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CPAP Machine FDA Recall

Throughout the nation, people suffer from lack of sleep or health conditions such as sleep apnea, where they are forced to rely on technological devices or external treatments to attain an adequate amount of rest. A study by J Clin Sleep Med found 50-70 million adults in the U.S suffer from a sleep disorder, and obstructive sleep apnea is one of the most common types of sleep disorders. It is also revealed that over 100 million people worldwide suffer from sleep apnea.

CPAP devices continue to be one of the most effective treatments for sleep apnea and improve the quality of life for those who suffer from this disorder. However, does the cost outweigh the benefits?

Phillips Respironics Recall

In June 2021, Philips Respironics recalled specific ventilators, BiPap, and CPAP machines due to potential health risks. In these affected devices, a polyester-based polyurethane foam utilized in these machines mainly for sound reduction has been discovered to degrade into tiny particles. The degradation of foam can slowly enter into a user’s airway if swallowed or ingested, result in a severe injury, or develop into a chronic health condition.

Potential Health Risks from Sound Abatement Foam

Polyester-based polyurethane (PE-PUR) foam is primarily used to lessen the sound and vibration in these machines. However, the foam that breaks down has toxic and carcinogenic effects, which could lead to devastating and life-threatening outcomes if inhaled. The foam can emit hazardous chemicals and significantly affect the user’s bodily functions.

There are potential risks associated with this sound abatement foam:

  • Foam degradation into black pieces may enter the device’s airways and be ingested by the user.

  • The foam may release dangerous chemicals such as volatile organic compounds that severely irritate the user’s nose, eyes, and throat. Some of these chemicals can lead to cancer.

  • The damage of the foam can worsen in hot and humid temperatures.

  • The black pieces from the foam degradation may not be visible in the mask and air tubes of the machine.

Potential Health Risks of Swallowing The Foam Pieces

The dangers of being inhaling the Polyester-based polyurethane (PE-PUR) foam include:

  • Inflammatory response.

  • Headache.

  • Asthma.

  • Toxic or carcinogenic effects to kidneys, organs, and liver.

  • Irritation to the eyes, skin, nose, and respiratory tract.

Potential Health Dangers of Exposure To Chemicals

If a user inhales chemicals from the (PE-PUR) foam, it may potentially cause severe side health side effects:

  • Dizziness.

  • Headache.

  • Hypersensitivity or allergic reactions.

  • Nausea.

  • Cancer.

Since April of 2021, the FDA has reported over 3,000 medical device reports related to foam degradation.

There has been a wide range of severe outcomes that have been reported to the FDA, including:

  • Cancer.

  • Asthma.

  • Pneumonia.

  • Respiratory issues.

  • Infection.

  • Cough.

  • Difficulty breathing.

  • Chest pain.

  • Nodules.

Reporting Your Affected Device

Suppose you possess a Phillips Respironics device and have a chronic health condition or any of the health issues listed above. In that case, the FDA recommends seeking medical attention immediately and discussing the problems with your healthcare provider. The FDA also encourages reporting your problem with the affected device through the MedWatch Voluntary Reporting Form.

Registering Your Affected Device

The FDA also advises the next steps after discovering your device has been affected by the recall.

  1. Read the FDA’s recommendations for the machine you own.

  2. Speak with your health care professional to decide if you should refrain from using this machine or decide on alternative sleep disorder treatments.

  3. Find your machine’s serial number.

  4. Enter your device’s serial number; this will reveal if your device is one of the defective machines.

  5. Register your device by visiting, Urgent: Field Safety Notification on the Philips Respironics website.

Contact Starkville Product Liability Lawyers

Vollor Law Firm, P.A. has over 20 years of legal experience helping victims who have been injured by defective products get the justice they deserve. If you or a loved one were harmed by CPAP devices or affected by the Phillips Respironics recall, we have the legal resources to fight on your behalf. Contact us today at (662) 269-6188 to schedule your free case consultation.