Philips Respironics Recalls Millions of CPAP, Breathing Machines

• August 9, 2021
• Defective Products, FDA, Product Liability

One in 15 adults in the United States – roughly 18 million people – suffer from obstructive sleep apnea. One of the most common treatments is using a CPAP machine which keeps the airway open with a gentle, constant stream of pressurized air. However, in June, millions of CPAP and other breathing devices made by Philips Respironics were recalled due to possible health risks and potential dangerous sound abatement foam.

Philips Respironics Recalls CPAP Machines, Possible Cancer Risk

On June 14, 2021, Philips Respironics announced a voluntary recall for a number of Philips CPAP, BiPAP, and mechanical ventilator devices due to potential health risks related to polyester-based polyurethane (PE-PUR) sound abatement foam used in these machines. Specifically, the sound abatement foam may:

1. break down into black particles that can enter the device’s mask, tubing, or air pathway and be inhaled or swallowed by the user
2. off-gas certain chemicals that are dangerous and potentially carcinogenic

The FDA issued a Safety Communication on June 30, 2021; then, on July 29, 2021, the FDA identified this as a Class I recall, the most serious type of recall.

Philips Respironics has received several complaints about the presence of black debris/particles within the device’s air pathway along with reports of headache, upper airway irritation, cough, chest pressure, and sinus infection, which may be related to this issue, though the cause of the symptoms cannot be definitively linked.

According to the FDA Recall Notice, there have been more than 1200 complaints and more than 100 injuries reported for this issue.

Potential Health Risks, Recalled Devices

Defective or degraded sound abatement foam in these recalled Philips Respironics devices may expose users to toxic chemicals potentially leading to serious health complications, such as:

• Cancer (lung, kidney, liver, colon, and others)
• Respiratory Failure
• Kidney Disease
• Liver Disease
• Heart Attack, heart failure, or stroke
• Asthma

Possible Chemical Emission Includes:

• Toluene diamine: Compound used to make polyurethane, dyes, hydraulic fluid, and sensitizers for explosives. Health hazards include Genetic defects, skin reactions, toxicity, cancer, damaged fertility, and organ damage.
• Toluene diisocyanate: Liquid for making foams and coatings. Health hazards include Cancer, eye damage, skin irritation, respiratory irritation and may be fatal if inhaled.
• Diethylene glycol: Solvent used in the manufacturing of other chemicals that can irritate skin, eyes, and mucous membranes and may be slightly toxic if swallowed.

Use our online Case Evaluation Request form to request a free consultation and case review.

Listing of Recalled Machines

Most of the devices come from Philips’ DreamStation line. The recall affects all serial numbers of the following affected devices (18 products) manufactured between 2009 and April 26, 2021. 80% of the recalled devices are CPAP machines.

Need Legal Assistance? Start Your Free Case Evaluation Today

If you’ve used Philips Respironics sleep devices and experienced any of the health issues listed above, you may be able to pursue financial compensation through a Philips CPAP lawsuit.

Having an attorney who is your advocate can offer you peace of mind. We have a successful track record of helping those who have suffered personal injuries collect the compensation they deserve. Call the Nash & Franciskato Law Firm at (877) 284-6600. One of our experienced staff will speak with you personally and will provide you with a free, no-obligation case evaluation.

START YOUR FREE CASE EVALUATION TODAY

RESOURCES FOR YOU

• FDA Safety Communication
• Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions
• Find related blog articles: Defective Products and Product Liability

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