Philips CPAP Recall Lawsuit | 2026 Latest Updates

Philips Respironics recalled millions of CPAP, BiPAP, and ventilator devices in June 2021. A foam part inside them could break down, exposing users to inhaled or swallowed particles and chemicals that lawsuits allege are linked to cancer and respiratory illness.

A consolidated multidistrict litigation, MDL No. 3014, has moved forward in federal court in Pennsylvania since October 2021. Personal-injury and medical-monitoring claims are being resolved under a settlement, and a second settlement compensates device purchasers.

As of September 2026, the litigation remains active, and the case is not close to finished. The court continues to enter new orders on settlement claims and on individual cases that did not settle.

Latest Philips CPAP Lawsuit Updates

September 9, 2026: MDL Court Approves Settlement Grant

The MDL court granted an unopposed motion approving an educational grant recommended by the settlement administrator for the personal-injury program (Doc. No. 4382). The order is the newest entry on the MDL 3014 docket.

It shows the court and the administrator continuing to manage claims processing for registered claimants, while litigating-plaintiff cases move through separate deadlines under the docket management order.

September 2, 2026: Court Appoints Lead Counsel for Litigating Plaintiffs

The MDL court entered an order appointing lead counsel for litigating plaintiffs (Doc. No. 4372). This smaller group of claimants did not register for the personal-injury settlement and is pursuing its cases individually.

Lead counsel now coordinates filings and scheduling for these plaintiffs. The order followed months of docket activity narrowing which claims remain in active litigation rather than the settlement program.

June 26, 2026: Court Dismisses 43 Litigating Plaintiffs

The MDL court granted Philips Respironics‘ motion to dismiss the claims of 43 litigating plaintiffs (Doc. No. 4292). They had failed to comply with a court order requiring them to show cause why their cases should continue.

The dismissal is one of several the court has issued this year against plaintiffs who missed the docket management order’s disclosure and evidence deadlines.

March 7, 2026: Canadian Settlement Claims Deadline Passes

The deadline passed to submit a claim with KPMG, the Canadian settlement’s claims administrator, for the Philips CPAP class-action partial settlement. It resolves economic-loss claims from Canadian purchasers and users of the recalled devices under Canadian law [1].

The administrator is now reviewing every submitted claim and expects to begin sending payments to approved claimants in May 2026, by e-transfer or cheque.

January 31, 2025: Personal-Injury and Medical-Monitoring Settlements Become Final

The deadline passed for eligible U.S. personal-injury claimants to register for the settlement program. Philips reported that registrations exceeded 95% of eligible claimants, making the settlement final.

The related $25 million medical-monitoring class settlement also became final that same month, according to the same company update. It funds research into the detection, diagnosis, and treatment of injuries linked to the recalled devices.

June 21, 2024: Settlement Identification Deadline Passes

The deadline passed for eligible personal-injury claimants to submit an Identification Order Declaration, the first step toward joining the personal-injury settlement program described above.

Claimants or their lawyers had to identify a qualifying injury by this date under the settlement administrator’s registration rules. Anyone who missed it could not register for or participate in the settlement without the parties’ express agreement.

May 9, 2024: Philips Agrees to $1.075 Billion Settlement

Philips Respironics agreed to pay $1.075 billion to resolve personal-injury claims filed in the MDL and in Massachusetts state court. The total includes a $1.05 billion settlement fund and $25 million in administrative costs.

The company separately agreed to a $25 million medical-monitoring class settlement. Judge Conti entered an Identification Order the same day directing how claimants would be identified.

April 11, 2024: Court Holds Hearing on $479 Million Settlement

The MDL court held the final-approval hearing on a proposed $479 million economic-loss class settlement described in the court’s settlement notice. It covers $445 million for device users and $34 million for payers such as health insurers [2].

The agreement was reached in September 2023 and compensates purchasers and payers for losses tied to buying, leasing, or renting a recalled device.

April 9, 2024: Court Enters Consent Decree Against Philips

A federal court entered a consent decree against Philips Respironics, restricting new CPAP, BiPAP, and ventilator production and sales at several of its Pennsylvania facilities until the company meets FDA compliance requirements.

The decree also requires Philips to complete its device repair, replacement, and refund program under an FDA-approved plan, using a new silicone foam, before the restriction is lifted.

January 29, 2024: FDA Statement on Consent Decree Agreement

The FDA’s Center for Devices and Radiological Health issued a statement on Philips Respironics’ announcement that it had reached an agreement in principle with the government on the consent decree.

The statement outlined what the agency expected the eventual court order to require of the company’s manufacturing and quality-system compliance. The announcement came about two months before the court entered the formal decree described in the entry above.

