CPAP & BiPAP Defects

In 2021, Philips recalled millions of CPAP, BiPAP and ventilator machines because sound-dampening foam could break down into particles and chemicals. In 2025, certain reworked DreamStation machines were recalled for a separate programming error. These are different problems, and neither applies to every breathing machine. A CPAP lawyer looks at which machine was used, for how long, and what doctors have found.

What CPAP and BiPAP machines do

CPAP (continuous positive airway pressure) machines blow air at a steady pressure to keep the airway open during sleep, most often for sleep apnea. BiPAP (bi-level) machines use two pressures, one for breathing in and one for breathing out. Some ventilators work in similar ways. These machines are used every night, often for years, so a problem can affect a person over a long time.

Two different Philips problems

Philips Respironics has had two separate safety issues that are often confused:

The 2021 foam recall

In June 2021, Philips recalled certain ventilators, BiPAP machines and CPAP machines because the polyester-based polyurethane (PE-PUR) foam used to reduce sound and vibration can break down. The FDA says about 15 million devices were affected worldwide1.

If the foam breaks down, black pieces can enter the air tubes and be breathed in or swallowed, and chemicals called volatile organic compounds can be released. Heat and humidity may speed breakdown, and cleaning methods not recommended by the manufacturer, such as ozone cleaners, may make it worse. The FDA lists potential risks including irritation of the skin, eyes, nose and airway, inflammatory response, headache, asthma, and toxic or cancer-causing effects; chemicals may also cause dizziness and hypersensitivity reactions1.

Those are potential risks, not findings about any one person. In October 2023 the FDA said Philips' testing wasn't adequate to fully evaluate the risks, and Philips agreed to more testing3. A foam exposure alone doesn't establish that a machine caused anyone's cancer or other illness; that requires medical evidence specific to the person.

On April 9, 2024, a federal court entered a consent decree against Philips Respironics. It requires a recall remediation plan that gives affected patients a new or reworked device or, for certain devices, a partial refund, and restricts production and sale of new sleep and respiratory devices at certain Philips facilities until requirements are met1.

The DreamStation programming recall

In 2025, Philips recalled certain DreamStation Auto CPAP and Auto BiPAP machines because a programming error was introduced during rework by a supplier. Affected machines may run the wrong therapy mode (for example, a BiPAP set up as a CPAP), deliver limited pressure, or have features, sensors or humidifiers that don't work properly. The FDA lists possible consequences including hypoventilation, disrupted sleep, skin or airway burns and ineffective treatment of sleep apnea, and reported three injuries and no deaths. Philips told customers to keep using the device until a replacement arrived, then return the affected machine2.

That means a replacement machine can have its own, separate problem. A review tracks every machine a person used, including originals, repaired devices and replacements.

CPAP litigation

Federal cases are coordinated in MDL No. 3014 before Judge Joy Flowers Conti in the Western District of Pennsylvania. The court has handled three kinds of claims separately. It granted final approval of a class settlement of economic loss claims on April 25, 2024, and of a class settlement of medical monitoring claims on Nov. 13, 2024. Personal injury claims by individual plaintiffs proceed under a docket management order entered May 1, 2024, with deadlines for plaintiffs who join the MDL4.

The JPML's Nov. 2, 2026 report lists 626 actions pending in MDL No. 30145. Whether a new personal injury claim is possible depends on the facts, the dates, the court's orders and any earlier claim or release. Registering a device for replacement is not the same as filing a legal claim.

Who may have a CPAP or BiPAP claim

• Use of a recalled machine, confirmed by serial number, over a documented period
• A diagnosis that a doctor has evaluated in light of that use
• Injury from a reworked machine running the wrong settings
• Burns, breathing problems or hospital care tied to a malfunction

Who may be responsible

An investigation may look at the device maker and, for reworked machines, the supplier that did the work. Equipment suppliers who handled replacements may also have records.

