CLASS I ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report

Mojo Non Vented Full Face Mask with Headgear, All Sizes recalled

SleepNet is recalling Mojo Non Vented Full Face Mask with Headgear, All Sizes, distributed nationwide in the US. The recall was initiated on 1 Mar 2024 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll UDI-DI; All Lot Numbers.

Quantity recalled11,874 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1352-2024
FDA event ID: 94169
Recalling firm: SleepNet, Hampton, NH
Classification: Class I
Status: Ongoing
Recall initiated: 1 Mar 2024
FDA classified: 1 Apr 2024
Reported: 10 Apr 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Masks, Gloves & PPE

Timeline

1 Mar 2024	Recall initiated by company
1 Apr 2024	Classified by FDA	+31 days
10 Apr 2024	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Update to contraindications and warning language due to CPAP masks containing magnets.

Product as listed by the FDA

Mojo Non Vented Full Face Mask with Headgear, All Sizes

Where it was distributed

Worldwide distribution - US Nationwide and the countries of AUSTRIA, BAHRAIN, BRAZIL, COLOMBIA, COSTA RICA, ECUADOR, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, INDIA, IRAQ, IRELAND, ISRAEL, ISREAL, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NORWAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SULTANATE OF OMAN, SWEDEN, SWITZERLAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VIETNAM, YEMEN.

Nationwide

Questions about this recall

Is Mojo Non Vented Full Face Mask with Headgear, All Sizes recalled?

Yes. SleepNet recalled Mojo Non Vented Full Face Mask with Headgear, All Sizes on 1 Mar 2024. The recall is Class I and its status is Ongoing. Recall number Z-1352-2024.

Why was it recalled?

Update to contraindications and warning language due to CPAP masks containing magnets.

Which lots are affected?

All UDI-DI; All Lot Numbers.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from SleepNet

All 7

Reported	Class	Recall	Company	Reason	Where
10 Apr 2024Device	CLASS I	Mojo Full Face with Headgear, All Sizes recalled by SleepNet	SleepNet	Other	Nationwide
10 Apr 2024Device	CLASS I	Phantom 2 Nasal Vented Mask recalled by SleepNet	SleepNet	Other	Nationwide
10 Apr 2024Device	CLASS I	Mojo 2 Full Face Vented Mask, All Sizes recalled by SleepNet	SleepNet	Other	Nationwide
10 Apr 2024Device	CLASS I	Mojo 2 Full Face Non Vented Mask, All Sizes recalled by SleepNet	SleepNet	Other	Nationwide
10 Apr 2024Device	CLASS I	iQ 2 Nasal Vented Mask recalled by SleepNet	SleepNet	Other	Nationwide

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