REMStar SE Auto CPAP Recall Lawsuit (Sep 2026 Update)

Philips Respironics is recalling its REMstar SE Auto CPAP and BIPAP machines which were sold with sound abatement foam which may degrade over time, potentially resulting in severe injuries including cancer, respiratory damage and other serious health effects. There have been more than 1200 complaints and more than 100 injuries reported for this issue.

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Table of contents
  1. Latest REMStar SE Auto CPAP Lawsuit Updates
  2. September 2, 2026: MDL Court Appoints Lead Counsel for Litigating Plaintiffs
  3. June 26, 2026: MDL Court Dismisses Claims of 43 Non-Compliant Plaintiffs
  4. April 15, 2026: Philips Issues a Remediation Progress Update
  5. March 7, 2026: Canadian Settlement Claims Period Closes
  6. January 31, 2025: U.S. Personal-Injury Settlement Becomes Final
  7. December 5, 2024: Medical-Monitoring Settlement Gets Final Approval
  8. June 21, 2024: Amended Deadline Passes to Join the Personal-Injury Settlement
  9. May 9, 2024: Philips Respironics Agrees to a $1.075 Billion Settlement
  10. April 25, 2024: Economic-Loss Settlement Receives Final Court Approval
  11. April 9, 2024: Federal Court Enters a Consent Decree Against Philips
  12. March 10, 2022: FDA Orders Philips to Notify Patients Directly
  13. October 8, 2021: JPML Consolidates Federal Lawsuits into MDL 3014
  14. June 14, 2021: Philips Respironics Recalls REMStar SE Auto and Related Devices
  15. What Is PE-PUR Foam?
  16. Who May Be Affected?
  17. Reported Injuries or Damages
  18. Recall and Regulatory Background
  19. Evidence to Preserve
  20. Filing Deadlines
  21. Potential Compensation
  22. Frequently Asked Questions
  23. Can I Still File a Philips CPAP Lawsuit?
  24. How Many Devices Did the Philips Respironics Recall Cover?
  25. Does the Consent Decree Stop Philips from Selling CPAP Machines?
  26. What Did the 2022 Palm Study Find About PAP Device Use?
  27. Are There Philips CPAP Lawsuits Outside the United States?
  28. What Other Philips Respironics Devices Were Recalled with REMStar SE Auto?
  29. How Do I Register a Recalled REMStar SE Auto Device?
  30. References
REMStar SE Auto is a Philips Respironics CPAP device Philips recalled in 2021 over sound-abatement foam that can break down. Plaintiffs say the foam released particles and chemicals users breathed in or swallowed, linked to respiratory harm and cancer risk. Former users and their families pursued personal-injury and class-action claims against Philips Respironics. The cases were combined into a federal multidistrict case, MDL No. 3014, based in the Western District of Pennsylvania. Philips Respironics later reached a $1.075 billion settlement covering personal-injury claims, plus separate economic-loss and medical-monitoring settlements. The personal-injury and economic-loss funds already paid claimants who registered on time, and the case stays open for others.
Lawsuit at a glance
  • Case or litigation name: In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation (MDL No. 3014)
  • Defendants: Philips RS North America LLC, Koninklijke Philips N.V. and related Philips entities
  • Court and docket number, when available: U.S. District Court for the Western District of Pennsylvania, MDL No. 3014, Case No. 2:21-mc-01230 (Hon. Joy Flowers Conti)
  • MDL number, judge, and case count, when an MDL exists: MDL No. 3014, Hon. Joy Flowers Conti presiding, established October 8, 2021; case count not published on the docket
  • Filing date: MDL 3014 established October 8, 2021 (JPML Transfer Order, Doc. No. 1)
  • Main allegations: PE-PUR foam degraded and exposed users to inhaled/ingested particulates and chemicals linked to respiratory harm and cancer risk
  • Products or people involved: REMStar SE Auto and other recalled Philips Respironics CPAP, BiPAP and ventilator models; people who used those devices

Latest REMStar SE Auto CPAP Lawsuit Updates

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

The U.S. District Court for the Western District of Pennsylvania named lead counsel for plaintiffs still pursuing claims. Their cases were not resolved by the 2024 settlements. This keeps the case organized for owners of a recalled device, including REMStar SE Auto, who still have not yet settled their own claim.

June 26, 2026: MDL Court Dismisses Claims of 43 Non-Compliant Plaintiffs

The same court dismissed the claims of 43 plaintiffs who had not answered a court order requiring case information by a set deadline. The dismissal did not touch the personal-injury and economic-loss settlements from 2024, whose registered claimants had already received their payment.

April 15, 2026: Philips Issues a Remediation Progress Update

Philips issued a remediation progress update on its recall repair-and-replacement program [1]. It reported sleep-therapy device fixes were almost complete. Ventilator repairs and replacements were still ongoing. Philips said it remained subject to the 2024 consent decree’s sales limits in the United States.