Filing deadlines for CPAP lawsuits

Deadlines depend on your state, when you learned of the problem and its possible cause, and any court orders in the MDL. Examples:

• Arizona: generally two years for personal injury and wrongful death6.
• California: two years for injury to or death of a person caused by another's wrongful act or neglect7.
• New York: three years for personal injury8, with a separate rule that runs from discovery for injuries caused by the latent effects of exposure to a substance in the body9.
• Texas: two years for personal injury and wrongful death10, and most product liability claims must be brought within 15 years of the product's sale11.

When the clock starts can depend on when a person knew, or should have known, about the injury and its possible cause. Rules for minors, wrongful death and claims against public hospitals can differ. A device that was part of an earlier settlement can raise its own questions. Ask a medical device attorney to check the rules for your state early, before records are lost.

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Records that help a CPAP review

Records worth gathering

Machine

• Model and serial number
• Recall registration confirmation number
• Supplier records and dates of use

Replacement

• Replacement or rework letters
• Serial number of any replacement
• Return shipping records

Health

• Diagnoses and treatment
• Sleep doctor notes
• Any earlier claim or settlement papers

What happens after you contact CBW Law

How a review works

1. Tell us what happened

   Share what you remember about the machine, the problem and the treatment that followed. You do not need every record first.

2. We identify the device

   We work to confirm the maker, model and lot or serial number, and whether any recall or safety notice covers it.

3. We gather records

   With your permission, we request operative reports, imaging, device data and other records from your providers.

4. We explain what we see

   We tell you what the records show, what questions remain and what options may be open, including deadlines.

Using a recalled machine is not, by itself, proof that it caused an illness. Medical evidence about the person comes first.

Plain English

Medical, Health & Insurance

Terms you may see in a CPAP case.

Device terms

PE-PUR foam

Polyester-based polyurethane foam used to reduce sound and vibration1.

VOCs

Volatile organic compounds, chemicals that can be released as a gas.

Rework

Repairing or modifying a device after it was made.

Health terms

Sleep apnea

Breathing that stops and starts during sleep.

Hypoventilation

Breathing too shallow or slow to clear carbon dioxide.

Legal terms

Consent decree

A court order that a company agrees to follow.

Medical monitoring

A claim seeking the cost of future medical checkups after an exposure.

Questions

CPAP lawsuit questions

Short answers to the questions people ask first.

Are all CPAP machines affected?

No. The recalls cover certain Philips models and serial numbers.

Can a replacement machine have a problem?

Yes. Certain reworked DreamStation machines were recalled in 2025 for a programming error.

Does registering my machine mean I filed a claim?

No. Recall registration is for a replacement, not a legal claim.

Did the foam cause my cancer?

The FDA lists cancer-causing effects as a potential risk, but a link has to be shown with medical evidence about you. A CPAP lawyer can review your records.

Should I stop using my CPAP?

Talk to your health care provider first. The FDA says that decision should be made with your provider.

What settlements were approved?

The court approved class settlements of economic loss claims in April 2024 and medical monitoring claims in November 2024. Personal injury claims proceed separately.

Do I need a CPAP attorney if I already got a replacement?

A replacement doesn't resolve an injury claim. A CPAP attorney can review your history.

How long do I have to file a CPAP lawsuit?

It depends on your state, your dates and court orders in the MDL.

How do I find my serial number?

It's on the device label. Philips and your supplier can also help.

What does it cost to contact CBW Law?

Telling us your story costs nothing, and contacting us does not create an attorney-client relationship.

Tell Us Your Story

If you were hurt after using a recalled CPAP or BiPAP machine, a CPAP attorney can review what happened.

Tell us what happened. CBW Law will review your information and explain what we see. Submitting information does not establish an attorney-client relationship or guarantee representation.

Tell Us Your Story →Call (800) 476-2416

This page is general information about CPAP and BiPAP recalls. It is not legal or medical advice and does not create an attorney-client relationship. Using a recalled machine does not, by itself, establish that it caused an illness or that anyone is legally responsible. Do not stop prescribed breathing therapy without your provider's advice. Laws and deadlines differ by state, and no outcome can be promised.