Transfusion-transmitted bacterial sepsis is the third most common cause of transfusion-related fatalities reported to the Food and Drug Administration. Between October 1, 1995, and September 30, 2004, there were 665 reported transfusion fatalities. Eighty-five (13%) deaths were due to transfusion-transmitted bacterial infections, of which 58 (68%) were due to gram-negative organisms. The most common gram-negative organism associated with transfusion-transmitted deaths after receipt of platelets was Klebsiella pneumoniae. This article summarizes retrospectively the case series of deaths due to transfusion-transmitted K pneumoniae infection, reported to the Food and Drug Administration, 1995 to 2004. There were 12 deaths due to transfusion-transmitted K pneumoniae infection with 7 (58%) of the 12 cases occurring in 2002. Eleven deaths were caused by the transfusion of contaminated platelets and 1 death attributed to contaminated red blood cells. Extensive review of the seven 2002 fatality reports did not identify a common (shared) lot for items used during collection or processing of the blood product. In conclusion, in cases of suspected transfusion-transmitted septicemia, broad spectrum antibiotic coverage including coverage of gram-negative organisms should be considered. Strict adherence to infection control measures while collecting, processing, and handling all blood and blood components in both the clinical settings and in the laboratory should be followed. Further development of simple and effective test procedures for detecting bacteria in the blood is needed.