This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

Product Description	Model Number	UDI-DI
DreamStation Auto CPAP	UDSX500S11F	00606959423314
DreamStation Auto BiPAP	UDSX700S11F	00606959423338
DreamStation Auto CPAP	UFRX500S14	00606959455045

What to Do

On June 6, 2025, Philips Respironics sent all affected customers an Urgent Medical Device Recall Letter recommending the following actions:

Continue using the device until a replacement is delivered.
Contact Philips at 1-877-387-3311 or PatientSupport@philips.com if you received the letter but have not been contacted.
Return affected devices using the included instructions and prepaid label when the replacement arrives.
Be aware that Philips is calling affected patients and suppliers and sending replacement devices with return instructions.

Reason for Recall

Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programming error introduced during rework by a supplier, which may result in incorrect therapy modes (e.g., BiPAP configured as CPAP), limited pressure, unavailable features, or improper sensor/humidifier function.

Use of the affected devices may cause serious health consequences including hypoventilation, disrupted sleep, skin or airway burns, and ineffective treatment of sleep apnea, which could worsen comorbidities.

There have been three reported injuries and no reports of death.

Device Use

These non-continuous ventilators are used nightly at home or in clinical settings to treat obstructive sleep apnea. The affected devices were reworked as part of an earlier foam-related remediation effort and may have been incorrectly configured before distribution.

Contact Information

Customers in the U.S. with questions about this recall should contact Philips Respironics at 1-877-387-3311 or PatientSupport@philips.com.

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.