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Recall Observatory FDA recall evidence

Device product

Mojo Full Face with Headgear, All Sizes

Z-1351-2024

March 01, 2024

Class I

Product summary

Firm
SleepNet Corporation
Event
Event 94169
Status
Ongoing
Classification
Class I
Quantity
23,042 units
Official record key
device-enforcement:Z-1351-2024

Official wording

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

Code information: All UDI-DI; All Lot Numbers.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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