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The company responsible for a global recall of sleep apnea machines is now legally barred from resuming production at U.S. facilities until it meets a number of safety requirements. The agreement Tuesday with federal officials is a major step toward resolving a massive medical device recall that has dragged on for years. U.S. Justice Department officials said Dutch Manufacturer Philips will be legally required to overhaul its manufacturing and quality control systems and hire independent experts to vet the changes. Philips has recalled more than 5 million of the machines since 2021 because their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep.

United statesJeffrey reedEric olshanDepartment of justiceEducational media groupUs department of justiceDrug administrationScience departmentAssociated pressHoward hughes medical institute sciencePhilip pennsylvaniaAssociated press healthHoward hughes medical instituteEducational media