A Scoping Review of the Use of Medical Device Recall Data —Identifying Research Priorities in Japan—

This scoping review aims to comprehensively map the existing literature on medical device recalls and to characterize studies evaluating regulatory or premarket systems using recall outcomes, as well as studies examining the characteristics, causes, and risks of medical device recalls. The review will primarily focus on medical devices in Japan, the United States, Europe, Canada, and Australia. Eligible studies will be categorized into two main areas: A. Studies evaluating regulatory or premarket systems using recall outcomes This category will include studies in which recalls are a primary outcome or analytical focus and that evaluate premarket regulatory pathways (e.g., 510(k), PMA, and CE marking), approval or certification systems, or the effectiveness of regulatory systems using recall data. B. Studies on recall characteristics, causes, and risks This category will include studies in which recalls are the primary subject of investigation and that examine the number of recalls, temporal trends, recall classes, medical device classifications, causes of recalls, risk factors, or recall-related risk assessments. Studies will be excluded if recalls are only a secondary outcome or if recalls are not a primary analytical focus of studies evaluating approval or regulatory systems. Studies primarily addressing adverse event analyses, safety information communication, post-market surveillance in general, or the development of AI, machine-learning, or predictive models for recall prediction will also be excluded. Studies focusing exclusively on operational or logistical aspects of recalls, including healthcare institution responses, manufacturer responses, individual recall cases without broader, generalizable insights, inventory management, or recall implementation procedures, will be excluded. Studies focused on in vitro diagnostic devices (IVDs), unique device identification (UDI), patient awareness, media, business and financial outcomes, or products regulated as medical devices in other jurisdictions but not classified as medical devices in Japan will also be excluded. This review will map the scope and characteristics of existing research on medical device recalls and synthesize research findings concerning the evaluation of regulatory and premarket systems using recall data and the characteristics, causes, and risks of recalls. The findings will also be used to identify potential research questions and areas for future research using medical device recall data in Japan.