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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 2,107
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.
Part of a larger recall action
This product is one of 7 recalled by SleepNet Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · SleepNet Corporation
See all →- SevereMojo Full Face CPAP Mask Recall: Magnet Safety Update
FDA (Devices) · 2024-04-10
- SevereMojo 2 Full Face Vented Mask Recalled: Magnet Contraindications Updated
FDA (Devices) · 2024-04-10
- SevereMojo 2 CPAP Masks Recalled Worldwide for Magnet Safety Contraindication Update
FDA (Devices) · 2024-04-10
- SevereiQ 2 Nasal Vented Mask Recalled for Magnet Safety Warnings
FDA (Devices) · 2024-04-10
- SevereMojo Non Vented Full Face Mask warning updated for magnet hazard
FDA (Devices) · 2024-04-10
Same hazard · magnet hazard
See all →- High
- HighMattel Recalls Doggie Day Care Toys Due to Magnet Hazard
CPSC · 2007-08-14
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