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CPAP Recalls: What You Need to Know
- Philips Respironics voluntarily recalled many CPAP, BiPAP, and ventilator devices in 2021, then stopped selling nearly all of their PAP and ventilator devices in the U.S. in 2024 as the result of an agreement with the U.S. government.
- Machines were recalled because of faulty foam that could break off in small pieces and be breathed in by sleepers. The foam was present in millions of machines made between 2009 and 2021.
- In 2023 and 2024, Philips settled class-action lawsuits related to the recall for $479 million and $1.1 billion, respectively.
- Although Philips took down their online U.S. Patient Portal in January 2026 after remediating 99% of registered recalled devices, you can still return a recalled device to Philips and receive remediation if you have one.
In June 2021, Philips Respironics initiated a voluntary CPAP machine recall that affected 15 million CPAP devices around the world. This CPAP recall applied to nearly every CPAP machine the brand had manufactured in the prior decade, as well as most of their BiPAP and ventilator machines. The reason for the recall was faulty foam in the devices that could break down and be breathed in by sleepers, potentially causing injury or illness.
In the years following Philips’ voluntary recall, there have been investigations, government agreements, and class action lawsuits related to the devices that have resulted in major payouts by Philips and the discontinuation of Philips Respironics CPAP sales in the U.S. As of January 2026, Philips Respironics is continuing remediation efforts and still does not sell their devices in the U.S.
List of All Currently Recalled Devices
The following Philips Respironics CPAP machines, BiPAP machines, and ventilators manufactured prior to April 26, 2021, regardless of serial number, were part of the Philips Respironics recall and are no longer available for sale in the U.S.:
- A-Series BiPAP A30 (BiPAP Hybrid A30 Ventilator (A-Series)
- A-Series BiPAP A40
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto Ventilator (BiPAP V30 Auto Ventilator (A-Series)
- C-Series ASV
- C-Series S/T, AVAPS
- Dorma 400 auto-CPAP
- Dorma 400 CPAP
- Dorma 500 auto-CPAP
- Dorma 500 CPAP
- DreamStation 1
- DreamStation ASV
- DreamStation BiPAP autoSV
- DreamStation BiPAP AVAPS
- DreamStation BiPAP S/T
- DreamStation Go APAP
- DreamStation Go Auto-CPAP
- DreamStation Go CPAP
- DreamStation ST, AVAPS
- E30
- Garbin Plus, Aeris, LifeVent Ventilator
- OmniLab Advanced Plus
- REMstar SE Auto
- SystemOne 50 Series CPAP
- SystemOne 50 Series auto-CPAP
- SystemOne 50 Series BiPAP
- SystemOne ASV4 (System One BiPAP autoSV, System One BiPAP autoSV Advanced)
- System One BiPAP AVAPS (C-Series)
- System One BiPAP S/T (C-Series)
- SystemOne Q-Series
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
The recall also covers over 90,000 Trilogy Evo ventilators with certain serial numbers that were sold between March 20, 2019 and February 16, 2024, though not all Trilogy Evo ventilators were recalled.
Additional Devices Philips Stopped Selling in 2024
As part of an agreement Philips made with the U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA), called a consent decree, the company stopped selling all CPAP and BiPAP machines in the U.S., as well as the following sleep and respiratory care devices, beginning January 25, 2024:
- Alice 6
- Alice NightOne
- DreamStation Go
- EverFlo
- Millennium M10
- OmniLab Advanced +
- SimplyGo
- SimplyGo Mini
- Trilogy EVO
- Trilogy EV300
It is important to note that these devices have not been recalled, and Philips is still allowed to service them and sell related accessories and replacement parts.
Why Machines Are Being Recalled
Millions of Philips Respironics CPAP machines were recalled because they contained polyester-based polyurethane (PE-PUR) foam that could break down into small pieces and be breathed in by sleepers, potentially causing illness or injury. The intended purpose of the foam was to dampen sounds and vibrations made by the machine.
Since the 2021 recall, the FDA has received more than 116,000 medical device reports associated with recalled Philips Respironics machines. These reports document an array of respiratory symptoms, cancer, and 561 deaths potentially linked to Philips CPAP device use. Because of the risk of serious injury or death, it is considered a Class I recall.
