The United States Government Accountability Office (GAO) issued a report to the United States Congress in December 2025 entitled “HHS and FDA Should Address Limitations in Oversight of Recall Process” in which it stated:
From fiscal years 2020 to 2024, FDA oversaw the recall of 3,934 medical devices. All were voluntarily recalled by manufacturers. FDA can mandate a recall, although it rarely does so.
Insufficient staff limit FDA’s ability to conduct oversight activities, according to officials. For example, from fiscal years 2020 to 2024, FDA couldn’t meet its 3-month goal of terminating recalls (meaning FDA determines all reasonable efforts were made by the manufacturer to remove or correct the device) due to resource constraints. Some stakeholders said delays can affect patient care. The Department of Health and Human Services (HHS) oversees FDA and is currently undergoing reforms. Conducting workforce planning to determine the staffing and skills FDA needs for oversight would help HHS keep unsafe devices from continued use.
According to officials, FDA cannot require manufacturers to adopt its recommendations for how to carry out certain recalls. Some stakeholders said manufacturers and FDA communicating different information can be confusing. FDA officials said it can also result in inefficient use of resources. By working with FDA to assess if additional authorities are needed, and seeking them if beneficial, HHS may be better positioned to address current recall process inefficiencies.
According to the World Health Organization, there are an estimated 2 million medical devices on the world market. The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), currently oversees the safety of more than 190,000 distinct medical devices in use in the United States, an increase of about 15,000 since 2016. An integral part of patient care, medical devices include a wide range of products—from surgical masks to implantable pacemakers—intended to prevent, diagnose, cure, treat, or mitigate diseases or other conditions.
In almost every instance, the manufacturer voluntarily initiates a recall before FDA has to mandate one. There were no instances of FDA mandating a recall in the 5 years of data that the GAO analyzed (fiscal years 2020-2024). FDA has used its mandatory device recall authority four times since it received it in 1990. Specifically, FDA used the authority to recall a defective wheelchair lift, a ventilating system, a feeding pump, and a disinfecting solution. The agency has not mandated a device recall since 1992.
According to FDA officials, the agency faces several challenges in the device recall process. Three challenges affect the agency’s oversight of recalls. The first is the large number of recalls. In any given year, there are more device recalls than biologics and drug recalls combined. FDA’s publicly available data show that, in fiscal year 2024, there were 1,017 medical device recalls compared to 333 biologics recalls and 318 drug recalls. FDA OII officials explained that they must process a large volume of medical device recalls with limited time, insufficient staffing levels, and information technology database systems that require extensive manual data entry.
The second challenge to its oversight, according to FDA officials, is the scope of medical devices, which is vast, and often includes rapid improvements and continuous enhancements compared to biologics and drugs. According to officials, this means that overseeing medical device recalls can be more complex and more challenging compared to recalls for drugs or biologics. For example, devices include physical products, such as catheters or defibrillators, or nonphysical products, such as predictive or diagnostic software. A single device also can be a combination of both. As such, a recall may involve a correction or removal of a single device, or one or multiple components of a single device.
Finally, FDA OII officials often do not have sufficient staff to conduct necessary medical device recall oversight activities. According to officials, examples of important oversight activities not conducted include reviewing manufacturer Recall Status Reports and conducting in-person recall 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). Furthermore, OII officials stated that the final stage of the recall process, recall termination, is on the “back burner” due to limited resources. This was confirmed by an analysis of FDA data, which found that 74 percent of recalls across fiscal years 2020-2024 exceeded FDA’s policy of terminating a recall within 3 months of receiving the manufacturer’s request to terminate.
If a device is found to be defective or unsafe once in use, the ramifications can be severe, potentially resulting in permanent injury or death to the individual using the device. A recall—the removal or correction of a medical device—is an important process overseen by FDA to ensure the agency’s effectiveness in mitigating serious health consequences associated with defective or unsafe medical devices. There were about 900 recalls initiated by device manufacturers and overseen by FDA in each of the past 5 years, according to FDA’s publicly available data.
If you or a loved one suffered serious harm (or worse) as a result of a defective medical device in the United States, you should promptly find a defective medical device lawyer in your state who may investigate your medical device claim for you and represent you or your loved one in a defective medical device case, if appropriate.
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