The settlement comes nearly three years after the company acknowledged that an industrial foam fitted inside its machines could degrade and release toxic substances into the masks worn by patients.

Philips Respironics must hire an independent safety monitor, undergo regular facility inspections for five years and pay part of its revenue to the federal government under the terms of an agreement with prosecutors filed in federal court in Pennsylvania, capping one of the most catastrophic medical device recalls in decades.

The company will also face a review of its testing on the millions of replacement machines that it sent to customers after the old ones were recalled in 2021.