March 7, 2026: Canadian Settlement Claims Period Closes

The deadline passed to submit a claim in the Canadian Philips CPAP class-action settlement [2]. The administrator began reviewing claims that were filed. Payments for approved claims started in May 2026. Philips sends them out by e-transfer or by cheque to Canadian claimants whose device was recalled.

January 31, 2025: U.S. Personal-Injury Settlement Becomes Final

The personal-injury settlement became final, since registrations from eligible claimants had passed 95 percent of the court’s target by the set deadline. Payment to those registered claimants went out in the first half of 2025. People who missed the deadline could not join that fund afterward.

December 5, 2024: Medical-Monitoring Settlement Gets Final Approval

A separate court order also finalized the medical-monitoring class settlement and awarded attorneys’ fees to class counsel that same day. The $25 million fund instead funds ongoing research into the recalled devices’ possible health effects, rather than paying individual class members directly.

June 21, 2024: Amended Deadline Passes to Join the Personal-Injury Settlement

The amended deadline passed for eligible claimants to submit an Identification Order Declaration and join the settlement program. A June 7, 2024 order moved it from the original June 10, 2024 date to June 21, 2024. Anyone who missed that date could not register without agreement from the company and plaintiffs’ lawyers. The wider case stayed active for other claims.

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

Philips Respironics agreed to pay $1.075 billion to resolve personal-injury claims. That included a $1.050 billion fund plus $25 million in costs. The company agreed the same day to a separate $25 million medical-monitoring settlement. That fund covers research into the recalled devices’ effects on users.

April 25, 2024: Economic-Loss Settlement Receives Final Court Approval

The court gave final approval to the economic-loss class settlement and entered final judgment [3]. This closed the case for those claims. The settlement pays device users and payers such as insurers through two separate funds. Potential Compensation below gives the exact amounts. A federal court entered a consent decree against Philips Respironics. The decree limits new device sales at listed Pennsylvania and California facilities. The FDA required proof that manufacturing rules were met before sales could resume, and the recall’s repair and refund plan had to be finished [4].

March 10, 2022: FDA Orders Philips to Notify Patients Directly

The FDA ordered Philips Respironics to notify patients directly about the recall, instead of relying only on distributor and provider notice. The agency kept closely tracking the foam problem across the recalled models, including REMStar SE Auto and its sibling devices.

October 8, 2021: JPML Consolidates Federal Lawsuits into MDL 3014

The Judicial Panel on Multidistrict Litigation (JPML) combined the federal Philips Respironics lawsuits into one case, MDL No. 3014, for shared handling. Judge Joy Flowers Conti took charge of the case in the Western District of Pennsylvania. That order later led to the funded settlements. Philips Respironics recalled REMStar SE Auto and related devices under FDA Recall Number Z-1974-2021 [5]. It found the PE-PUR sound-abatement foam inside them could break down. Philips recalled the same device families outside the United States around the same time. This recall became the basis for the litigation described above.

What Is PE-PUR Foam?

According to guidance from the American Academy of Sleep Medicine, PE-PUR (polyester-based polyurethane) foam is the sound-abatement material inside REMStar SE Auto and other Philips Respironics devices, used to cut noise and vibration [6]. Under hot, humid conditions the foam can break down into small pieces. Black debris or certain chemicals can then enter the device’s air pathway and be inhaled or swallowed. That breakdown led to the 2021 recall and this page’s litigation.

Who May Be Affected?

Anyone who used a recalled Philips Respironics device before its foam issue was fixed may have been exposed to PE-PUR particulates or chemical emissions. The FDA recall notice names REMStar SE Auto specifically among the recalled models. It does not separately list a plain REMStar SE model without “Auto” in the name. People who used REMStar SE Auto, SystemOne, DreamStation, Dorma 400 or 500, or another recalled model, and who filed an Identification Order Declaration by June 21, 2024, may be part of the funded personal-injury settlement described under Potential Compensation. People who used a recalled device but did not register by that date, or whose diagnosis came later, are not covered by that settlement. Other options take an individual legal review.
Think you may qualify?
Schmidt & Clark offers a free, no-obligation case review for people who used a recalled Philips Respironics device such as REMStar SE Auto and were later diagnosed with a qualifying illness. A case review does not promise eligibility for any settlement or program, or any particular result. Start My Free Case Review

Reported Injuries or Damages

The FDA describes possible harms from the foam issue as irritation of the skin, eyes or respiratory tract, inflammation, headache, asthma, and hypersensitivity reactions. It also lists nausea, vomiting, and effects on other organs including the kidneys and liver, with possible toxic and carcinogenic effects. Reports name this device family, including REMStar SE Auto. Lawsuits and the personal-injury settlement allege some of these exposures caused cancer or other injuries. This allegation applies to people who relied on a recalled device for sleep or respiratory therapy. Philips Respironics points to thirteen third-party epidemiological studies. All of them found no consistent statistical association between PAP device use, including its own devices, and cancer risk in patients with obstructive sleep apnea.

