Philips Respironics Recall Affected 15 Million CPAP, BiPAP and Ventilator Devices Worldwide

Summary

Philips Respironics recalled millions of CPAP, BiPAP and ventilator devices beginning in June 2021 after identifying potential health risks associated with polyester-based polyurethane (PE-PUR) foam used to reduce sound and vibration inside the machines. The FDA says the recall ultimately affected approximately 15 million devices worldwide. The foam could break down into particles or release chemicals that could potentially be inhaled or swallowed by patients. The FDA classified affected recalls as Class I, its most serious recall classification. FDA – Philips recall and enforcement history: https://www.fda.gov/medical-devices/recalled-philips-ventilators-bipap-machines-and-cpap-machines/fda-activities-related-recalled-philips-ventilators-bipap-machines-and-cpap-machines Regulatory problems continued after the recall. In April 2024, the U.S. government alleged that Philips Respironics manufactured and distributed adulterated and misbranded medical devices and failed to comply with manufacturing requirements intended to ensure device safety and effectiveness. A federal court entered a consent decree of permanent injunction on April 9, 2024. With limited exceptions, it restricted Philips from manufacturing and selling new CPAP, BiPAP and other respiratory devices at several U.S. facilities until specified regulatory requirements were satisfied. Philips was also required to implement an FDA-approved recall remediation plan and undergo independent compliance oversight. U.S. Department of Justice – consent decree: https://www.justice.gov/archives/opa/pr/court-enjoins-philips-respironics-manufacturing-and-distributing-adulterated-and-misbranded Company response: Philips agreed to the consent decree but did not admit the allegations in the government's complaint. Philips described the decree as a roadmap for demonstrating regulatory compliance and restoring its Respironics business. Key facts: Approximately 15 million devices were affected worldwide; the recall began in June 2021 over potential PE-PUR foam health risks; the FDA classified affected recalls as Class I; and a federal court imposed a permanent-injunction consent decree in April 2024 restricting production and sales until compliance requirements were met.