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SleepNet Corporation FDA Recalls

7 recalls on file across devices, 7 of them Class I and 7 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
iQ 2 Nasal Vented MaskClass IMar 1, 2024Update to contraindications and warning language due to CPAP
Phantom 2 Nasal Vented MaskClass IMar 1, 2024Update to contraindications and warning language due to CPAP
Mojo Non Vented Full Face Mask with Headgear, All SizesClass IMar 1, 2024Update to contraindications and warning language due to CPAP
Mojo 2 Full Face AAV Non Vented Mask, All SizesClass IMar 1, 2024Update to contraindications and warning language due to CPAP
Mojo 2 Full Face Non Vented Mask, All SizesClass IMar 1, 2024Update to contraindications and warning language due to CPAP
Mojo Full Face with Headgear, All SizesClass IMar 1, 2024Update to contraindications and warning language due to CPAP
Mojo 2 Full Face Vented Mask, All SizesClass IMar 1, 2024Update to contraindications and warning language due to CPAP

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