The US Food and Drug Administration has identified ResMed’s recall of over 20 million AirFit and AirTouch CPAP masks with magnets as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
In November, ResMed issued an urgent field safety notice, alerting customers that the company was recalling all of its 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 two 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 two 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.
The recalled products:
- Product names: AirFit and AirTouch masks
- Model numbers: AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, AirFit F30i
- Distribution dates: January 2020 to Nov 20, 2023
- Devices recalled in the US: 20,414,357
- Date initiated by firm: Nov 20, 2023
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or fax.