The Recall Desk
SevereFDA (Devices)·Z-1354-2024·Announced 2024-04-10

Mojo 2 Full Face Non Vented Mask Recalled for Magnet Safety Concerns

SleepNet Corporation is recalling Mojo 2 Full Face Non Vented Masks due to magnets in the device and updated contraindications and warnings. The recall affects 2,107 units distributed worldwide.

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: This FDA Class I medical device recall addresses safety concerns related to magnets in CPAP masks. While no injuries or deaths are reported in the source material, Class I designation requires a minimum severity score of 4.

Plain-English summary

SleepNet Corporation is recalling Mojo 2 Full Face Non Vented Masks in all sizes. The recall encompasses 2,107 units distributed worldwide, including the United States and numerous other countries.

The recall is prompted by an update to contraindications and warning language related to magnets contained in the masks. The FDA has designated this as a Class I recall due to potential safety concerns these magnets present.

All lot numbers and UDI-DI codes are included in the recall. Consumers should review any updated materials from the manufacturer regarding contraindications and warnings associated with this product.

The recalled product

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

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.