October 5, 2023: FDA Provides Recall Update

The agency’s device center provided an update on the June 2021 recall, stating it continued to maintain its existing recommendations about the potential health risks of PE-PUR foam breakdown.

It said it would keep reviewing incoming medical device reports and other data as its assessment of the recall continued, about four months before it announced the agreement in principle described above.

March 10, 2022: FDA Orders Direct Patient Notification

The FDA ordered Philips Respironics to directly notify patients about the recall of certain breathing assistance machines. Before this order, the company had relied only on health care providers and distributors to pass along the notification.

The order followed the agency’s finding that many affected patients had not yet been reached through the standard notification process, about eight months after its prior safety communication described below.

November 12, 2021: FDA Issues Updated Safety Communication

The FDA issued an updated safety communication on the recall, reiterating its recommendations for patients using an affected ventilator, BiPAP, or CPAP machine and for the health care providers who prescribe them.

The update summarized the agency’s evolving understanding of the potential health risks tied to the breakdown of the sound-abatement foam. It came about five months after the recall notice and roughly four months before the MDL transfer order described below.

October 8, 2021: MDL No. 3014 Is Established

The Judicial Panel on Multidistrict Litigation centralized federal Philips CPAP, BiPAP, and ventilator lawsuits into MDL No. 3014 (Doc. No. 1), based in the federal court for the Western District of Pennsylvania in Pittsburgh, before Judge Joy Flowers Conti.

The transfer order consolidated pretrial proceedings for the personal-injury, medical-monitoring, and economic-loss claims filed against the company up to that point. Later-filed cases were added to the MDL as they were transferred in.

June 23, 2021: Health Canada Issues Its Own Recall

Health Canada issued its own recall notice for the same CPAP, BiPAP, and ventilator models sold in Canada, nine days after the U.S. notification.

The Canadian notice set up a device registration process, with repairs and replacements coordinated through Philips’ network of Durable Medical Equipment Providers. It later formed the basis for the Canadian class-action litigation and the economic-loss settlement described above.

June 14, 2021: Philips Respironics Recalls CPAP and BiPAP Devices

Philips Respironics issued the voluntary U.S. recall notification for CPAP, BiPAP, and ventilator devices containing PE-PUR sound-abatement foam, affecting about 15 million devices worldwide [3].

The recalled product line included DreamStation, REMstar SE Auto, SystemOne, and several other models manufactured over roughly the prior decade. That same recall notice then prompted the litigation and regulatory history described throughout this update timeline.

What Is PE-PUR Foam?

PE-PUR foam is the polyester-based polyurethane foam Philips Respironics used inside certain CPAP, BiPAP, and ventilator devices, including the DreamStation line described above, to reduce noise and vibration. It can break down into particles a user may inhale or swallow.

The FDA has found the foam can also release volatile organic compounds, especially with heat, humidity, or unapproved ozone or UV cleaning [4]. Philips began replacing it with a different material after the 2021 recall.

Who May Be Affected?

People who used a recalled Philips Respironics CPAP, BiPAP, or ventilator device made between 2009 and April 2021 may be affected. This is especially true for those later diagnosed with a qualifying condition under the personal-injury settlement program.

The settlement’s qualifying injuries include several cancers, such as lung, leukemia, thyroid, and certain head-and-neck cancers. Other qualifying injuries include worsening asthma, chronic obstructive pulmonary disease, and pulmonary fibrosis or interstitial lung disease, though not every diagnosis qualifies.

An individual legal review is the only way to confirm whether a specific device, use period, and diagnosis meet the settlement’s or a new claim’s requirements.

Reported Injuries or Damages

The FDA has received more than 116,000 medical device reports connected to the PE-PUR foam breakdown since April 2021, including 561 reports of death, in data current through January 2024 [5].

Reported injuries include cancer, pneumonia, asthma, infection, headache, cough, difficulty breathing, dizziness, nodules, and chest pain, drawn from both mandatory manufacturer reports and voluntary reports from patients and providers.

Lawsuits allege the recalled devices’ foam caused or contributed to cancer and respiratory illness, though a medical device report does not by itself prove a device caused a specific injury.

Philips has said thirteen third-party epidemiological studies found no consistent statistical association between use of its devices and cancer risk in people with obstructive sleep apnea.

Recall and Regulatory Background

Philips Respironics recalled about 15 million CPAP, BiPAP, and ventilator devices worldwide on June 14, 2021, after finding the PE-PUR foam could degrade into particles and chemicals a user might inhale or swallow.

