FDA medical device Class 1 recalls trend upward

Editor's Note

The number of US Food and Drug Administration (FDA) Class 1 recalls—the most serious classification—for medical devices has been trending upwards. Regulatory News, a publication of the Regulatory Affairs Professional Society (RAPS), reported the news April 25. 

According to the report, Anne Reid, program director of the Office of Medical Devices and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the FDA, told attendees the trend was a “grave concern for us” during the 2024 MedCon conference, sponsored by the Association of Food and Drug Officials (AFDO)/RAPS Healthcare Products Collaborative and the FDA.

Medical devices lead the number of recalled products in fiscal years 2012 through 2024, with a total of 32,336 recalls occurring over that time period compared to product types such as food and cosmetics (26,184 recalls), drugs (16,137 recalls), and biologics (11,605 recalls), Reid reportedly said. The most common root causes for class 1 recalls are process control, device design, and nonconforming material.

The full report provides additional context on the trend and how the FDA is responding.