Philips Recalled 15 Million Breathing Machines in 2021 Because Their Sound-Dampening Foam Could Crumble Into the Air Patients Inhaled. An FDA Inspection Found the Company Had Been Aware of Degrading Foam Since 2015.
On 14 June 2021, Philips Respironics announced a recall of CPAP machines, BiPAP machines and ventilators, around 15 million devices worldwide. Most were sleep apnea machines, which blow air into the airway of a sleeping person so that it stays open through the night. The ventilators were for people who could not reliably breathe on their own.
The problem was a piece of polyester-based polyurethane foam fitted inside the machines to make them quieter. The foam could break down into particles that entered the air pathway and were inhaled or swallowed by the user, and it could off-gas chemicals. The component had been included so that people could sleep through the noise of the device keeping them alive.
The Email From 2015
The Food and Drug Administration inspected the company's plant in Murrysville, Pennsylvania, on and off from 26 August to 9 November 2021. The inspector's report, a Form 483, runs to 28 pages. It records that on or around 25 November 2015, Philips Respironics was aware that another Philips entity had introduced a preventative maintenance procedure for Trilogy ventilators in response to foam degradation complaints from the field. That procedure was applied in one country only, which ProPublica later identified as Japan. The report states that no investigation, health hazard evaluation, risk analysis or design review was performed or documented in Pennsylvania.
The inspector then listed at least fourteen instances, assessments and test reports, dated from April 2016 to January 2021, in which the company was aware of possible foam degradation or chemical emissions. A 2016 test on foam returned with ventilator complaints documented "base polymer cleavage and embrittlement." A December 2020 risk assessment stated that "cytotoxicity and positive genotoxicity results observed from degraded PE-PUR foam samples indicate a potential patient risk." The recall followed six months later.
The Reporting System
The FDA does not test every machine that leaves a factory. It relies on manufacturers to pass on the complaints they receive. In September 2023, ProPublica and the Pittsburgh Post-Gazette reported that Philips had withheld more than 3,700 such complaints from the agency over the eleven years before the recall, starting in 2010. Philips told the reporters that complaints about the foam had been limited, that they were assessed case by case, and that it became aware of the potential significance of the problem in early 2021.
Once the recall was public, the reports arrived at the FDA directly. By 30 September 2023 it had received more than 116,000 medical device reports associated with foam breakdown, including 561 reports of death. The agency notes that such reports do not establish that a device caused an event. Philips said it had found no conclusive data linking the devices to the deaths, and that its own testing showed exposure was unlikely to result in appreciable harm to health. In October 2023 the FDA said that testing was not adequate to fully evaluate the risk.
The Replacements
Philips repaired and replaced the recalled machines using a silicone-based foam. In November 2021 the FDA disclosed that this silicone foam, as used in a similar device sold outside the United States, had failed a safety test for the release of volatile organic compounds, and asked for independent testing. In December 2023 ProPublica reported that laboratories retained by Philips had found formaldehyde coming from the silicone foam as well. Philips said the repaired and replacement devices were safe.
The repair work had its own problems. In February 2023 the company recalled 1,088 reworked DreamStation machines that had been given incorrect or duplicate serial numbers during reprogramming, which meant they could deliver therapy on the wrong prescription or not at all. The FDA classed it as a Class I recall, the most serious kind, on top of the Class I recall it was meant to fix.
The Settlement
In September 2023 Philips agreed to pay at least $479 million to settle claims from people and insurers who had paid for the machines. In April 2024 it agreed to pay $1.1 billion to resolve personal injury and medical monitoring claims covering about 58,000 people. Neither agreement included an admission of fault.
On 9 April 2024 a federal court in Pennsylvania entered a consent decree. The defendants included the chief executive of Royal Philips. Philips Respironics may not sell new CPAP or BiPAP machines in the United States until it meets the decree's requirements, which include remediating the recalled devices and hiring an independent expert to test the silicone foam. In March 2026 the company was allowed to sell one BiPAP model in the US for patients weighing between 40 and 66 pounds, to customers able to meet traceability requirements. The broader ban on sales remains in place.
The foam was installed to keep the machines quiet, and it worked. The complaints about it stayed quiet too, in the one place they were required to be sent, for about as long as the foam took to fall apart.
Filed from public reporting:
- U.S. Food and Drug Administration — "Form FDA 483: Philips Respironics, Inc., Murrysville, PA, Inspection 8/26/2021–11/9/2021"
- ProPublica — "Philips Kept Complaints About Dangerous Breathing Machines Secret While Company Profits Soared"
- U.S. Food and Drug Administration — "Problems Reported with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines"
- ProPublica — "Philips Recalled Breathing Machines in 2021. Chemicals of 'Concern' Found in Replacement Machines Raised New Alarm."
- U.S. Food and Drug Administration — "Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy"
- U.S. Food and Drug Administration — "Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines"
- CNN — "Philips reaches $1.1 billion settlement for CPAP machine lawsuits, admits no fault or liability"
- HME Business — "Philips to Sell DreamStation BiPAP for Low-Weight OSA Patients in US"
