The Food and Drug Administration says 561 deaths have been reported in connection to recalled Philips devices to treat obstructive sleep apnea and other breathing disorders.

The FDA said that since April 2021 it has received more than 116,000 medical device reports of foam breaking down in Philips CPAP (continuous positive airway pressure) machines and BiPAP sleep therapy devices. That includes 561 reports of death, the agency said Wednesday.

The Dutch medical device maker has recalled millions of the breathing machines amid reports they were blowing gas and pieces of foam into the airways of those using the devices. 

The grim tally comes days after Philips said it would stop selling the machines in the U.S. in a settlement with the FDA and the Justice Department expected to cost roughly $400 million, the company disclosed in a regulatory filing. 

The tentative agreement, which must be approved by a U.S. court, calls for the company to keep servicing apnea machines already being used while stopping to sell new ones until specific conditions are met. 

After an initial recall announced in June of 2021, Philips attempted to fix some of the more than 5 million recalled devices, but the repaired ones were ultimately recalled as well.

Philips in late 2023 agreed to pay at least $479 million to compensate users of 20 different breathing devices and ventilators sold in the U.S. between 2008 and 2021. Claims for financial losses related to the purchase, lease or rent of the recalled machines can be now be lodged in the wake of a proposed class-action settlement reached in September.

Philips did not immediately respond to requests for comment.