FDA Recall Bottlenecks: GAO Report Highlights Staffing Gaps and Oversight Delays

FDA Recall Bottlenecks: GAO Report Highlights Staffing Gaps and Oversight Delays

A recent report from the US Government Accountability Office (GAO) has sounded the alarm on the FDA's ability to oversee medical device recalls. Staffing shortages and a growing volume of complex products, including AI-enabled software, have pushed critical safety work to the "back burner."

Key Findings from the GAO Report

The investigation identifies several systemic issues that could leave patient safety gaps unresolved for months:

1. Severe Delays in Recall Terminations

While the FDA's internal policy targets 90 business days to formally close a recall once a fix is completed, the current average has ballooned to approximately 260 days. Between 2020 and 2024, 62% of recalls remained listed as "ongoing," creating significant confusion for clinicians and patients regarding which devices are safe to use.

2. Resource Shifting to High-Risk Cases

Due to limited personnel, the FDA often shifts staff to focus exclusively on Class I recalls—those with the highest risk of serious injury or death. As a consequence, oversight for lower-risk recalls and essential close-out administrative steps are frequently delayed or skipped entirely.

3. Complexity of Medtech vs. Pharma

The medical device market is significantly more difficult to monitor than the pharmaceutical sector. With nearly 200,000 devices on the market, device recalls are both more frequent and technically complex. The FDA oversees approximately 1,000 device recalls per year, compared to roughly 300 in the pharmaceutical industry.

4. Reliance on Voluntary Actions

Despite having the legal power to mandate recalls, the FDA has only used this authority four times since the early 1990s. Currently, 96% of all recalls are initiated voluntarily by manufacturers.

The Impact of a Hiring Freeze

The FDA's attempt to bolster its workforce in late 2024 was thwarted by a federal hiring freeze. Previous workforce plans are now considered obsolete, leaving the agency with a team that lacks the modern skills required to manage digital and iterative device innovations.

Strategic Recommendations

The GAO has urged the FDA and the Department of Health and Human Services (HHS) to implement structural fixes, including:

• Strategic Workforce Planning: Assessing the specific skills needed for modern medtech oversight.
• Legal Authority: Considering stronger legal mechanisms to compel manufacturer actions during voluntary recalls.
• Modernized Closure Mechanisms: Streamlining the process to ensure recalls are terminated promptly once the risk is mitigated.

As medical devices become increasingly driven by software and AI, the GAO emphasizes that oversight capacity must accelerate to keep pace with innovation. Transparency alone is insufficient; effective execution is required to maintain public trust in device safety.