Sleepnet CPAP and BiPap Mask Recall Issued Over Potential Interference from Magnets

New warning labels will be added to recalled Sleepnet CPAP and BiPAP masks equipped with magnets, indicating that consumers with medical implants should avoid using the products due to serious health risks.

A global recall has been announced for all Sleepnet CPAP and BiPAP masks equipped with magnets, which may interfere with other medical implants, causing them to malfunction or move, potentially resulting in serious injuries or death.

The Sleepnet CPAP and BiPap mask recall was announced by the U.S. Food and Drug Administration (FDA) on March 18, impacting the Mojo, Mojo 2, iQ 2 and Phantom 2 masks, which are equipped with magnets to help them stay in position. However, the CPAP mask magnets can interfere with certain medical implants if they come within close proximity.

The problem was discovered during post market surveillance, according to Sleepnet, which first announced a global recall of the CPAP and BiPAP masks at the beginning of March. However, the FDA has now given the action a Class I recall designation, indicating the problem could result in severe injuries or deaths.

The FDA and Sleepnet indicate no reports of injuries or deaths have been linked to the recalled masks.

“If a patient or anyone (example: household members, bed partners, caregivers, etc.) in close physical contact with the mask has an active medical implant or metallic implant that will interact with magnets, these masks with magnets should not be used,” according to the recall notice, which indicates implants could include pacemakers, defibrillators, nerve stimulators, stents, shunts, dental implants and a variety of other products.

Sleepnet indicates that it is adding new contraindication and safety warnings on the device labels.

Safety Concerns Surrounding CPAP Masks and Machines

The recall is the latest blow to the CPAP industry and users of the breathing assistance devices since a Philips CPAP recall was issued in July 2021, impacting millions of sleep apnea machines.

Over the past three years, thousands of individuals have already come forward to pursue a Philips CPAP lawsuit, alleging that exposure to the toxic foam particles caused them to develop various types of cancer, lung damage and respiratory damage.

Since that recall, there have also been other CPAP mask recalls issued due the same magnet problem.

In September 2022, Philips issued a nearly identical CPAP mask recall for several types of magnet-equipped face masks following dozens of complaints, and reports of serious injuries. Another, very similar, ResMed CPAP mask recall was announced earlier this year, affecting more than 20 million masks containing magnets, after reports of several injuries.

Sleepnet CPAP and BiPAP Mask Recall

The recall affects all Mojo Full Face Vented Mask, Mojo Full Face Non‐Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non‐ Vented Mask, Mojo 2 Full Face AAV Non‐Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Masks, regardless of lot or UDI number. The masks have been distributed worldwide since 2006.

“If a patient, or anyone in close physical contact, has an active medical implant or metallic implant, they should contact their mask supplier to find a replacement mask that does not include magnets,” the manufacturer advises. “If the patient is unsure whether or not they should use the mask, they should consult their physician or the manufacturer of their implant.”

The company advises consumers with questions to contact Sleepnet at hkoppusetty@sleepnetcorp.com or call 1‐800‐742‐3646. Adverse events linked to the use of the recalled masks should be reported to the FDA’s MedWatch Adverse Event Reporting Program.