CPAP/BIPAP Recall

URGENT RECALL: Philips Recalls CPAP and BiPAP Machines Due to Toxic Particles

Millions of Philips breathing machines have been recalled.  The Philips CPAP and BiPap devices—like the first-generation DreamStation —use polyester-based polyurethane (PE-PUR) foam to muffle the machine’s noise. Over time the foam can disintegrate into particles or emit chemical gases that the user may ingest or inhale while sleeping. These particles are toxic, potentially carcinogenic, and pose a risk to human health and life.

This risk is so severe that the FDA has designated the recall as Class I, which is the most serious type of recall and indicates the device may cause serious injuries or death.

If you have been diagnosed with cancer or a serious respiratory disease after using a Philips CPAP, Philips BiPAP, or Philips Ventilator, the experienced defective medical device attorneys at The Cochran Firm can help you receive the compensation you deserve. Contact The Cochran Firm today for a free, no-obligation initial consultation. Our lawyers provide free, confidential consultations, and if we are fortunate enough for you to hire us, we never will charge you any fees or costs unless you first recover.

What Devices Have Been Recalled?

In June 2021, the Dutch medical equipment manufacturer Philips (Koninklijke Philips N.V. and Philips Respironics) recalled most of its CPAP (Continuous Positive Airway Pressure) and Bi-Level PAP (Bilevel Positive Airway Pressure) devices, as well as some ventilators, manufactured between 2009 and April 2021. The following devices are being recalled: 

• E30 (Emergency Use Authorization)
• *DreamStation ASV
• *DreamStation ST, AVAPS
• SystemOne ASV4
• C Series ASV, S/T, AVAPS
• OmniLab Advanced+ In-Lab Titration Device
• SystemOne (Q series)
• *DreamStation CPAP, Auto CPAP, BiPAP
• *DreamStation GO CPAP, APAP
• Dorma 400, 500 CPAP
• REMStar SE Auto CPAP
• Trilogy 100 Ventilator
• Trilogy 200 Ventilator
• Garbin Plus, Aeris, LifeVent Ventilator
• A-Series BiPAP V30 Auto Ventilator
• A-Series BiPAP A40
• A-Series BiPap A30

*The second-generation DreamStations are not currently subject to a recall.  

Why Are the Devices Being Recalled? 

The recalled CPAP and BiPAP devices and Ventilators each use a polyester-based polyurethane (PE-PUR) foam to reduce the sound and vibration produced by the machines. This type of foam can degrade over time, disintegrating into tiny particles and emitting (outgassing) chemicals. If this occurs, black debris from the foam or certain chemical gases may be released into the device’s air pathway and unknowingly inhaled or swallowed by the person using the device. Philips Respironics admits it has received several complaints about black debris/particles within the device’s airway. 

Philips has suggested that the disintegration of the foam may be worsened by certain environmental conditions involving high humidity and temperature and unapproved cleaning methods (e.g., ozone cleaners, ultraviolet light products). 

According to the FDA, the shedding of the foam particles and chemicals can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent injury. Reported adverse health effects include serious respiratory inflammation and irritation that may directly result from the toxic and carcinogenic effects of chemicals produced by the machines being inhaled. Philips has also acknowledged that exposure and inhalation of these toxic chemicals can cause headaches, irritation, hypersensitivity, nausea, and vomiting. Potential risks of exposure include adverse effects to the lungs, kidneys, liver, respiratory disease, and cancer. 

What Should You Do If You Have Used One of the Recalled Devices?

Both Philips and the FDA recommend the following:

• See your doctor immediately: Do not stop or alter your prescribed therapy until you have talked to your physician. In some situations where the ventilators provide life-sustaining therapy or therapy disruption is unacceptable, the benefits of continued usage of these ventilator devices may outweigh the risks.

• Consider alternatives: Talk to your health care providers to decide on a suitable treatment for your condition, which may include: stopping use of your device, using a similar device that is not part of the recall, and alternative treatments for sleep apnea.

• Philips recommends using an inline bacterial filter If your physician determines that you must continue using the recalled device. The FDA, however, warns that it has no evidence of the safety and effectiveness of a filter to mitigate the risks. While a filter may help filter out the particles, it will not help reduce outgas of chemicals released from the foam. The filters may also affect the device’s performance by increasing the resistance of airflow through the device. The FDA recommends closely monitoring for possible accumulation of foam debris on your filter and resistance-related problems in the breathing circuit after filter replacement.

• No DIY.  Do not remove the sound abatement foam as that may impact the device’s performance and possibly introduce foam debris into the device.

How Can The Cochran Firm Help You?

The Cochran Firm is now accepting potential cases from people who used one of the recalled devices for more than one year and have been diagnosed with a permanent injury or disease caused by exposure to the defective CPAP, BiPAP, or Ventilator. We will review your relevant medical records and the circumstances surrounding your use of the breathing device(s) to determine whether we believe a lawsuit brought on your behalf would be feasible. 

The recall is based, at least in part, on potential carcinogenic risk from foam particles or gases. The cancers we are currently accepting for investigation and evaluation include:

The Cochran Firm is also evaluating cases involving serious respiratory injuries, such as:

Why Choose The Cochran Firm?

Our law firm has been in existence for more than 40 years and is considered a national leader in this type of litigation. We expect to work directly with the Plaintiffs’ Executive committee overseeing the federal lawsuits involving the Philips recalled devices. This means that we will be directly involved in the national investigation and discovery that will hopefully result in a positive outcome for the individuals injured by this product.

We have substantial experience litigating cases involving medical device defects, pharmaceutical defects, and product defects in mass torts and single-event cases. These cases have collectively resulted in multi-million dollar jury verdicts, settlements, and compensation for personal injury and/or death against some of the largest manufacturers of medical devices, pharmaceuticals, and other products. 

Our firm is about helping regular folks who have been injured by defective products, making sure that the manufacturers that cause an injury to you or a loved one are held accountable for designing, marketing, and selling defective devices. 

Contact The Cochran Firm today for a free, no-obligation initial consultation. Our lawyers provide free, confidential consultations, and if we are fortunate enough for you to hire us, we never will charge you any fees or costs unless you first recover.

Please refer to the sources below for more information about the link between respiratory issues and a Philips CPAP or BiPAP machine.

Center for Devices and Radiological Health, “Certain Philips Respironics Ventilators, BiPAP, CPAP MACHINES RECALLED,” U.S. Food and Drug Administration, (30 June 2021). https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks

Center for Devices and Radiological Health, “Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals,” U.S. Food and Drug Administration, (2021, July 22). https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-continuous-and-non-continuous-ventilators-including-cpap-and