Health Canada confirmed the recall June 23, 2021, and the FDA classified it a Class 1 recall [6]. Philips’ repair-and-replacement program and its April 2024 consent decree remain in effect.

Evidence to Preserve

Anyone who believes a recalled Philips device contributed to an injury should keep the following records available for a lawyer to review:

• The device’s serial number and any confirmation from registering it in Philips’ recall and replacement program
• Purchase, lease, or rental records showing when, where, and from whom the device was obtained
• Medical records documenting the diagnosis, its date, and any treatment received for the alleged injury
• Photographs of the device, including any visible signs of foam degradation inside or around it
• Any communications with Philips, a health care provider, or a medical equipment supplier about the device or the recall
• Insurance, Medicare, or Medicaid documentation relevant to any lien that could apply to a settlement payment

Keeping these records together, organized, and dated gives a lawyer everything they need to evaluate the claim without unnecessary delay.

Filing Deadlines

Deadlines for filing an individual product-liability claim over a recalled Philips device come from state law, not from this settlement program’s own registration dates.

How much time a person has can depend on where they live and on when the exposure, illness, or diagnosis happened. Some states start the clock at diagnosis rather than at first use of the device.

The personal-injury settlement above has its own separate registration schedule. Missing a state-law deadline can end an otherwise valid claim even with strong facts, so anyone who believes they were harmed should talk to a lawyer promptly.

Potential Compensation

Compensation under the personal-injury settlement described above is allocated individually, not as a flat or average figure, based on a claimant’s qualifying injury, its severity, and supporting medical documentation.

The separate $479 million economic-loss settlement compensates device users and payers for purchase-, lease-, or rental-related losses. Anyone who registered late or was excluded from either settlement may still pursue an individual claim.

Compensation amounts vary by case. Past results do not guarantee future outcomes. A lawyer can identify which potential compensation categories apply.

Frequently Asked Questions

How Do I Get a Replacement Philips CPAP Device?

Getting a replacement Philips CPAP device means registering it through Philips’ recall website for repair, replacement, or a refund. In Canada, the registration portal closed at the end of December 2024, with the repair-and-replacement program targeted for completion by the end of June 2025.

Are There Philips CPAP Lawsuits Outside the United States?

Yes, there are Philips CPAP lawsuits outside the United States. Philips Respironics faces consumer class actions in Australia, Canada, and Israel, plus collective or individual actions in several European countries alleging economic loss or personal injury. An Italian class action was declared inadmissible on both first instance and appeal.

What Happens If Someone Is Excluded from the Personal-Injury Settlement?

Someone excluded from the personal-injury settlement, or who chose not to participate, must identify themselves to the court and comply with strict orders requiring early disclosure of their evidence on causation. Their case then proceeds as an individual lawsuit in the MDL rather than through the settlement program.

What Does Philips’ Consent Decree with the FDA Require?

Philips’ consent decree with the FDA requires the company to retain independent quality-system experts to oversee its compliance program. Philips may still service existing devices and sell masks and other accessories in the U.S. before the restriction described above is lifted.

Is Philips Respironics Facing Other Legal or Financial Fallout from the Recall?

Yes, Philips Respironics faces legal and financial fallout from the recall. The Department of Justice opened a criminal and civil investigation in 2022. The SEC issued a subpoena in March 2024, and in 2024 Philips and its insurers agreed to a 540 million euro contribution toward recall-related costs.

Are There Securities Lawsuits Related to the Philips CPAP Recall?

Yes, there are securities lawsuits related to the Philips CPAP recall. A securities class action was filed against Philips, its former CEO, and its former CFO on August 16, 2021, in the Eastern District of New York. The court dismissed some claims but allowed others to proceed.

What Do Studies Say About Philips CPAP Devices and Cancer Risk?

Studies say there is no consistent statistical association between Philips CPAP devices and cancer risk. Thirteen third-party epidemiological studies found this, including a 2021 study in the American Journal of Respiratory and Critical Care Medicine and a 2022 European Respiratory Journal study.

References

1. https://cpapsettlement.kpmg.ca/
2. https://www.pawd.uscourts.gov/sites/pawd/files/3014_Settlement.pdf
3. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/philips-issues-recall-notification-mitigate-potential-health-risks-related-sound-abatement-foam
4. https://www.fda.gov/medical-devices/recalled-philips-ventilators-bipap-machines-and-cpap-machines/foam-testing-summary-recalled-philips-ventilators-bipap-machines-and-cpap-machines
5. https://www.fda.gov/medical-devices/recalled-philips-ventilators-bipap-machines-and-cpap-machines/problems-reported-recalled-philips-ventilators-bipap-machines-and-cpap-machines
6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=187815