ResMed CPAP masks subject to Class I recall over magnetic interference issue

Key takeaways:

• ResMed CPAP masks that contain magnets are being recalled due to possible magnetic interference with medical devices.
• ResMed will add more specific labels saying which devices could be affected.

Six reported injuries related to magnets on the headgear of CPAP machines by ResMed Ltd. have resulted in a recall the FDA labels as class I, the most serious kind, according to an an FDA alert.

The company is recalling all the CPAP masks it makes containing magnets due to concerns that magnetic interference could disrupt medical devices, causing serious injury or death, according to the alert. The recall covers model numbers AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30 and AirFit F30i.

The magnets are located on the masks’ lower headgear straps and frame connections. There is a label on the masks advising users to keep the magnets 2 inches away from affected medical devices, but it does not say which devices could be affected, according to the alert. ResMed plans to add more specific warning labels and information about what devices should be kept away from the magnets.

The recall was issued following a review of potential magnetic interference risks to medical devices, the FDA alert stated. All affected customers were issued an advisory on Dec. 8, 2023, asking them to keep the magnets 6 inches away from their implants or medical devices and to check ResMed’s website for updates on contraindications and warning labels.