Medical Device Recall: Mojo 2 Full Face AAV Non Vented Mask, All Sizes
SleepNet Corporation · March 1, 2024
Reason for Recall
Update to contraindications and warning language due to CPAP masks containing magnets.
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.
States Affected
NATIONWIDE
Quantity Affected
1,268 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1355-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.