Recall and Regulatory Background

The June 14, 2021 recall (see Latest Updates above) carried an FDA Class I classification, the agency’s most serious type, used when a device could cause serious injury or death. Health Canada recalled the same device families on June 23, 2021 [7]. A federal court’s 2024 consent decree now limits new device sales until Philips Respironics meets FDA rules. See the Philips Respironics recall page for full detail.

Evidence to Preserve

Anyone who used a recalled REMStar SE Auto or related device and believes they were harmed should keep the following records and information:
  • The device’s registration confirmation and serial number from the Philips recall website
  • Purchase, lease or insurance records showing when the device was used
  • Medical records showing the diagnosis, its date, and any treatment received
  • Communications with Philips Respironics, a durable medical equipment provider or a physician about the device
  • Photographs of the device and any visible foam debris or discoloration
  • Notes on the dates and length of time the device was used
These records can help show when a recalled device was used and connect that use to a later diagnosis, which matters both for the funded settlements and for any other claim outside them.

Filing Deadlines

Deadlines for a product-liability or personal-injury claim come from state law. They do not come from the recall or the settlement calendar. How much time someone has depends on where they live and when the exposure, illness or diagnosis happened. Some states start the clock at diagnosis rather than first use. Missing the applicable deadline can end a claim even when the facts are strong, so checking with a lawyer promptly is the best way to find out which deadline applies.

Potential Compensation

Philips Respironics’ funded settlements pay out in several categories. The $1.075 billion settlement pays eligible, registered claimants through a court-approved process rather than a fixed amount per person. The economic-loss settlement pays $445 million to a fund for device users and $34 million to a fund for payers such as insurers. A separate $25 million medical-monitoring fund pays for research, rather than paying class members directly. Compensation amounts vary by case. Past results do not guarantee future outcomes. Because every claim differs, only a lawyer’s review can weigh the potential compensation categories that may apply.

Frequently Asked Questions

Can I Still File a Philips CPAP Lawsuit?

Yes, you can still file a Philips CPAP lawsuit as an individual claim, since the MDL remains open to new and non-settling plaintiffs. Whether you can proceed depends on your state’s filing deadline, so an attorney should confirm it before you decide.

How Many Devices Did the Philips Respironics Recall Cover?

The Philips Respironics recall covered about 15.4 million devices worldwide, including roughly 10.3 million in the United States and 5 million elsewhere. That total spans REMStar SE Auto and the other recalled device families together. The consent decree does not stop Philips from selling all CPAP machines. It limits new-device sales at the facilities named in the decree until Philips meets FDA rules, while servicing of devices already with patients and providers continues.

What Did the 2022 Palm Study Find About PAP Device Use?

The 2022 Palm study, published in the European Respiratory Journal, found patients using polyurethane-foam PAP devices were prescribed respiratory relief medication somewhat more often. It found no statistical difference in hospitalization outcomes tied to device type.

Are There Philips CPAP Lawsuits Outside the United States?

Yes, Philips Respironics faces related consumer class actions outside the United States. Beyond the Canadian settlement, Philips reports pending litigation in Australia and Israel, and collective or individual actions in several European countries.

What Other Philips Respironics Devices Were Recalled with REMStar SE Auto?

Other Philips Respironics devices recalled with REMStar SE Auto include SystemOne, DreamStation, DreamStation Go, Dorma 400 and Dorma 500, all under the same FDA notice. A-Series BiPAP, Trilogy and OmniLab Advanced+ models were part of that same June 2021 recall action as well.

How Do I Register a Recalled REMStar SE Auto Device?

Register a recalled REMStar SE Auto device online at Philips’ recall website, or call 1-877-907-7508 if you cannot go online. The process asks for the device serial number so Philips can confirm its recall and settlement status.

References

  1. https://www.philips.com/a-w/about/investor-relations/recall-sleep-and-respiratory.html
  2. https://cpapsettlement.kpmg.ca/
  3. https://www.pawd.uscourts.gov/sites/pawd/files/3014_Settlement.pdf
  4. https://www.fda.gov/medical-devices/respiratory-devices/recalled-philips-ventilators-bipap-machines-and-cpap-machines
  5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=187815
  6. https://aasm.org/clinical-resources/guidance-philips-recall-pap-devices/
  7. https://recalls-rappels.canada.ca/en/alert-recall/philips-respironics-recalls-several-models-cpap-and-bilevel-pap-machines-and