What to Know About Philips CPAP and Ventilator Recall

Editor's Note: This article was updated on April 12, 2022.

In June 2021, Philips Respironics announced a recall for many of its devices. The medical device company analyzed risks related to several products. These products include both continuous and bilevel positive airway pressure (CPAP and BiPAP) machines as well as mechanical ventilator devices.^1,2

Philips found that a foam used to reduce sound may break down and enter the air pathway. This foam may have health risks when inhaled. In September 2021, the Food and Drug Administration (FDA) announced that Philips could begin replacing or repairing the devices.³

Talk to your doctor about what to do if you use an affected device. They may suggest using a similar device or other treatments while you wait for a replacement.

FDA puts pressure on Philips

In March of 2022, the FDA determined that Philips’s recall notification efforts have not been good enough. The FDA ordered Philips to notify the following groups about the company’s recall and health risks linked to the foam:^4,5

• Users of the devices
• Medical equipment suppliers
• Distributors
• Retailers
• Doctors

Philips must also include information on the risk of using ozone cleaners on the recalled devices.^4,5

Why were these devices recalled?

The ventilators and machines were recalled because of the “sound abatement foam” used in them. The foam is made out of polyester-based polyurethane. It decreases sound and reduces vibrations caused by the device during use.^2,6

After reviewing user reports and lab data, Philips found that the foam may have health risks. It may break down into small particles that enter the airway during use. Inhaling the foam particles can cause:^6,7

• Irritation to airways, eyes, and skin
• Sinus infections
• Headache
• Asthma
• Kidney or liver problems

The foam can also create other gasses while the device is in use. These gasses can reach unsafe levels and cause:⁶

• Nausea or vomiting
• Headache
• Dizziness
• Irritation to airways, eyes, and skin
• Allergic reactions

As of March 2022, there have been no reports of death. There have been reports of minor symptoms or black residue in the devices. Storing the devices in hot or humid climates may cause a greater risk. Cleaning the device with unapproved methods may also increase the risk.^1,2,5

How do I know if my device is affected?

Not all Philips CPAP, BiPAP, and mechanical ventilator devices are recalled. To see if your device has been recalled, visit the Philips website or the FDA recall notification.

How do I get a replacement device?

To get your device replaced or repaired, register it with Philips by following the instructions on the Philips website.

During the registration process, you can look up your device serial number and begin a claim. You can call Philips at 1-877-907-7508 to complete this process.¹

When will my device get replaced or repaired?

It is unclear how long the repair and replace program will take. The FDA states there has not been enough communication about device repair and replacement information. The FDA recommends Philips provide monthly updates to device users who register their devices with detailed replacement information.^4,8,9

Philips started the repair and replacement program in September 2021. Officials from Philips say the repair and replacement program will take about a year to complete.^3,8

Unfortunately, there are shortages of many of the recalled devices. The availability of replacement machines is limited due to COVID-19. Replacing the foam may be quicker than waiting for a replacement machine.^8,9

How do I know the repaired device is safe?

The FDA inspects Philips manufacturing facilities to make sure they comply with regulations. The FDA requires Philips to provide evidence of the safety and effectiveness of its repairs.⁸

Unfortunately, things got a little more complicated when the FDA identified another potential safety risk. They issued a statement about safety concerns for a new foam used in the repair and replace program.^5,8

Some people already have devices with the new foam installed. At this time, the FDA does not recommend that people who have participated in the repair and replace program stop using their devices.^5,8

What do I do if I cannot wait for a replacement device?

First, confirm that your device is included in the recall. If your device is on the recall list and you cannot wait for a repair or replacement, talk to your doctor. They may suggest:^2,8

• Using a similar device that is not part of the recall
• Using alternative treatments for sleep apnea
• Starting long-term therapies for sleep apnea
• Continuing to use the recalled device if your doctor determines that benefits outweigh risks

Follow the recommendations for storing and cleaning your device. Do not try to remove the foam yourself. Do not stop or change your device use without talking to your doctor first.^5,8