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# Philips Mask Recall is Class 1
- URL: https://www.fdaweb.com/philips-mask-recall-is-class-1/
- Published: 2022-10-19T12:00:00.000Z
- Updated: 2026-09-14T18:03:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153001

FDA says the Philips Respironics 8/2 recall of 18,670,643 select masks for BiPAP and CPAP machines is Class 1\. Philips says the devices were distributed between 1/1/2015 and 9/9/2022\. An FDA [notice](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 they were recalled due to a “serious safety concern” involving the magnetic headgear clips that hold the masks in place. The agency 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 metallic medical devices or metallic objects in their bodies.

As of 9/9, the notice says, there have been 43 complaints, including 14 with serious injuries, associated with the issue. FDA says it is not aware of any associated deaths.