Mojo Non Vented Full Face Mask warning updated for magnet hazard
SleepNet is updating safety warnings and contraindications for its Mojo Non Vented Full Face Mask due to magnet content. All 11,874 affected units are subject to this warning update.
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 indicates a reasonable probability of serious adverse health consequences. Although no specific injuries or deaths are reported in this notice, the Class I designation reflects the potential for serious harm from magnet-related hazards, warranting a Severe severity rating.
Plain-English summary
The FDA has issued a Class I recall of approximately 11,874 units of the Mojo Non Vented Full Face Mask with Headgear (all sizes) manufactured by SleepNet Corporation. The recall involves an update to safety warnings and contraindications related to magnets present in the masks.
The masks contain magnets that necessitate updated warning language and contraindication information. Revised safety guidance is being provided to address hazards associated with these magnetic components.
The affected masks have been distributed worldwide, including throughout the United States and in numerous countries internationally. All lot numbers and UDI-DI codes are included in this recall.
Patients and healthcare providers are advised to review the updated safety information and contraindications provided by SleepNet. Users should consult this updated guidance before continuing use of the product.
The recalled product
- Product
- Mojo Non Vented Full Face Mask with Headgear, All Sizes
- Manufacturer
- SleepNet Corporation
- Category
- Medical Device — CPAP Mask
- 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.
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