Voluntary Recall Information

Philips Respironics Sleep and Respiratory Care devices


In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only).

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Globally, we have produced over 98% of new devices and repair kits required for replacement of affected devices*

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Approximately 2,800,000 new devices and repair kits produced to meet the U.S. registration demand*

Approximately 2,300,000 devices remediated and in the hands of U.S. patients and Durable Medical Equipment providers (DMEs)**

* As of May 4, 2023

** A remediated device includes new, recertified, alternative devices sent as replacements for affected units, devices shipped to DMEs who are directly handling patient remediations, and financial payment. Repair kits are utilized in the rework process to create a recertified unit. To learn more, click here

News and updates    

May 2023 update on completed testing for home sleep therapy devices shows no appreciable harm to patients


The tests, conducted together with five independent, certified testing laboratories and assessed by third- party qualified experts and Philips Respironics, as well as an external panel of experts, have now been completed and risk assessments evaluated for all home sleep therapy devices.

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