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.
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: 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
- Affected units
- 23,042
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 2 Full Face Non Vented Mask Recalled for Magnet Safety Concerns
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
Similar recalls
- SeverePhilips Respironics DreamWear Full Face Mask Lacks Magnetic Hazard Warning
FDA (Devices) · 2022-10-12
- SevereCPAP Full-Face Mask Recalled for Missing Implantable Device Warnings
FDA (Devices) · 2022-10-12
- SevereDreamWisp CPAP mask recalled for missing implant safety warnings
FDA (Devices) · 2022-10-12
- SevereAirFit F30i Full Face Mask Recalled Due to Magnetic Interference Risk
FDA (Devices) · 2023-12-27
- SevereCompass Health Brands Recalls CPAP Mask Cushions Due to Design Incompatibility
FDA (Devices) · 2018-08-29
- SevereAirTouch F20 Full Face Mask Recalled for Magnetic Interference with Medical Implants
FDA (Devices) · 2023-12-27