Sleep Apnea Machine Maker Agrees To Halt Sales In U.S.

Philips has recalled its machines globally over risks their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep.

WASHINGTON (AP) — 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 machines due to risks that their internal foam can break down over time, leading users to inhale tiny particles and fumes 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 manufacturing giant 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.

Under the agreement’s terms, Philips would continue servicing previously sold machines in the U.S., but couldn’t sell new ones until it meets corrective actions laid out by the FDA. Company executives said they have set aside $393 million for operational changes and upgrades needed to comply.