More than a third of high-risk medical devices subject to serious recalls, study finds

Premarket evidence and regulatory characteristics offered little predictive value, researchers report in JAMA Health Forum

More than one-third of high-risk therapeutic medical devices authorised for use in the United States have been subject to a serious recall, according to a cross-sectional study published today in JAMA Health Forum.

The study examined the relationship between the strength of premarket clinical evidence supporting high-risk therapeutic devices and their subsequent recall history. Serious recalls — those involving a reasonable probability of serious adverse health consequences or death — were identified in over 35% of the devices assessed.

Critically, the researchers found that device characteristics, the strength of the premarket clinical evidence submitted to regulators, and regulatory characteristics were not consistently associated with whether a device went on to be seriously recalled. In other words, stronger evidence at the point of approval did not reliably predict a safer performance record once the device reached patients.

The authors conclude that robust postmarket surveillance is needed to ensure patient safety, and that premarket review alone cannot be relied upon to identify devices that will later present serious risks to patients.

The corresponding author is Maryam Mooghali, MD, MSc, of the Department of Internal Medicine, Yale School of Medicine.

Study: Premarket Clinical Evidence Strength and Recalls of High-Risk Therapeutic Medical Devices
Journal: JAMA Health Forum
DOI: 10.1001/jamahealthforum.2026.2626
Full article (free access for readers for one year): https://jamanetwork.com/journals/jama-health-forum/fullarticle/10.1001/jamahealthforum.2026.2626?guestAccessKey=0809ea7a-d9c4-44c3-b758-f5703f67bccd&utm_source=for_the_media&utm_medium=referral&utm_campaign=ftm_links&utm_term=080726