Failure modes in soft-tissue surgical robots: an adjudicated FDA recall cohort, 2005-2026.

Abstract

FDA recall records document corrections and removals; however, product naming, administrative root-cause descriptors, and the functional mechanisms underlying failure are not interchangeable. Accordingly, the affected assets, functional loci, failure modes, and requested actions were characterized in recalls involving soft-tissue surgical robotic systems. A retrospective cohort was constructed from the US Food and Drug Administration (FDA) Medical Device Recall Database and openFDA through 17 Ju