A critical performance audit from the U.S. Government Accountability Office (GAO) has revealed that persistent and severe understaffing within the Food and Drug Administration (FDA) is critically undermining the agency’s ability to oversee medical device recalls, leading to dangerous delays that jeopardize public health. The exhaustive 18-month investigation, which was initiated following requests from U.S. senators, paints a stark picture of an agency struggling to keep pace with the rapidly evolving medical technology landscape. The report concludes that chronic staffing shortages are forcing the FDA to sideline essential oversight activities, creating a reactive system where crucial follow-up actions are consistently deferred. This operational strain results in a prolonged response to faulty devices, leaving patients and healthcare providers in a state of uncertainty and potential risk long after a safety issue has been identified and supposedly addressed by a manufacturer.
A System Overwhelmed by Triage
The core issue identified by the GAO is the fundamental inadequacy of the FDA’s workforce to manage the sheer volume and complexity of its regulatory duties. Officials from the agency’s Office of Inspections and Investigations explicitly informed auditors that vital tasks are being systematically neglected to free up limited personnel for what are considered the most immediate threats. This constant state of triage means that fundamental oversight functions are sacrificed. Among the activities consistently placed on the “back burner” are the thorough reviews of manufacturer status reports, which are essential for tracking the progress of a recall, and the execution of in-person audit checks designed to verify that a company is effectively removing or correcting a dangerous device from the market. These crucial follow-up and verification steps are often deferred indefinitely or abandoned entirely so that the agency can focus its scarce resources on the highest-risk Class I recalls and the very initial stages of the recall process, such as initiation and classification.
This pervasive operational strain is most glaringly evident in the final, critical stage of the recall process, officially known as “recall termination.” This is the point at which the FDA confirms that a manufacturer has completed all necessary corrective actions and formally closes the case, providing a clear signal to the public that the safety issue has been resolved. While the FDA’s internal policy aims to complete this termination process within 90 business days of a manufacturer finishing its work, the GAO discovered a profoundly different reality. On average, the agency takes approximately 260 days to terminate a recall. This significant delay has serious consequences, as it can sow considerable confusion among healthcare providers and patients. A medical device that remains in an “ongoing” recall status long after being fixed can lead to the incorrect assumption that a safety issue persists, potentially disrupting patient care, eroding trust, and creating unnecessary logistical burdens for hospitals and clinics. The scale of this backlog is staggering: of the 3,934 recalls initiated between fiscal years 2020 and 2024, an overwhelming 62% were still officially listed as ongoing at the time of the GAO’s review.
The Vast Scope and Human Cost of Delays
The GAO report contextualizes these staffing challenges by emphasizing the unique and daunting complexities of the modern medical device market. With nearly 200,000 distinct devices available to patients, the scope of oversight is immense and far more intricate than for pharmaceuticals. This landscape includes not only physical hardware like pacemakers, artificial joints, and surgical instruments but also an ever-growing array of intangible yet critical products such as diagnostic software and sophisticated artificial intelligence algorithms. This inherent complexity contributes to a significantly higher frequency of recalls. The FDA typically handles between 900 and 1,000 medical device recalls annually, a figure that dwarfs the roughly 300 recalls seen each for drugs and biologics. An analysis of nearly 4,000 recalls from 2020 to 2024 revealed that while manufacturers self-identify the safety issue in the vast majority of cases (96%), the FDA’s vigilance was responsible for identifying non-compliance and compelling the company to act in the remaining 145 cases, underscoring the indispensable role of the agency’s proactive oversight.
To underscore the grave, real-world implications of these systemic failures, the GAO report highlighted the high-profile recall of Philips’ CPAP and BiPAP machines. This case, which spanned several years and culminated in multimillion-dollar legal settlements, served as a stark example of a safety issue escalating under intense media scrutiny and litigation while the regulatory process faltered. The GAO noted that the FDA’s own data indicated it had received over 500 reports of deaths potentially associated with the degrading foam in the sleep apnea machines from 2021 until the product was finally removed from the market in 2024. An analysis of recall data from the audited period showed that the most serious risk category, Class I, where a device poses a risk of serious injury or death, accounted for approximately 9% of all recalls. While the fields of cardiology, orthopedics, and general surgery saw the most recalls overall, it was the specialty of anesthesiology—which includes critical devices like ventilators and epidural kits—that recorded the highest number of life-threatening Class I recalls, with a total of 93.
A Path Forward Through Reform and Resources
In light of these critical deficiencies, the Government Accountability Office issued two key recommendations aimed at rectifying the FDA’s operational weaknesses. Firstly, it strongly urged the Department of Health and Human Services (HHS), the FDA’s parent agency, to conduct a thorough and strategic workforce planning assessment. This would ensure the FDA is equipped with the necessary number of staff, the appropriate skills, and the essential resources to effectively and efficiently manage its medical device recall responsibilities now and in the future. Secondly, the GAO recommended that the FDA and HHS explore seeking additional legal authority from Congress to strengthen the agency’s enforcement capabilities. Although the FDA technically possesses the power to mandate a recall, this authority has been used so rarely—only four times, all in the early 1990s—that it is practically non-existent in the modern regulatory environment. Consequently, virtually all recalls are initiated voluntarily by the manufacturer. The GAO suggested the FDA could benefit immensely from the power to compel companies to follow its specific recommendations during these voluntary recalls. In response, HHS concurred with the workforce planning recommendation and agreed to consider the suggestion for enhanced legislative authority.
The report also chronicled a history of unsuccessful efforts to resolve the agency’s deep-rooted staffing crisis. A promising initiative to hire more dedicated recall staff in late 2023 was reportedly halted by a federal hiring freeze. Moreover, a comprehensive workforce strategy document that had been developed to guide the agency through the 2027 fiscal year was described by FDA officials in early 2025 as being “obsolete.” This was compounded by a major departmental reorganization at HHS in March 2025, which included reductions in force that further impacted the FDA. Despite these significant institutional changes, the GAO found that the agency had not conducted a new, updated assessment to determine the precise number of staff and the specific skills needed to meet its current and future oversight obligations. Amid these persistent challenges, the audit did acknowledge a positive step taken by the FDA. In November 2024, the agency launched a pilot program for early recall alerts on high-risk devices, a system that allowed it to inform the public about a potential issue much faster, even before an official risk classification had been assigned, thereby shortening the time it took for crucial safety information to reach patients and providers.
