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MEMPHIS, Tenn. — A major medical equipment maker has issued a recall potentially affecting millions of people. 

Philips is voluntarily recalling certain Bi-Level PAP, CPAP, and mechanical ventilator devices. See recall alert here.

Those are used to help people breathe while sleeping. Some ventilators are also on that list.

The company says the problem lies within the foam component of the devices, which is used to cut down on the sound the machine makes. 

The company says the foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled. That foam could release certain chemicals. 

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According to, an estimated 22 million Americans suffer from sleep apnea. Left untreated it can lead to major health consequences.

CPAP machines increase air pressure in the throat so the airway doesn’t collapse while breathing.

Philips says the majority of the affected devices within the advised five-year service life are in the first-generation DreamStation product family.

“It could affect a lot of people.” said Robert Williams, owner of Direct Medical Supplies. He doesn’t sell CPAP machines but sells the equipment needed to use the machines, and he knows how crucial they can be. 

“Oftentimes I have truckers and if they’re traveling and they leave their CPAP mask, they have to have it immediately to get the proper rest in order to drive,” he said. 

Philips says to date, they’ve had no reports of death because of the issues.

But the company says potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. 

The company and local health care providers tell us they are working to help patients impacted.

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As far as the ventilators go, Memphis hospitals Methodist, Regional One and Baptist said they are not affected by the recall. Le Bonheur Childrens Hospital told us they’re in the process of reviewing the recall. 

Baptist Hospital said Philips has informed them that a website will go live tomorrow with more information on this issue.

“Patients should talk with their physician about whether they should continue using their device, and the website should help with these discussions. We continue to monitor this situation, and we are here to help patients get the medical equipment they need to live happy, healthy lives,” the hospital said.