The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Names: AirFit and AirTouch masks
- Product Codes: See Recall Database Entries:
- Model Numbers: AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, AirFit F30i
- Distribution Dates: January 2020 to November 20, 2023
- Devices Recalled in the U.S.: 20,414,357
- Date Initiated by Firm: November 20, 2023
Device Use
The AirFit and AirTouch masks are non-continuous ventilatory devices, intended to be used by patients weighing more than 66 lbs. who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The masks are meant for reuse by one person at home or by multiple people in hospitals.
The devices have magnets on the lower headgear straps and frame connections of CPAP masks. These magnets are there to make wearing the mask more comfortable.
Reason for Recall
ResMed Ltd. is recalling all their Continuous Positive Airway Pressure (CPAP) masks with magnets due to possible magnetic interference with certain medical devices. Under certain circumstances when a magnet is in close proximity (less than 2 inches) to certain medical implants and devices, it might disrupt their function or position, possibly causing serious harm or death.
While the existing label advises keeping magnets 2 inches away from affected medical devices, it doesn't list all the specific ones that could be affected by the masks' magnets. ResMed is recalling these masks to update the labels, add more warnings and information to guide patients and health care professionals on safe usage when using masks with magnets. This recall and label update came after a review of potential risks to medical implants due to magnetic interference.
The use of affected masks may cause serious adverse health consequences and death.
There have been six reported injuries. There have been no reports of death.
Who May be Affected
- People who have been prescribed an AirFit or AirTouch mask for non-invasive positive airway pressure (PAP) therapy or bi-level therapy.
- Healthcare providers working in home-care or hospital settings who use an AirFit or AirTouch mask to administer non-invasive positive airway pressure (PAP) therapy or bi-level therapy.
What to Do
On December 8, 2023, ResMed sent all affected customers an Important Medical Device Advisory.
The letter requested customers to:
- Keep the magnets at a safe distance of six inches (150 mm) away from implants or medical devices that could be affected by magnetic interference.
- Patients should reach out to their physician or the manufacturer of their implant or other medical device for further details regarding possible negative effects of magnetic fields on their device.
- Visit the ResMed Magnet Update website for detailed information about the recent updates made to contraindications and warning labels.
