The Philips CPAP Recall: What CPAP Users Should Know

What was recalled and why

In June 2021, Philips Respironics recalled certain CPAP, bilevel PAP and ventilator devices, including some DreamStation models. The concern was the polyester-based polyurethane (PE-PUR) foam used to reduce sound. Philips said the foam could break down into particles that might be inhaled or swallowed, and could release certain chemicals, particularly under conditions such as heat and humidity. Philips also said that ozone cleaning methods could make foam breakdown worse.

What happened next

Philips ran a remediation program to repair or replace affected devices. In April 2024, Philips Respironics entered a consent decree with the US government. Under the decree, Philips stopped selling new CPAP and BiPAP sleep therapy devices in the United States until it meets the decree's requirements, while it can continue to service existing devices and sell accessories and replacement parts. Check the FDA and Philips websites for the latest status, as this may change.

If you have a Philips device

• Check whether your device is affected using the serial number lookup on Philips's recall website, or ask your DME.
• Do not stop using your device without talking to your clinician. Stopping treatment has its own risks, and your clinician can help weigh options.
• If your device was remediated or replaced, keep records.
• Avoid ozone cleaning devices, which Philips and the FDA have cautioned against.
• Report problems with any medical device to the FDA's MedWatch program.

Masks with magnets: a separate issue

Separately from the foam recall, the FDA has issued safety communications about CPAP masks with magnetic clips (from several manufacturers, including Philips in 2022 and ResMed in 2024) because the magnets can interfere with certain implanted medical devices. If you or your partner has an implant, ask your provider about non-magnetic options.

Choosing equipment today

If you need a new machine, your DME and insurer will usually offer options that are currently available. Any FDA-cleared device from a reputable supplier, used as directed, is appropriate. The best machine is the one that fits your prescription and that you can use comfortably every night.