What Did the Maker of the Recalled CPAP Machines Know, and When?

What Did the Maker of the Recalled CPAP Machines Know, and When?

In June 2021, Philips Respironics issued a recall of over 15 million CPAP and BiPAP machines and ventilators due to the presence of black debris in the device’s air pathway that was causing adverse health problems to users. This led Philips to determine that the PE-PUR sound abatement form used to minimize noise in its machines could break down and cause users to inhale or swallow the foam particles and chemical emissions.

But what did the maker of recalled CPAP machines know, and when? Based on company records, Philips employees were concerned about the integrity of the foam years before the recall was issued.

Since Philips initiated the recall over two years ago, the U.S. Food and Drug Administration (FDA) has received over 105,000 medical device reports associated with the degraded or suspected degradation of the PE-PUR foam. The reports include adverse events, including cancer, pneumonia, asthma, infection, and other respiratory problems, as well as 385 deaths.

What Did Philips Respironics Know About the Recalled CPAP Machines?

Philips announced the recall of millions of CPAP and BiPAP Machines and ventilators in June 2021. The initial recall involved 20 different types of breathing machines manufactured before April 26, 2021. The company said that the issues “can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.” At that point, Philips said it had received reports of headache, upper airway irritation, cough, chest pressure, and serious infection.

Philips further cautioned that potential risks of particle exposure include:

  • Skin, eye, and respiratory tract irritation
  • Inflammatory response
  • Headache
  • Asthma
  • Adverse effects to other organs (kidneys, liver)
  • Toxic carcinogenic effects

The foam was also prone to releasing chemicals as a vapor into the air, a process known as off-gassing. The potential risks of chemical exposure to off-gassing include:

  • Headache/dizziness
  • Eye, nose, respiratory tract, skin irritation
  • Hypersensitivity
  • Nausea/vomiting
  • Toxic and carcinogenic effects

The FDA issued a Safety Communication announcing that it was analyzing medical device reports from 2009 to 2021 for issues that could be related to the PE-PUR foam degradation issue. The agency classified the recall as a Class I, the most serious type of recall. This means there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

So, how long before the recall did Philips know about the CPAP defect? In a Q1 2021 quarterly report filed on April 26. 2021, Philips disclosed for the first time that users of its sleep apnea devices had reported adverse health effects after using the machines. Those reports led to the discovery that the sound abatement form could break down into black debris within the devices’ air pathways. The company announced the recall nearly two months later.

But an internal email between a Philips employee and a foam supplier dating back to 2015, specifically discusses the sound abatement foam degradation issues.

Philips Respironics Faces Hundreds of CPAP Lawsuits for Failure to Warn

Those harmed by Philips BiPAP and CPAP machines began filing CPAP lawsuits against Philips claiming the company knew of the health risks associated with its defective CPAP machines long before it initiated the recall. And because Philips failed to warn consumers that they were at risk of breathing in carcinogenic foam particles, the company may be held liable for the damages and harm caused by their defective breathing machines.

At least 548 Philips CPAP lawsuits are currently pending in federal court in the Western District of Pennsylvania. However, with the second anniversary of the first CPAP recall now past, it is likely that date will be used by courts to begin the statute of limitations clock. That means injured users of recalled CPAPs who live in states with a 1- or 2-year statute of limitations who haven’t already filed a lawsuit may no longer be eligible to file a case in civil court. If you’ve been affected by the recalled CPAP machines, contact a lawyer to see if you still qualify for a CPAP lawsuit.

What CPAP Machine Was Recalled?

The CPAP recall involves the following ventilators and CPAP and BiPAP machines:


Continuous Ventilator

  • Trilogy 100
  • Trilogy 200
  • Garbin Plus, Aeris, LifeVent

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

  • A-Series BiPAP Hybrid A30 (not marketed in the U.S.)
  • A-Series BiPAP V30 Auto

Continuous Ventilator, Non-life Supporting

  • A-Series BiPAP A40
  • A-Series BiPAP A30

CPAP and BiPAP Devices

Continuous, Minimum Ventilatory Support, Facility Use

  • E30 (Emergency Use Authorization)

Continuous, Non-Life Supporting

  • SystemOne ASV4
  • C-series ASV
  • C-Series S.T and AVAPS
  • DreamStation ASV
  • DreamStation ST, AVAPS
  • OmniLab Advanced+


  • Dorma 400
  • Dorma 500
  • REMstar SE Auto
  • SystemOne (Q-Series)
  • DreamStation
  • DreamStation Go

Philips Respironics also recalled previously recalled, reworked, and reissued Trilogy 100 and Trilogy 200 ventilators. The recall was issued after the company discovered issues with the silicone sound abatement foam used to replace the defective PE-PUR foam separating from the plastic backing and posing a risk of airway blockage. Some reworked machines were also found with residual PE-PUR sound abatement foam.

Harmed by a Recalled Philips CPAP Machine? Contact an Experienced Lawyer Today

If a defective CPAP machine has injured you or someone you love, it is important to seek legal help right away. An attorney can help you understand your legal options and fight for the compensation you deserve.

The mass tort lawyers at Lawsuit Legal News have years of experience helping people like you seek the compensation they deserve from the companies who harmed them. Contact us today at 866-467-0943 or complete our online contact form for a free case consultation.


Matthew Dolman

Personal Injury Lawyer

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has represented over 11,000 injury victims and has served as lead counsel in over 1000 lawsuits. Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

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