until a final agreement is “signed and filed with the court.”

Customer delays

In 2022, the FDA took the rare step of ordering Philips to step up its outreach to customers about the recall including “clearer information about the health risks of its products.” At the time, the agency estimated only about half the people in the U.S. with affected machines knew they had been recalled.

Customers trying to obtain refunds or new or refurbished devices from the company have reported months of delays.

The devices are called continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep passageways open during sleep.

Untreated sleep apnea can cause people to stop breathing hundreds of times per night, leading to dangerous drowsiness and increased heart attack risk. The problem is more common in men than women, with estimates ranging from 10% to 30% of adults affected.

The latest announcement does not resolve 675 personal injury lawsuits filed against the company over the devices. Those suits have been consolidated in a federal court in Pennsylvania.

Philips faces similar legal action in Canada, Australia, Israel and Chile, according to the company’s update.