Published March 2026

Philips Knew About the Foam Problem Since 2015 — Internal Documents Prove It

The June 2021 Philips CPAP recall looked, from the outside, like a company responding responsibly to a newly discovered problem. The inside view is considerably darker. Documents produced in litigation and regulatory investigations suggest Philips had credible evidence of foam degradation problems years before the recall — and chose not to act.

The Timeline the Public Wasn't Told

The recall was announced June 14, 2021. But the internal history is much longer than that announcement suggests.

Customers began reporting black particles in their CPAP devices — visible evidence of foam degradation — years before 2021. Some of these reports went to Philips directly through customer service. Some were filed as medical device reports with the FDA through the mandatory reporting process that device manufacturers are required to follow. The accumulation of these reports, visible in the FDA's publicly accessible MAUDE (Manufacturer and User Facility Device Experience) database, tells a story of a problem that was documented long before it was addressed.

In litigation, internal Philips documents have been produced showing that the company was aware of foam degradation concerns by at least 2015. The documents — described in court filings and reported by journalists covering the litigation — indicate that engineers within Philips identified the potential for PE-PUR foam degradation and the associated risk of chemical release into the airway. The decision-making process that followed, and why it took six more years for a recall to be issued, is at the center of the litigation.

What "Knowing" Means Legally

In product liability law, the concept of what a manufacturer "knew" is nuanced but important. A company doesn't have to have a smoking-gun memo that says "this product causes cancer" to be held liable. What matters is whether the company had information — complaints, test results, engineering analysis — that a reasonable, responsible manufacturer would have acted upon.

Philips received customer reports of black particles in their devices. Black particles are visible evidence that the foam is degrading — they're the physical remnant of the degradation process. A company that receives customer reports of black particles in an airway device has an obligation to investigate and, if investigation confirms a safety problem, to act. The evidence in this litigation suggests Philips had the information and didn't act for years.

The FDA Investigation

The FDA's investigation of the Philips recall was extensive and ultimately damning. In April 2022, the FDA issued a warning letter to Philips — one of the most serious regulatory actions the agency takes — for violating quality system regulations and failing to timely report device malfunctions. The warning letter documented multiple violations in Philips' manufacturing and complaint handling processes.

The FDA's investigation found that Philips had received thousands of complaints related to foam degradation and had not properly analyzed those complaints to determine whether they constituted reportable events under federal law. The failure to report these malfunctions to the FDA was itself a regulatory violation — it deprived both the FDA and the public of information they needed to make informed decisions about device safety.

In 2023, the FDA went further, publicly stating that Philips' remediation efforts — providing replacement devices and cleaning instructions — were insufficient to address the risks. The agency found that the replacement devices Philips was distributing also contained the same type of foam, raising questions about whether the "fix" was actually fixing anything.

The Department of Justice Action

In December 2024, Philips Respironics entered into a consent decree with the United States Department of Justice and the FDA, agreeing to extensive corrective actions and oversight. While not a criminal prosecution, the consent decree represented a formal government acknowledgment of significant regulatory violations at Philips. The company also paid substantial civil penalties.

This government action matters for civil litigants because it establishes, through a formal legal process, that Philips violated federal device regulations. In civil litigation, government findings of regulatory violations can be introduced as evidence to support the argument that the company acted negligently or recklessly in its handling of the foam safety issue.

The Years in Between

Between 2015 — when internal evidence suggests Philips first became aware of the foam issue — and 2021 — when the recall was announced — millions of devices were sold. Millions of patients used those devices every night, trusting that a regulated medical device used as directed was safe. Some of those patients have since developed cancers and other serious conditions. For those patients, the six-year gap between awareness and action represents six years of preventable exposure.

The lawsuits filed by Philips CPAP users are not just about compensation — though compensation for real medical harm is appropriate and important. They're also about accountability: making clear that a company cannot sit on safety information about a medical device, allow continued sales and use of a dangerous product, and face no consequences for that choice.