In September of 2022, Philips Respironics announced a product recall related to a safety issue that affects some of their CPAP masks. Find out more details below, including information on potential health risks, which masks are being recalled, and who who to contact with questions.
What to Know
- On September 6, 2022, Philips Respironics announced a voluntary recall of 17 million of its sleep apnea masks.
- The magnetic headgear clips used in theses masks can interfere with some implanted metallic medical devices.
- This potential health risk applies to the primary users of the masks as well as bed partners who may have one of these implants.
- It’s important for everyone who uses a BiPAP (bilevel positive airway pressure) or CPAP (continuous positive airway pressure) machine to check to see whether their masks are part of this recall.
- If you discover your mask on the list of recalled devices, switch to a nonmagnetic mask and contact your healthcare provider.
- This recall is not related to the 2021 voluntary recall of some Philips Respironics CPAP machine models.
- No other brands’ masks, or other Philips masks that aren’t on the list below, are affected by this recall.
Who Is Affected by This Recall?
People who use any of the Philips masks listed below (or who sleep near someone who does) AND who have a metallic implant or metal objects in their body could be affected. Philips advises that others can continue to use these masks as directed.
Implanted medical devices that could be impacted include things like pacemakers, metallic stents, aneurysm clips, insulin pumps, ocular implants, cardioverter defibrillators, and more. People who have shrapnel or other metal objects lodged in their body are similarly at risk if they use the recalled masks. Contact your healthcare provider with any questions or concerns about medical device implants used by you or a loved one.
*People who use other brands’ masks, or Philips Respironics masks that aren’t on the list below, are NOT affected by this recall.
Which Masks Are Being Recalled?
The recall applies ONLY to the Philips CPAP masks listed below:
- Amara View Full Face Mask
- DreamWisp Nasal Mask
- Wisp and Wisp Youth Nasal Mask
- DreamWear Full Face Mask
- Therapy Mask 3100 NC/SP
Which Alternatives Are Recommended?
If you're using the Amara View Full Face CPAP Mask, the masks below are good alternatives
If you're using the DreamWisp Nasal CPAP Mask, the masks below are good alternatives
If you're using the DreamWear Full Face CPAP Mask, the masks below are good alternatives
Where Can I Get More Information?
Anyone with questions may contact Philips Respironics customer service at 800-345-6443 from Monday through Friday, 8:30 a.m. ET to 8 p.m. ET. Read the US Food and Drug Administration’s full statement and recommendations related to this recall on the FDA website.