A major medical device manufacturer has issued a recall of CPAP machines for sleep apnea sufferers due to potential health risks.

On June 14, Amsterdam-based Royal Philips NV issued a recall for certain Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices due to possible health risks associated with sound-dampening polyester-based polyurethane foam used in the devices.

The company says that the foam “may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.”

The inhaled foam could cause “headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects.” Chemicals inhaled through off-gassing may cause “headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects.”

Royal Philips says that they have no confirmed reports of any health issues caused by their medical devices at this time.

The Wall Street Journal reports that the recall affects three to four million medical devices, about half of which are in the United States. Philips says that most of the recalled devices are DreamStation products.

As part of the recall, the company will replace the sound-dampening foam with an alternative material. For now, however, Royal Philips is recommending that users of the BiLevel PAP and CPAP devices discontinue use and consult with their doctors about the best option for treatment moving forward.

“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” said Frans van Houten, CEO of Royal Philips. “In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. Patient safety is at the heart of everything we do at Philips.”

For additional information about the recall, please click here.