Respironics field action

On June 14, 2021, Royal Philips’ subsidiary, Philips Respironics, initiated a voluntary recall notification* for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the U.S. and several other markets is under way. Philips Respironics has also been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain Volatile Organic Compounds (VOCs). 

If you are a patient, business customer or a clinician,
please visit this page for more information.

Resolving the Respironics recall

Progress to date

Remediation of sleep therapy devices almost complete; ventilation ongoing

FDA feedback received on testing and analysis for sleep therapy devices1

Reached agreement to resolve economic loss, personal injury, and medical monitoring litigation in the US

Reached agreement with US government on a consent decree

Back to market outside the US; servicing US market under agreed conditions part of the consent decree

Priorities ahead

Finalize recall and testing


DoJ investigation, other legal proceedings

Demonstrate compliance with the regulatory requirements and restore Respironics business

1.  Following ongoing communications with the FDA, Philips Respironics has agreed to implement additional testing to supplement current test data on PE-PUR foam. The FDA stated that current testing is extensive and conducted with independent parties and expressed no concerns with its validity or objectivity. Philips Respironics is in discussions with the FDA on the details of further testing.

More information

For more information on the recall notification for customers, users and physicians, please click here.

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*    This is a recall notification for the US only, and a field safety notice for the rest of the world

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