The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be placed on the “back burner” and resulting in lengthy response times, according to a new report from the U.S. Government Accountability Office (GAO).
The GAO published its findings this week after an 18-month-long performance audit of the agency conducted at the request of U.S. senators. In its report, the GAO cited Philips’ major recall of CPAP machines, which spanned years and led to multimillion-dollar settlements, as an example of a safety issue that was subject to high-profile media attention and litigation.
“For example, FDA indicated on its website that it had received over 500 reports of deaths associated with the CPAP machine since 2021 prior to it being removed from the market in 2024. Our past work found similar issues relating to recalls,” the GAO wrote in its report.
The congressional watchdog agency said that while the FDA is taking steps to address recall challenges, it has not thoroughly assessed how many staff members are necessary to complete the job. It also recommended that the agency and the Department of Health and Human Services (HHS) consider requesting additional legal authority to compel companies to recall their devices.
While the FDA currently has the power to institute a mandatory recall of a medical device or diagnostic test, it has rarely exercised it—only doing so four times, and all in the early 1990s. Virtually all recalls are conducted voluntarily by the manufacturer.
The GAO examined nearly 4,000 recalls spanning the fiscal years from 2020 to 2024, finding that 96% of the time, safety issues are first identified by the recalling manufacturer. In the remaining 145 recalls, the FDA found that a device was out of compliance with federal regulations, leading its maker to either pull its product from the market or fix the issue.
With nearly 200,000 distinct medical devices on the market today—ranging from frequently updated physical hardware to intangible software and artificial intelligence, or any combination of the above—medtech recalls can be more challenging than recalls of pharmaceuticals. They’re also more frequent, with about 900 to 1,000 device recalls per year compared to about 300 each of drugs and biologics.
“FDA faces several challenges in the medical device recall process, including staff constraints for the large number and scope of medical device recalls, according to officials,” the GAO wrote.
“FDA is taking steps to address transparency and communication challenges described by stakeholders and the literature we reviewed. However, FDA has not conducted new workforce planning to determine what staffing resources and skills it needs to effectively carry out its responsibilities in light of ongoing departmental reform changes,” it added.
The GAO said officials in the FDA’s Office of Inspections and Investigations described how certain oversight activities are not being performed, such as reviewing manufacturer status reports and conducting in-person audit checks.
“Officials said they often forgo these activities because they must shift staff’s priorities to focus on the highest risk recalls (class I) and on the earlier stages of the recall process (initiation and classification),” the report said.
Additionally, the last steps of officially closing out recalls have been put on the “back burner” in recent years. Known as recall terminations, they mark the point where the FDA publicly concludes a manufacturer has completed all reasonable efforts to remove or correct a device.
Under agency policy, regulators have a 90-business-day goal to terminate a recall after the manufacturer finishes its work. On average, it can take about 260 days.
These delays can potentially cause confusion in patient care by suggesting there may still be a problem with a device after it has been remedied. Of the 3,934 recalls launched from fiscal years 2020 through 2024, the GAO found 62% listed as ongoing.
The FDA’s most serious risk category, Class I, accounted for about 9% of the recalls during the span. The vast majority were classified as Class II with moderate risk. Overall, the three medical specialties with the most recalls were cardiology, orthopedics and general and plastic surgery, while anesthesiology—including ventilators and epidural kits—logged the highest number of Class I recalls at 93.
The report also highlighted the FDA’s pilot program for early recall alerts in high-risk devices, launched in November 2024, where the agency informs the public of an issue before assigning an official risk classification. In one example, the agency got the word out just three days after the manufacturer issued its own advisory to healthcare providers.
The GAO said the FDA had attempted to hire more dedicated recall staff late last year but was stopped by the federal hiring freeze instituted by the Trump administration shortly after the president took office.
The report also said that the FDA previously issued an agencywide workforce strategy, looking out to the 2027 fiscal year, which included plans for staffing the inspections office and the Center for Devices and Radiological Health. “However, in early 2025, FDA officials told us that the agency now considers those plans obsolete,” the GAO wrote.
The HHS launched a major reorganization of its department in March, including reductions in force at the FDA. “However, FDA officials have not done a new assessment of workforce needs and have not determined the number of staff and the skills needed to meet their current and future oversight needs to effectively manage medical device recalls.”
The GAO recommended the HHS undertake more strategic workforce planning to ensure the FDA has the head count it needs to perform its recall oversight and that unsafe devices are taken off the market. The HHS concurred with the recommendation.
The office also suggested the FDA explore whether it would benefit from additional legislative authority, enabling it to require manufacturers to implement the agency’s recommendations during a voluntary recall. The HHS said it will consider it.