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Philips CPAP Recall: Latest Updates
In January 2026, Philips updated their website to say they’d closed their U.S. Patient Portal, which was a webpage that allowed people to register their recalled devices and receive remediation. Philips also announced that they’ve remediated over 99% of the sleep therapy devices that were registered. That said, Philips continues to remediate recalled devices and is still accepting device returns.
Philips CPAP Machine Recall Timeline
Here’s a timeline of major events that have happened related to the Philips CPAP recall:
| June 2021: Voluntary Recall of Millions of CPAP and BiPAP Devices | Philips Respironics voluntarily recalled millions of CPAP, BiPAP, and ventilator devices containing faulty foam that could degrade and be breathed in by sleepers, potentially causing harm. |
| September 2023: Investigation of Philips’ Knowledge of the Problem | A journalistic investigation revealed that Philips Respironics had evidence that faulty foam in devices was harming sleepers more than a decade before issuing the recall. This revelation led to calls for accountability and the involvement of the Department of Justice (DOJ). |
| September 2023: Class Action Lawsuit Settlement for Economic Damages | In a class action lawsuit settlement, Philips agreed to pay $479 million in economic damages to users of recalled devices. This settlement only compensated for the costs incurred by individuals who used the recalled devices, not for related injuries, illnesses, or deaths. |
| November 2023: FDA Warning About DreamStation 2 | The FDA warned people to watch Philips DreamStation 2 CPAP machines for overheating after receiving reports of smoke, burning smells, and fire while using the machines. DreamStation 2 models are not recalled devices, but Philips used them to replace some recalled devices. |
| January 2024: Discontinuation of U.S. Philips Respironics Sales Due to DOJ and FDA Agreement | Philips Respironics, the DOJ, and the FDA reached an agreement about the recalled machines, called a consent decree. The DOJ and FDA required Philips Respironics to remediate the recalled devices, have their facilities inspected, pay money to the U.S. government, and stop selling CPAP and BiPAP machines in the U.S. until all requirements of the agreement are met. |
| April 2024: Class Action Lawsuit Settlement for Personal Injury | Philips announced an agreement to pay a $1.1 billion settlement in a class action lawsuit regarding claims of illness, injury, or death related to recalled devices. However, Philips did not admit fault or that the injuries were caused by their devices. |
| January 2026: Status Update from Philips | Philips announced on their website that they’ve successfully remediated over 99% of the registered recalled devices and closed their U.S. Patient Portal webpage. The company continues to finish remediation, and people who still have recalled devices are still able to return them. |
Concerns About Recalled Philips CPAP Machine Replacement Models
During the recall, Philips pledged to replace many devices, including CPAP machines, with newer models that use a different foam. However, the FDA has issued a warning that the new silicone foam used in the replacement CPAP and BiPAP machines may release “certain chemicals of concern,” including the carcinogen formaldehyde.
The FDA has also issued a warning to users of Philips DreamStation 2 CPAP machines, one of replacement models issued in the wake of the recall. Within a span of three months in 2023, the FDA received hundreds of reports of overheating, smoke, fire, and burns during device use. According to the FDA, electrical or mechanical malfunctions may be to blame.
These discoveries are still under investigation and, as of yet, have not resulted in additional recalls.
Possible Health Risks From Recalled CPAP Devices
If the foam degrades in a recalled Philips device and a sleeper breathes in its pieces or particles, they may experience these health risks:
- Asthma
- Sinus congestion or infection
- Chest pressure
- Coughing
- Sore throat
- Skin, nose, and eye irritation
- Dizziness
- Chronic headaches
- Nausea and vomiting
- Cancer of the sinuses, throat, esophagus, kidney, and liver
What to Do if You Own a Recalled CPAP Machine
If you currently use a recalled Philips Respironics CPAP or BiPAP machine, contact your doctor to discuss your next steps. Depending on your needs and circumstances, your doctor may recommend that you stop using your device or that you continue using it until you acquire a replacement.
