GAO Flags Staffing Gaps and Legal Limits With Device Recalls

The Government Accountability Office (GAO) is urging HHS to shore up staffing and reassess legal authorities at FDA after finding significant weaknesses in how the agency oversees medical device recalls, including lengthy delays in formally closing recalls of high-risk products.

In a just-released report, GAO found that FDA oversaw 3,934 medical device recalls between fiscal years 2020 and 2024 — all initiated voluntarily by manufacturers — and struggled to meet its own timeliness goals because of staffing shortages, device complexity, and limits on its authority over manufacturer-led recall strategies. FDA’s oversight of medical products has been on GAO’s high-risk list since 2009.

“Effectively managing and overseeing recalls of medical devices through all phases is vitally important to public health,” GAO wrote, noting that defective devices such as ventilators, insulin pumps, or pacemakers can cause serious injury or death if problems are not promptly addressed.

Under FDA policy, recalls should be terminated within three months after a manufacturer reports that corrective actions are complete. GAO’s analysis found that the agency routinely misses that goal. Of the 3,934 recalls initiated during the five-year period, only 1,408 had been terminated at the time of GAO’s review, and 74% of those took longer than 90 business days to close.

Medical devices accounted for more recalls than drugs and biologics combined during the period studied. In fiscal year 2024 alone, FDA logged 1,017 device recalls, compared with 333 biologics recalls and 318 drug recalls.

GAO said oversight is complicated by the breadth and technical complexity of modern devices, many of which combine hardware and software components and undergo frequent updates. Insulin pumps, for example, may require recalls involving software corrections, physical device replacement, or both.

FDA officials acknowledged to GAO that staffing levels are insufficient to conduct key oversight tasks, including reviewing manufacturers’ recall status reports and performing in-person audit checks. Although the agency reorganized recall staff in late 2024 and attempted to hire additional personnel, a federal hiring freeze in early 2025 prevented those positions from being filled.

GAO noted that FDA considers its existing workforce plans obsolete following a broader HHS reorganization announced in March, which aims to streamline operations and reduce costs and could result in workforce reductions at the agency.

The government watchdog also highlighted limits on FDA’s authority in manufacturer-initiated recalls, which make up the vast majority of device recalls. While FDA can recommend recall strategies — such as the scope of communications or whether devices should be removed rather than relabeled — it generally cannot require manufacturers to follow those recommendations.

GAO said this can lead to inconsistent messaging between FDA and manufacturers, inefficient back-and-forth negotiations, and confusion among providers and patients. Although FDA can issue its own safety communications or pursue a mandatory recall, officials told GAO that mandatory recalls are rare and require a time- and resource-intensive process.

FDA has not assessed whether it needs additional legislative authority to require manufacturers to adopt agency-recommended recall strategies, GAO said, nor has it asked Congress for such authority.

GAO acknowledged steps FDA has taken to improve transparency and communication, including a pilot program launched in late 2024 to issue “early alerts” for potentially high-risk device recalls, and ongoing research into best practices for risk communication. Still, most stakeholders interviewed by GAO cited ongoing concerns about transparency, particularly around recall classification decisions and diminished communication during the termination phase.

GAO made two formal recommendations to HHS: work with FDA to conduct strategic workforce planning to determine the staffing and skills needed to oversee device recalls effectively, and assess whether FDA needs additional legislative authority over manufacturer-initiated recall strategies and seek it if warranted. HHS concurred with the workforce planning recommendation and said it would take the question of additional authority under consideration as part of its restructuring efforts.

Without those steps, GAO warned, FDA may continue to struggle to meet recall timeliness goals, leaving unsafe or defective devices in use longer than necessary and prolonging uncertainty for patients and providers.