FDAClass IApril 10, 2024

Mojo 2 Full Face Vented Mask recall

Mojo 2 Full Face Vented Mask, All Sizes

Why was Mojo 2 Full Face Vented Mask recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All UDI-DI; All Lot Numbers.

Product
Mojo 2 Full Face Vented Mask, All Sizes
Recalling firm
SleepNet Corporation
Quantity
2,787 units
Distribution
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.
Recall date
April 10, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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