FDA Official Tells MedCon Class I Device Recalls Rose 232% From 2020 to 2025

The Food and Drug Administration recorded more new class I medical device recall events in 2025 than in recent years, and an agency official told industry the trend is a concern, RAPS reported from the 2026 MedCon conference in Columbus, Ohio, on April 23.

"This is not a trend we're happy about," said Anne Reid, program director of the FDA's Office of Medical Device and Radiological Health Inspectorate, at the conference sponsored by the AFDO/RAPS Healthcare Products Collaborative.

Between 2020 and 2025, class I recalls increased by 232%, Reid said. "[T]hat is a concerning number for us," she told attendees. The FDA's medical device recalls and early alerts page, which lists the most serious device recalls, showed 111 recalls and early alerts in 2025, according to RAPS.

Reid said the agency welcomes companies identifying and reporting recalls themselves, but "we would like to see these numbers drop a bit." She noted that class I recalls take the most resources to track and monitor because of how significant they are.

Recall work falls behind

The FDA's Office of Inspections and Investigations is responsible for processing, monitoring and terminating device recalls. Terminating a recall is "probably the hardest one to get to," Reid said, and the agency is not currently meeting its goals for doing so. She said insufficient staffing, IT systems and limited authorities restrict the FDA's ability to carry out those duties, RAPS reported.

Reid referred to a recent Government Accountability Office report on device recall oversight. In that report, released in December 2025, GAO said that from fiscal years 2020 to 2024 the FDA oversaw the recall of 3,934 medical devices, all voluntarily recalled by manufacturers. GAO said insufficient staff limit the FDA's oversight, and that the agency could not meet its three-month goal for terminating recalls in that period because of resource constraints.

GAO recommended that the Department of Health and Human Services work with the FDA to conduct workforce planning for device recalls and assess whether the agency needs additional authority over manufacturer-initiated recall strategies. HHS concurred with the first recommendation and is taking the second under consideration, according to GAO.

"We have not really addressed it yet. It only closed out in December. We're working on it," Reid said of the report's recommendations, according to RAPS. She added that the agency is "in the process of hiring a lot of people" following the 2025 reductions in force at the FDA.

Forms and complaints

Reid urged manufacturers to use the FDA's device correction and removal report form for industry, which she said cuts the back-and-forth recall coordinators otherwise handle through emails and phone calls. She also said consumer complaints about devices are now routed through a single SmartHub page, where the device center triages them based on urgency.

"Complaints don't just go into a black hole. We really do address them; we work with our Center on it," Reid said.