Philips Respironics ventilator, BiPAP and CPAP recall over degrading sound-abatement foam

Incident

Philips Respironics ventilator, BiPAP and CPAP recall over degrading sound-abatement foam

30 June 2021Worldwide (about 15 million devices); USTier 0: automation stayed upDevices

Philips recalled about 15 million breathing devices because PE-PUR foam could degrade into particles and chemicals the patient could inhale; remediation ran years and ended in a consent decree.

Sources checked when written 26 September 2026

TierNo loss of automation is documented. How tiers are assigned.

What happened

On 30 June 2021 Philips Respironics recalled certain ventilators, BiPAP and CPAP machines (Class I) because the polyester-based polyurethane foam used to reduce noise could break down, releasing particles or invisible chemicals into the air path. FDA issued a section 518(a) order in March 2022 over the adequacy of recall notifications. By 31 January 2024 FDA had received more than 116,000 MDRs, including 561 death reports, associated with foam breakdown; FDA notes MDRs cannot by themselves establish cause. On 9 April 2024 a federal court entered a consent decree restricting new device production at three Philips facilities until compliance, requiring a recall remediation plan and independent review of testing of the replacement silicone foam. Separately, in July 2024 a Class I software correction for Trilogy Evo ventilators addressed issues including an inaccurate display of delivered oxygen.^[1,2,3,4]

Documented harm

561 death reports and over 116,000 MDRs associated with foam breakdown as of Jan 2024; causation not established by MDRs alone.

What it teaches

A hazard can sit inside a working device for years with no alarm or visible symptom.
Recall execution (replacement supply, notification, patient tracing) is a failure point of its own.
Home-use life-support devices need a registry the hospital or DME supplier can query when a recall lands.

Sources

FDA Activities Related to Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines. U.S. Food and Drug Administration, November 2024. Primary Official report · link checked 2026-09-26
Problems Reported with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines. U.S. Food and Drug Administration, 31 January 2024. Primary Dataset · link checked 2026-09-26
Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines. U.S. Food and Drug Administration, 9 April 2024. Primary Official report · link checked 2026-09-26
Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal. U.S. Food and Drug Administration, 16 July 2024. Primary Official report · link checked 2026-09-26

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