The agency exceeded its three-month termination timeline for 74% of recalls during fiscal years 2020-2024, due to staff constraints that limited oversight activities, the report finds.
The US Food and Drug Administration (FDA) faces significant challenges in overseeing medical device recalls due to insufficient staffing and limited authority over manufacturer-initiated recall strategies, according to a new Government Accountability Office (GAO) report released in December.
The GAO analyzed 3,934 medical device recalls initiated between fiscal years 2020-2024 and found that FDA exceeded its three-month goal for terminating recalls in 74% of cases. The agency terminated class I recalls—the highest risk category—an average of 263 business days after completion, ranging from 11 to 882 days.
“Insufficient staff limit FDA’s ability to conduct oversight activities,” according to the report. The agency oversees approximately 900 medical device recalls annually, more than biologics and drug recalls combined.
Resource Constraints Impact Critical Activities
FDA’s Office of Inspections and Investigations (OII) officials told GAO they must process a large volume of medical device recalls with limited time, insufficient staffing levels, and information technology systems requiring extensive manual data entry, according to the report. As a result, the agency often forgoes important oversight activities including reviewing manufacturer recall status reports and conducting in-person recall audit checks.
“OII officials stated that the final stage of the recall process, recall termination, is on the ‘back burner’ due to limited resources,” the report says.
According to the report, stakeholders told the GAO that delays can affect patient care and create confusion for providers and the public, noting that extended recall timelines may lead patients to seek less helpful treatments or cause the public to believe manufacturers are not attempting to resolve recalls when they actually are.
Authority Limitations Create Inefficiencies
The report also highlights FDA’s limited authority over manufacturer-initiated recall strategies. Agency officials said they cannot require manufacturers to adopt FDA’s recommendations for how to carry out certain recalls, which can result in inefficient back-and-forth communications and potentially confusing information reaching healthcare providers and patients, according to the report.
“Some stakeholders said manufacturers and FDA communicating different information can be confusing,” the report states. “FDA officials said it can also result in inefficient use of resources.”
Recall Data Reveals Patterns
GAO’s analysis found that manufacturers identified 96% of the 3,934 medical device recalls reviewed, while FDA identified the remaining 4%. FDA did not mandate any recalls during the study period, although the agency has used its mandatory recall authority four times since Congress granted it in 1990. Those actions involved a defective wheelchair lift, a ventilating system, a feeding pump, and a disinfecting solution. According to the report, FDA has not ordered a mandatory medical device recall since 1992.
“FDA could use its mandatory recall authority and change the recall from manufacturer-initiated to mandatory, thereby giving FDA authority over the strategy. However, agency officials told us that using that authority would require them to follow the time- and resource-intensive multistep process …” the report reads.
Class II recalls accounted for 88% of all device recalls, while class I recalls represented 9% and class III recalls made up 3%. Seven medical specialty areas accounted for 75% of device recalls, with cardiology, orthopedics, and general and plastic surgery leading the categories.
FDA Initiatives Address Some Concerns
FDA has implemented several initiatives to improve transparency and communication. In November 2024, the agency launched a pilot program for “early alerts” on potentially high-risk device recalls in select specialty areas, including cardiovascular devices. The agency announced an expansion of the program in September 2025.
The agency also implemented a public enforcement report subscription system in 2022, allowing users to receive targeted recall updates based on keyword searches. Additionally, FDA proposed a two-year study on risk communication for medical device recalls in June 2022.
Recommendations for Improvement
GAO made two recommendations to the Department of Health and Human Services, under which FDA operates. The first calls for strategic workforce planning to determine staffing resources and skills needed for effective recall oversight. The second recommends assessing whether FDA needs additional legislative authority to require manufacturers to implement agency recommendations for recall strategies.
According to the report, HHS concurred with the workforce planning recommendation and said it would consider the authority assessment.
The report notes that FDA’s oversight of medical products has remained on GAO’s High-Risk List since 2009, partly because staffing and workforce challenges have been only partially addressed.
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