The Recall Desk
SevereFDA (Devices)·Z-1355-2024·Announced 2024-04-10

Mojo 2 CPAP Masks Recalled Worldwide for Magnet Safety Contraindication Update

SleepNet Corporation is recalling Mojo 2 Full Face CPAP masks (1,268 units worldwide) to update contraindications and warning language due to magnets in the masks. The FDA classified this as a Class I recall.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall, which per the severity rubric requires a minimum score of 4 (Severe). While no reported illnesses or injuries are mentioned in the source, the Class I classification indicates a serious hazard situation involving magnets that requires updated contraindications and warnings.

Plain-English summary

SleepNet Corporation is recalling Mojo 2 Full Face AAV Non Vented Masks in all sizes, affecting approximately 1,268 units distributed worldwide across the United States and to numerous countries internationally. This recall was initiated due to the need to update contraindications and warning language on the masks, which contain magnets.

The U.S. Food and Drug Administration has classified this as a Class I recall, indicating a serious hazard situation. Consumers currently using this product should review any updated contraindications and warning information when provided by the manufacturer.

For additional information or questions about the recall, consumers should contact SleepNet Corporation directly.

The recalled product

Product
Mojo 2 Full Face AAV Non Vented Mask, All Sizes
Manufacturer
SleepNet Corporation
Hazard
  • magnet-interference

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • All UDI-DI
  • All Lot Numbers.

Distribution

Distributed nationwide across the United States.