Abstract: ObjectiveTo investigate the occurrence of serious medical device risks and provide reference for the post-marketing medical device risk management through statistical analysis on 272 cases of FDA class I medical device recalls. MethodsStatistical analysis is applied to the retrieval of 2001~2012 the most serious class I medical device recalls from FDA website which does not involve the cases caused by illegal factors. ResultsThe constituent ratio of the top 10 categories of products accounts for 90% of the number of cases. Energy hazard is the main form, accounting for 79.4%. The product component failure is the main direct reason, accounting for 76.1%. ConclusionSerious medical device risks are mainly related to applied part, component reliability and function, energy control,