Because software as a medical device (SaMD) does not come into direct contact with patients, it does not pose such direct harm as that caused by conventional hardware medical devices (non-SaMD) ; however, SaMD does present indirect harm. Using US recall data, the objective of this study was to investigate indirect harm caused by software medical devices including both SaMD and non-SaMD. We collected recall data in which the cause was determined by the US Food and Drug Administration to be software design, and we determined whether the product in each recall was SaMD or not (non-SaMD). We also classified the failure mode of each recall into four groups : physical (Group 1) ; information-related (Group 2), data-related (Group 3) ; and other (Group 4). We identified 6,393 recalls for 2009-2014, and 712 software-caused recalls. Of those, the leading failure mode was Group 2 that can lead to indirect harm and accounted for 408 (57%), followed by Group 1 that can lead to direct harm and accounted for 122 (17%). Of 408 Group 2 recalls, 387 (95%) were recall class Ⅱ and 6 (1%) were recall class Ⅰ. Of the 6, 4 were for non-SaMD and 2 were for SaMD. The findings revealed by this study indicate the importance of the further understanding of safety of information presentation functionality and the necessity of further discussion of safety measures.