ResMed recalls CPAP Masks with magnets, USFDA terms it most serious
US: ResMed Ltd. has recalling all their Continuous Positive Airway Pressure (CPAP) masks with magnets due to possible magnetic interference with certain medical devices, the U.S. Food and Drug Administration (USFDA) said.
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.
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, the USFDA stated
"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 release added
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.
Recalled Product
• Product Names: AirFit and AirTouch masks
• Product Codes: See Recall Database Entries:
• Class 1 Device Recall AirFit N10
• Class 1 Device Recall AirFit F20
• Class 1 Device Recall AirTouch F20
• Class 1 Device Recall AirFit N20
• Class 1 Device Recall AirTouch N20
• Class 1 Device Recall AirFit F30
• Class 1 Device Recall AirFit F30i
• 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.
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
º 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.
In an official statement to Medical Dialogues, ResMed said, "On November 20, 2023, ResMed issued a Field Safety Notice to voluntarily update the Instructions for Use in masks with magnets due to potential magnetic inference when the magnets are used in close proximity to certain medical devices. It is important to note that the Food and Drug Administration’s recent issuance of a Class I recall acknowledges this classification is due to a correction of the product’s labeling and not a product removal. Anything contrary is incorrect and should be corrected to ensure the correct information reaches consumers.
ResMed masks containing magnets remain on the market and are safe when used in accordance with the updated Instructions for Use, including the contraindications and warnings. Refer to the ResMed Magnet Update website for more information about the updates issued to contraindications and warnings.”
