Premarket clinical evidence strength and recalls of high-risk therapeutic medical devices

About the Study : In this cross-sectional study, more than one-third of high-risk therapeutic medical devices were subject to serious recalls. Because device, premarket clinical evidence, and regulatory characteristics were not consistently associated with serious recalls, robust postmarket surveillance is needed to ensure patient safety.

Corresponding Author : Maryam Mooghali, MD, MSc, Department of Internal Medicine, Yale School of Medicine, 330 Cedar St, New Haven, CT 06510 ( maryam.mooghali@yale.edu ).

10.1001/jamahealthforum.2026.2626

To access the embargoed study: Visit our JAMA Network Media Center at this link https://media.jamanetwork.com/

Link to the article in your story
We encourage you to link out to this article in your story using the link below. It includes an access token that will give free access to the article for your readers up to one year after publication. (The link will be live after the article publishes and embargo is lifted.)

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

Editor's Note : Please see the article for additional information, including full author list, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

JAMA Health Forum