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

CBS News reports 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.

READ MORE: CPAP settlement: $479 million set aside after recall of breathing machines

According to CBS, Philips first announced the problem in mid-2021, but efforts to repair or replace the machines have dragged on for years.

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.