Although TRALI remains rare, it has been the leading cause of transfusion-related death reported to the FDA since 2001. This increase is likely due to prior underdiagnosis and under-reporting of cases of TRALI and not due to an increase in the number of cases of TRALI. The fatality rate of 5-20% associated with TRALI is the highest for all transfusion reactions, and in the intensive care setting, the mortality rate may be as high as 47%. The incidence of TRALI varies widely due to varying definitions used. TRALI is the most common adverse reaction associated with transfusion of blood products with reported incidences in North America ranging from 1 in 5,000 to 1 in 1,323 transfusions and reported incidences in Europe ranging from in 1,000,000 to 1 in 7,900.