CPAP masks with magnets: the FDA notices and who must avoid them

Why some masks use magnets

The FDA's recall entry for one maker's masks describes “magnets on the lower headgear straps and frame connections”, there “to make wearing the mask more comfortable”^[1]. Another maker's notice says magnetic headgear clips are “commonly used in the sleep therapy devices industry” ^[2].

The concern is not the mask itself but what the magnets can do near certain implants. The FDA says the magnets “can cause potential injuries or death when the magnets interfere with certain implanted metallic medical devices or metallic objects in the body”^[3].

What the FDA notices say

The January 2024 safety communication

On January 18, 2024, the FDA published a safety communication about ResMed masks with magnets and classified the recall as Class I, “the most serious type of recall”^[3]. The FDA's recall entry adds that “this recall is a correction, not a product removal”: the masks were relabeled with more warnings. The earlier label advised keeping the magnets 2 inches from affected devices, and the update asks for “a safe distance of six inches (150 mm)” ^[1].

The FDA reports that “Six injuries have been reported” and that “There have been no reports of deaths.” The reported devices included an implantable cardioverter defibrillator, a cochlear implant, a cerebrospinal fluid shunt, and brain and dental implants^[3].

The FDA lists the affected families as the AirFit F20 and AirTouch F20 (including the “for Her” versions and the F20 NV), the AirFit F30 and F30i, and the nasal AirFit N10, AirFit N20 and AirTouch N20^[3]. The recall entry gives distribution dates of January 2020 to November 20, 2023^[1]. The FDA page links the maker's safety notice, which shows where to find the model name and the magnets on the mask^[3].

The September 2022 notice

On September 6, 2022, Philips Respironics announced, through the FDA, updated instructions and a new contraindication for certain masks with magnetic headgear clips. They “should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body”, and should be kept “at least 6 inches (approx. 15 cm) away” from other implants or medical devices that magnets can affect. The company had received “14 reports” as of August 30, 2022^[2]. The list of affected masks is on the linked notice.

The March 2024 notice

On March 1, 2024, Sleepnet announced a worldwide recall of its CPAP and BiPAP masks with magnets, published by the FDA. It adds a contraindication for anyone in close physical contact with the mask who has a listed implant, sets the distance at “at least 6 inches (approx. 16 cm)”, and says people affected should “contact their mask supplier to find a replacement mask that does not include magnets”^[4]. Its list of masks is on the linked notice.

The implants the notices list

The lists differ slightly between notices, and each is a list of examples, not a complete one. The FDA's 2024 safety communication includes, among others^[3]:

• Pacemakers and implantable cardioverter defibrillators
• Metallic stents
• Neurostimulators, and magnetic metallic implants, electrodes and valves in the upper limbs, torso, neck or head
• Cerebral spinal fluid shunts, aneurysm clips and embolic coils
• Metallic cranial plates, screws and burr hole covers
• Ocular implants and certain contact lenses with metal
• Implants to restore hearing or balance that have an implanted magnet, such as cochlear implants
• Dental implants
• Implantable ports and pumps, such as insulin pumps
• Metallic splinters in the eye and metallic shrapnel in the body

The 2022 notice adds items such as hypoglossal nerve stimulators, magnetic denture attachments and devices labeled as MR unsafe^[2]. If you are not sure whether an implant counts, the FDA's recall entry says to ask your physician or the maker of the implant^[1].

Who must not use a mask with magnets

The advice covers two groups of people, not one. The FDA says to “Stop use of the recalled mask and switch to a non-magnetic mask, if available” if you have one of the listed implants or metallic objects, and that this “also applies if anyone in close physical contact with the mask has” one^[3]. The 2022 notice names them: household members, caregivers and bed partners^[2].

The other side is just as clear. The FDA says “You may continue to use the recalled mask if neither you nor anyone in close physical contact with the mask have any of the implanted metallic medical devices or metallic objects” on the list^[3].

What to do

1. Find out whether your mask has magnets: look at the label, the model name and the user instructions, or ask your supplier.
2. Think about everyone who sleeps or spends time close to the mask, not only yourself.
3. If anyone has a listed implant, follow the notices: stop using the mask with magnets, switch to a non-magnetic mask if one is available, and “Consult with your health care provider”^[3].
4. Ask your mask supplier for a mask without magnets. The FDA says the maker of the 2024 list is making replacement masks without magnets available to mask providers^[3].
5. Keep any mask with magnets at least 6 inches from other implants and medical devices that magnets can affect^[2].

Your doctor and your supplier decide which mask you move to. The fit finder and the mask types guide explain the types to ask about, and the size chart guide marks which families appear on an FDA magnet list.

The 2021 CPAP machine recall was not about masks

Two different issues are often mixed up. In June 2021, Philips “recalled certain ventilators, continuous positive airway pressure (CPAP) machines, and bi-level positive airway pressure (BiPAP) machines”. The reason was inside the devices: “The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down.” On April 9, 2024, a federal district court entered a consent decree against the company^[5].

That recall concerned machines. The magnet notices above concern masks and their headgear clips, and came later, in 2022 and 2024. If you have questions about a machine, the FDA page on that recall is in the sources below; for a mask, the magnet notices are the ones that apply.