This article includes a retrospective review of fatalities caused by transfusion-related acute lung injury (TRALI) over a 5-year period (from 1997 to 2002) that were reported to the Center for Biologics Evaluation and Research involving 58 recipient deaths and the corresponding 63 blood component donors. Descriptive statistics are presented. Recipient characteristics include age, sex, and admitting diagnosis. Cardiovascular disease, pulmonary disorders, and cancer were the most frequent diagnoses of transfusion recipients. Reported deaths did not appear to be associated with age, sex, reason for transfusion, or transfusion component. Implicated blood component(s) and clinical symptoms at the time of reaction were recorded. Fresh frozen plasma was implicated in one half of the cases, whereas red blood cells played a role in approximately one third. The clinical characteristics described most often in TRALI reports included shortness of breath, frothy sputum, pulmonary infiltrates, and hypoxia. Donor variables included age, sex, parity, and laboratory tests for antibodies to HLA and/or antigranulocyte antibodies. Laboratory tests showed HLA antibodies and/or antigranulocyte antibodies were positive in the majority of donors tested. More data are needed to better describe the role of antibodies in these reactions. Greater awareness is crucial for the practitioner to be alert for signs and symptoms of TRALI and to be aware of the necessary steps in treatment.