The Food and Drug Administration lacks adequate staffing to oversee medical device recalls, according to a report released Friday by the U.S. Government Accountability Office.
The report, which tracked medical device recalls from fiscal year 2020 to 2024, found that insufficient staff limits the FDA’s ability to conduct oversight activities. During the four-year period, 3,934 devices were recalled in the U.S. The FDA couldn’t meet its goal of terminating recalls within three months due to resource constraints, according to the report.
“FDA’s challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk,” the GAO wrote.
The GAO’s report follows a call by the watchdog in 2011 for the FDA to enhance its oversight of recalls. The report was used to support the Food and Drug Administration Safety and Innovation Act, but experts have said revisions to medical device safety were not enough.
In December 2023, Sens. Richard Durbin, D-Ill., and Richard Blumenthal, D-Conn., called for the GAO to review how the FDA handled device recalls. In the request, the senators cited Philips’ recall of more than 15 million respiratory devices, which began in 2021.
The timeframe discussed in the latest GAO report took place before the Department of Health and Human Services enacted sweeping cuts in February and April. The cuts included staff at the FDA’s device center, as well as people who supported inspections of drugs, vaccines and medical devices across the agency.
The Office of Inspections and Investigations, which leads inspections, investigations and law enforcement activities across the products the FDA regulates, restructured in 2024, moving all device recall coordinators into one centralized branch, according to the report. The OII also started hiring additional recall staff, but was not able to fill those positions due to a hiring freeze that started in early 2025.
OII officials said in the report that there are more medical device recalls than biologics or drugs in any given year. Device recalls can be more complex, as they can incorporate both physical devices and software.
By the numbers
In fiscal year 2024, the FDA had the following recalls, according to the GAO:
1,017
Medical device recalls
The OII officials said they often don’t have sufficient staff for device recall activities, such as reviewing manufacturer recall status reports and conducting in-person recall audit checks. Staff prioritize the highest risk recalls and the earlier stages of the recall process, leaving recall termination on the “back burner” due to limited resources.
“FDA acknowledges staffing constraints, but the agency does not have comprehensive information on the number and type of staff that would be sufficient to conduct its oversight of device recalls,” the GAO wrote.
The report also mentioned the HHS’ previous plans to reduce the FDA’s workforce in March. At the time, HHS Secretary Robert F. Kennedy Jr. outlined plans to cut about 10,000 people across the department, including about 3,500 FDA workers.
The watchdog recommended that the HHS work with the FDA to conduct workforce planning for device recalls. The HHS agreed with the recommendation, according to the report.
The HHS did not respond to questions from MedTech Dive about how it plans to determine workforce needs, the status of the hiring freeze and whether it plans to reinstate fired staff.
More recall authority
The FDA may also benefit from stronger authority to require device manufacturers to adopt its recommendations around recalls.
While the FDA does have the authority to mandate recalls, it rarely uses it because it requires a time-intensive, multistep process. The FDA has used this authority just four times since receiving it in 1990, according to the report.
Almost all device recalls are voluntary, and the vast majority stem from issues identified by manufacturers.
In some cases, the FDA has faced challenges when it disagreed with how a manufacturer is handling a recall. In one case, the agency believed a recall warranted a press notification to the public, but the manufacturer didn’t want to make an announcement. The FDA ultimately issued its own safety communication.
There have also been instances where the FDA wanted a manufacturer to conduct additional outreach to patients, but the manufacturer believed communicating with providers was sufficient. In another case, the agency thought a recalled device’s removal was more appropriate than the manufacturer’s proposal to modify its instructions.
While the FDA has some tools to address these disagreements, agency officials told the GAO that they would like the ability to require manufacturers to tailor their communications to different audiences. This authority would likely require more resources, FDA officials said in the report, although it could help eliminate lengthy back-and-forth communications with manufacturers in some cases.
Legislation introduced
Sen. Durbin and Rep. Jan Schakowsky, D-Ill., introduced legislation last week to improve the medical device recall process.
The bill, called the Medical Device Recall Improvement Act, would require the FDA to establish an electronic format for recall notifications and require manufacturers to send electronic recall notifications to the FDA, hospitals and providers. It would also require manufacturers to include information about how a recall could affect patients in their notices.
