Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum.

The study, published on Aug. 22, looked at 950 AI medical devices authorized by the Food and Drug Administration through November 2024. Sixty of the devices were associated with 182 recall events.

The most common causes of recalls were diagnostic or measurement errors, followed by functionality delay or loss. About 43% of all recalls also took place within one year of FDA authorization.

Tinglong Dai, lead author of the study and a professor at the Johns Hopkins Carey Business School, said the “vast majority” of recalled devices had not undergone clinical trials. For the majority of AI-enabled device

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