If you want to receive remediation for a recalled Philips Respironics device, you can email the company at CPAPRecallClosure@philips.com with your name, phone number, mailing address, device serial number, and any questions. If Philips confirms that your device was part of the recall, they may ask you to return it and offer you a replacement model. They may also offer to repair the device or refund you for it.
Do not try to repair your recalled device on your own. Specifically, the FDA says you should not:
- Use ozone or ultraviolet (UV) light cleaners to disinfect your machine
- Attempt to remove the foam from your machine
- Try to alter your advice, for example, by using multiple filters at once
These actions may increase your risk of harm or decrease the effectiveness of your therapy.
Additionally, if you have health complaints that you suspect may be related to using a recalled PAP device, or if you have noticed any other problems with your device, you can file a report through the FDA’s MedWatch Voluntary Reporting Form.
What to Do if You’re a Healthcare Provider
If you’re a healthcare provider with patients who use recalled Philips CPAP devices, there are several steps that the American Academy of Sleep Medicine (AASM) recommends that you take.
- Provide cleaning instructions. Emphasize the importance of following the device-maker’s cleaning instructions to patients who plan to continue treatment with recalled equipment.
- Contact patients to whom you’ve prescribed or issued recalled devices. The AASM provides a sample script for informing patients about the recall and potential risks to their health.
- Discuss next steps with patients who use recalled devices. If possible, prescribe or issue a replacement device not affected by the recall. If circumstances prevent that from happening immediately, weigh the benefits and risks of temporarily continuing treatment with a recalled device.
- Encourage patients to email their device information to Philips. If Philips offers your patients replacement devices, discuss the potential risks they might face with newer Respironics models.
Frequently Asked Questions
Are repaired or replacement CPAP machines safe?
Two potential issues have been raised regarding the repaired CPAP machines and replacement CPAP machines Philips has used to remediate recalled machines. Both repaired and replacement devices may contain silicone-based foam, which the FDA noted has failed safety tests outside of the U.S.
Some DreamStation 2 replacement devices have been linked to overheating and burning issues, but they haven’t been recalled.
In response to the FDA’s concerns about silicone-based foam, Philips conducted testing and concluded that the new foam they’re using in devices is safe.
Philips submitted the results of their testing to the FDA, but the FDA has not yet commented on the safety of the silicone-based foam.
If you do not feel comfortable using a replacement device provided by Philips, talk to your doctor about your options.
I used a recalled Philips CPAP device — will my health be affected?
Not everyone who used a recalled Philips CPAP or BiPAP device had the foam degrade and break off into small pieces, which is what posed a health risk. The faulty foam was more likely to degrade if the machine had been exposed to high heat and humidity or had been cleaned using ozone CPAP cleaning devices, which are unauthorized.
Whether or not you experience negative health effects from using a recalled CPAP machine depends on a range of factors, including the state of the foam in your machine, how long you used your device, and your overall health status. If you are concerned about the health consequences of using a recalled machine, talk to your doctor.
Am I entitled to compensation for economic losses related to the Philips CPAP recall?
Philips’ 2023 economic damages settlement provided compensation to people who owned a recalled CPAP or BiPAP machine. The deadline for registering a claim as part of this settlement closed in August 2024, and payments were made until the end of 2025.
Am I entitled to compensation for personal injuries related to the Philips CPAP recall?
Philips’ 2024 personal injury settlement provided compensation to people who claimed they experienced illness or injury stemming from the use of a recalled Philips device. The deadline for registering a claim as part of this settlement closed in January 2025.
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Jay Vera Summer is a writer, editor, and wellness coach. She holds a Bachelor's of Science in psychology and Master's degrees in both writing and public policy.
Gerard J. Meskill, MD is board certified in both neurology and sleep medicine, and he is the founder and CEO of Tricoastal Narcolepsy and Sleep Disorders Center. The "Tricoastal" moniker references his background: he completed neurology residency on the East Coast at Long Island Jewish Medical Center – where he served as chief resident, sleep fellowship on the West Coast at Stanford University, and he now practices sleep medicine and neurology on the Gulf Coast in the greater Houston, Texas area.
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