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# Philips BiPAP, CPAP Mask Recall is Class 1: FDA
- URL: https://www.fdaweb.com/philips-bipap-cpap-mask-recall-is-class-1-fda/
- Published: 2023-02-02T12:00:00.000Z
- Updated: 2026-09-14T18:14:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153684

FDA says the Philips Respironics 8/2/22 recall of certain BiPAP and CPAP masks was Class 1\. An agency [statement](https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-masks-bipap-cpap-machines-due-safety-issue-magnets-may-affect?ref=fdaweb.com) says the company recalled some 18,670,643 units that were distributed in the U.S. between 1/1/15 and 9/9/22.

The notice says the company recalled the affected masks “due to a serious safety concern.” The masks have magnetic headgear clips to hold them in place, it says. The magnets can potentially cause injury or death if people who use them, or people near a person using a recalled mask, have certain implanted medical devices or metallic objects in the body.

The agency says that as of 9/9/22 there have been 43 complaints, 14 of which were serious injuries, associated with the issue. FDA says it is not aware of any associated deaths.