The Recall Desk
SevereFDA (Devices)·Z-1351-2024·Announced 2024-04-10

Mojo Full Face CPAP Mask Recall: Magnet Safety Update

SleepNet Corporation is recalling 23,042 Mojo Full Face CPAP masks worldwide because the masks contain magnets that require updated contraindications and warning language.

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: FDA Class I classification for medical devices requires a minimum severity rating of 4 (Severe). No deaths or serious injuries are documented in the source text; the recall addresses the potential hazard posed by magnets through updated warnings.

Plain-English summary

SleepNet Corporation is recalling all sizes of the Mojo Full Face with Headgear CPAP mask. The recall affects 23,042 units distributed nationwide in the United States and internationally to over 40 countries worldwide.

The masks contain magnets, and this FDA Class I recall has been initiated to update the contraindications and warning language for these devices. Updated warnings are necessary to ensure patients and healthcare providers have appropriate guidance regarding use of masks with magnetic components.

The recall applies to all UDI-DI codes and all lot numbers. If you are using one of these masks, you should contact SleepNet Corporation for information about your specific device and available alternatives.

The recalled product

Product
Mojo Full Face with Headgear, All Sizes
Manufacturer
SleepNet Corporation
Hazard
  • magnet-hazard

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.