The Philips Respironics recall is the largest PAP recall US patients have dealt with. The FDA says it affected 15 million devices worldwide (FDA). Five years on, it still shapes what US buyers can get, because a 2024 court order limits Philips’ ability to sell new machines. This guide summarizes the FDA’s published information. The FDA’s pages are the authority, so check them for updates.
What was recalled and why
In June 2021, Philips recalled certain ventilators, BiPAP machines and CPAP machines because the polyester-based polyurethane (PE-PUR) foam used to reduce sound and vibration can break down. If it does, “black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.” The FDA says breakdown may be caused by hot and humid conditions and worsened by ozone cleaners or other cleaning methods the manufacturer doesn’t recommend (FDA).
Affected devices (made 2009 – April 26, 2021)
Per the FDA’s recall page:
| Sleep therapy (CPAP / BiPAP) | Ventilators and other |
|---|---|
| DreamStation | A-Series BiPAP A40 (ventilator) |
| DreamStation Go | A-Series BiPAP V30 Auto (ventilator) |
| DreamStation ASV | C-Series ASV (ventilator) |
| DreamStation ST, AVAPS | Garbin Plus, Aeris, LifeVent (ventilator) |
| SystemOne (Q-Series) | Trilogy 100 and Trilogy 200 (ventilator) |
| SystemOne ASV4 | OmniLab Advanced+ |
| REMstar SE Auto | Certain Trilogy Evo units distributed Apr 15 – May 24, 2021 |
| A-Series BiPAP A30, BiPAP Hybrid A30 | |
| C-Series S/T and AVAPS | |
| Dorma 400, Dorma 500, E30 |
The health risks the FDA lists
The FDA’s recommendations page lists the potential risks of inhaling or swallowing foam pieces: irritation of the skin, eyes, nose and airway, inflammatory response, headache, asthma, and toxic or cancer-causing effects. For chemicals released from the foam, it lists headache, dizziness, irritation, hypersensitivity reactions, nausea or vomiting, and toxic and cancer-causing effects.
What to do if you own a recalled device
From the FDA’s recommendations:
- Talk to your health care provider before changing anything. The FDA says that “for some patients, stopping use of the recalled device may involve greater risk than continuing its use”. With your provider you may decide to stop, switch to a device that isn’t recalled, keep using it, or try other sleep apnea treatments.
- Find the serial number and register. Register on Philips’ recall website, or call Philips at 877-907-7508 (press 2 for Spanish). If your model isn’t on the list, your DME supplier can check whether your device was recalled.
- Keep your confirmation number. Keep it with the serial number. Philips asks for both, and you can check status on the Philips patient portal.
- Expect a remedy notice. Under the consent decree’s Recall Remediation Plan, registered owners receive notice of their options: a repaired device, a replacement, or for certain devices a partial refund.
- Report problems to the FDA through the MedWatch Voluntary Reporting Form.
Cleaning and filters: the FDA’s do-nots
- Don’t use ozone or UV light cleaners. The FDA says ozone cleaners may worsen foam breakdown even when you can’t see foam pieces.
- Don’t add a filter to a CPAP or BiPAP. A filter may change how the device works and won’t reduce contact with chemicals from the foam. (Ventilator users get separate guidance: talk to your provider about an inline bacterial filter.)
- Don’t try to remove the foam yourself. It may damage the device or release more foam and chemicals.
If you got a repaired or replacement unit
The FDA says to keep using your repaired or replaced device and talk to your provider if you have concerns. It notes that one silicone-based foam used in a similar device marketed outside the US failed a test for volatile organic compounds. Testing Philips provided on US-authorized devices showed acceptable results, and the FDA asked for independent laboratory testing (FDA).
The April 2024 consent decree
On April 9, 2024, a federal court entered a consent decree against Philips Respironics (FDA press release). According to the FDA, it:
- restricts, with limited exceptions, production and sale of new CPAP, BiPAP and other devices at several Philips Respironics facilities in Pennsylvania and California until certain requirements are met;
- requires Philips to receive written notice from the FDA that it complies before resuming those operations;
- lets Philips keep making and distributing certain devices the FDA determined to be “medically necessary”, plus replacement parts and accessories for devices people already have;
- requires a Recall Remediation Plan (repair, replacement, or for some devices a partial refund);
- generally bars exporting recall-remediation CPAP and BiPAP devices for commercial sale until US patients have been prioritized; and
- requires independent testing of the replacement silicone-based foam.
In the same release, the FDA said it believes “there is adequate supply and that alternative manufacturers are able to handle patient demand for CPAP and BiPAP machines.”
What this means if you are buying now
If you need a new CPAP or BiPAP in the US, assume a new Philips sleep-therapy device won’t be offered until the FDA’s position changes. Check the FDA pages for updates. HHZ’s US CPAP buyer’s guide covers current alternatives. If you’re on Medicare, the CPAP coverage guide explains replacement rules.
Verdict
If you still use a recalled Philips device, don’t stop on your own. Talk to your provider, register the serial number with Philips, and follow the FDA’s do-nots on ozone and UV cleaners, filters and foam removal. If you’re buying new, plan around a different manufacturer, and recheck the FDA’s recall page before you decide, since the consent decree’s restrictions last until the FDA confirms compliance.