Safety and recalls
Philips CPAP Recall: What Happened and What to Do Now (October 2026)
In June 2021 Philips Respironics recalled millions of CPAP, BiPAP and ventilator devices because sound reducing PE-PUR foam inside could break down. A 2024 consent decree stops Philips from selling new sleep and respiratory devices in the US until it meets FDA requirements. As of Philips' September 2026 update it reported completing all US remediation plan steps for sleep therapy devices, but if you still have an unremediated recalled device, contact Philips and talk to your clinician before stopping therapy.
What happened in 2021
On June 30, 2021 the FDA alerted users that Philips had recalled certain ventilators, BiPAP machines and CPAP machines because the polyester based polyurethane (PE-PUR) sound abatement foam could break down, with potential for users to inhale or swallow foam particles or chemicals. The FDA classified it as a Class I recall, its most serious category, in July 2021.
Affected sleep devices included the original DreamStation, SystemOne and DreamStation Go families, among others. The DreamStation 2 was not part of the foam recall.
The 2024 consent decree
Philips announced agreement on a proposed consent decree with the US Department of Justice and FDA on January 29, 2024, and a federal court entered it on April 9, 2024, according to the FDA. Under it, Philips Respironics will not sell new CPAP or BiPAP machines or other new respiratory care devices in the US until the decree's relevant requirements are met.
Philips can keep servicing devices already in use and can keep selling accessories (including masks), consumables and replacement parts in the US. Sales outside the US continue. As of October 2026 we found no announcement that Philips has resumed new sleep device sales in the US; check Philips' consent decree page for the current status.
Remediation status in 2026
Philips' recall progress page, updated September 10, 2026, says that as of July 6, 2026 it had completed all steps required by the US Recall Remediation Plan for sleep therapy devices, with 2.685 million US patients remediated against 2.685 million actionable registrations as of September 1, 2026.
Philips closed its US patient portal for recalled CPAPs and BiPAPs on January 1, 2026, according to Sleep Review, and says it will continue to accept returned affected devices at no cost and keep working on new and existing registrations. Philips describes complete test results for the DreamStation as positive and reassuring; testing on some ventilators continued.
A separate 2025 DreamStation recall
In June 2025 Philips recalled certain reworked DreamStation Auto CPAP and Auto BiPAP devices (models UDSX500S11F, UDSX700S11F and UFRX500S14) because a programming error introduced during rework could cause the wrong therapy mode, limited pressure or humidifier problems. The FDA reported three injuries and no deaths as of its September 2025 update.
Philips' letter told patients to keep using the device until a replacement arrives. Affected patients who have not been contacted can call Philips at 1-877-387-3311 or email PatientSupport@philips.com.
What owners should do now
If you still use an original DreamStation, SystemOne or DreamStation Go that was never replaced or reworked, contact Philips through its recall information pages and tell your clinician and supplier. Do not stop therapy without talking to your clinician; the FDA has noted that stopping a recalled device without an adequate alternative may carry significant risks.
Never clean any Philips device with ozone or UV cleaners; Philips says these are not approved methods and ozone may worsen foam breakdown in recalled devices. Report any problem to the FDA through MedWatch.
Frequently asked questions
Is the Philips CPAP recall over?
Philips said that as of July 6, 2026 it had completed all steps required by the US remediation plan for sleep therapy devices, but it still accepts returned affected devices. The consent decree restricting new US sales remained in place in the most recent Philips information we checked in October 2026.
Can I still use my Philips DreamStation?
If it is a remediated or replacement device, keep following your clinician's advice and any Philips or FDA notice for your model. If it is an unremediated recalled device, contact Philips and talk to your clinician before deciding; do not stop therapy without a plan.
Can I still buy Philips CPAP masks?
Yes. The consent decree allows Philips to keep selling accessories including masks, consumables and replacement parts in the US.
Was the DreamStation 2 recalled?
The DreamStation 2 was not part of the 2021 foam recall. Check FDA recall listings and Philips notices for your specific model and serial number, since other recalls have occurred.
Is Philips selling new CPAP machines in the US?
Not under the consent decree until its requirements are met. As of October 2026 we found no announcement that new US sales had resumed.
Sources
Last reviewed October 11, 2026. How we research · Report an error