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.

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

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.

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.

Customers in the U.S. with questions about this recall should contact Philips Respironics at 1-877-387-3311 or [email protected].

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.

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.