On April 10, 2024 Philips Respironics shared an update on how the company is moving forward in the wake of the June 2021 recall of millions of sleep and respiratory care devices in the United States, including their popular DreamStation CPAP machines. Philips Respironics announced that they have agreed to a consent decree with the Department of Justice which will prevent Philips Respironics from selling CPAP machines in the United States in the short term, but which "provides a clear path forward for Philips Respironics to take specific actions with defined milestones and deliverables to demonstrate compliance with the relevant FDA regulatory requirements." Here's the letter in full:

To Philips Respironics US Customers:

On April 9, 2024, the consent decree agreed to by Philips Respironics and the US Department of Justice (DOJ), representing the US Food and Drug Administration (FDA) went into effect. The consent decree provides a clear path forward for Philips Respironics to take specific actions with defined milestones and deliverables to demonstrate compliance with the relevant FDA regulatory requirements.

Impact of the consent decree in the US

In the US, Philips Respironics will continue to service sleep and respiratory care devices already with healthcare providers and patients, and supply masks and other accessories, consumables and replacement parts. Until agreed with the FDA, Philips Respironics will not resume selling new CPAP or BiPAP sleep therapy devices or other respiratory care devices. Our intention is to return to serving healthcare providers and patients in the US with sleep therapy devices once the relevant requirements of the consent decree have been met.

Our business outside of the US

Outside the US, Philips Respironics will continue to provide sleep and respiratory care devices, masks and other accessories, consumables, and replacement parts, subject to certain requirements.

Update on remediation efforts

We will continue to prioritize the completion of the Philips Respironics June 2021 recall. More than 99% of the actionable registered CPAP and BiPAP sleep therapy devices have been remediated globally, while the remediation of mechanical ventilators is ongoing in coordination with the relevant competent authorities.

Our strategic focus

Philips remains committed to the Sleep & Respiratory Care business and to meeting the requirements of the consent decree. We will further strengthen our quality system and processes, with a continued emphasis on providing products that patients and caregivers can trust. We acknowledge the challenges of the last few years, and are fully committed to restoring the trust of our customers, and continuing to serve the millions of patients who rely on our devices every day.

If you have questions related to the consent decree, please visit Philips.com/consentdecree.

Thank you for your continued support.


Daniel V. Leonard

Business Leader

Sleep & Respiratory Care

Philips Respironics

On June 14 2021, Philips Respironics announced a recall of several millions sleep and respiratory care devices, including System One REMstar and DreamStation CPAP machines. The recall was due to the presence of toxic and carcinogenic sound abatement foam installed on the inside of these devices. There are two critical problems with the polyurethane-based foam: 1) the emission of VOCs (volatile organic compounds) can be harmful to the user, and 2) the foam material can break down over time, and the machine can blow toxic foam particles into the user's device interface (e.g. a CPAP mask), causing the user to inhale and/or ingest the toxic foam particles. This scenario can potentially lead to health complications including cancer. Since announcing the recall Philips Respironics has remediated millions of devices. As the details of the consent decree dictate, these replacement machines - both DreamStation and DreamStation 2 machines - cannot currently be sold in the United States, at least for now, and at least until the FDA is satisfied that Philips Respironics has met all of the requirements of the consent decree.

If you have any questions about the Philips Respironics recall, or if you need information about replacing your existing CPAP machine, feel free to call us at 1-888-955-2727.

Andrew Senske
President / Co-Founder

CPAP-Supply.com is a leading online retailer of CPAP equipment. Located in Spokane, WA CPAP-Supply.com has been serving thousands of customers around the world since 2001. Founded on a belief that patients are their own best primary care providers, CPAP-Supply.com understands the importance of educating patients and customers on both the effects of and treatment for obstructive sleep apnea. For more information visit CPAP-Supply.com or call toll free 1-888-955-2727.

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