FDA Medical Device Recall Oversight Under Scrutiny as GAO Finds Staffing Shortages May Put Patients at Risk

Nearly 4,000 Device Recalls Between 2020 and 2024 Highlight Safety Risks and Accountability Issues

Medical devices are used every day in hospitals, surgical centers, and outpatient clinics across the United States. From infusion pumps and ventilators to implants and diagnostic equipment, these devices play a direct role in sustaining life, diagnosing disease, and delivering treatment. When a medical device fails or contains a defect, the consequences can be severe and sometimes fatal.

What Parker Waichman LLP Found

• Nearly 4,000 medical devices were recalled in the United States between 2020 and 2024.
• The FDA lacks sufficient staff to fully monitor recall activities.
• Most device recalls are voluntary and initiated by manufacturers.
• Delays in recall oversight may allow dangerous devices to remain in use longer.
• Patients harmed by defective medical devices may have the right to file a lawsuit.

A recent report issued by the U.S. Government Accountability Office has raised serious concerns about how medical device recalls are handled in the United States. The watchdog agency found that the U.S. Food and Drug Administration does not currently have enough staff or authority to effectively oversee the growing number of device recalls.

Between fiscal years 2020 and 2024, 3,934 medical devices were recalled in the United States. During that same time period, the FDA struggled to keep pace with the administrative work required to monitor and close these recalls. Federal officials acknowledged that staffing shortages have slowed oversight activities and may leave dangerous devices in circulation longer than intended.

For patients and families who rely on medical devices for treatment, these findings raise troubling questions. If regulatory agencies cannot adequately supervise recalls, defective devices may continue to be used in hospitals or homes even after safety concerns are identified.

When injuries occur because of unsafe devices, manufacturers may be held legally responsible for the harm caused.

What the Government Accountability Office Found

The Government Accountability Office conducted a detailed review of the medical device recall process and the FDA’s ability to manage those recalls. The findings point to structural challenges that have persisted for years.

One of the most significant issues is insufficient staffing within the FDA’s device recall oversight programs. According to the report, there are not enough employees to perform essential monitoring functions such as reviewing recall reports submitted by manufacturers and conducting on-site audit inspections.

FDA officials explained that they must prioritize the most urgent recalls due to limited resources. As a result, certain steps in the recall process — particularly the final phase known as recall termination — are often delayed.

The FDA has a goal of closing recalls within three months after corrective actions are completed. However, staffing shortages frequently prevent the agency from meeting this target.

The GAO warned that these delays can create inefficiencies and may increase the risk to patients if defective products remain in use.

The watchdog agency also noted that the FDA currently lacks comprehensive data regarding how many employees are actually required to effectively oversee recall activity nationwide.

Nearly 4,000 Devices Recalled in Just Four Years

The scale of the problem becomes clearer when examining the number of recalled devices.

From 2020 through 2024, the FDA recorded 3,934 medical device recalls in the United States. In fiscal year 2024 alone, there were 1,017 recalls involving medical devices.

Medical device recalls occur for many reasons, including:

• Software failures
• Mechanical defects
• Sterility issues
• Electrical malfunctions
• Incorrect labeling or instructions
• Component failures
• Manufacturing errors

Unlike pharmaceuticals, medical devices often involve both hardware and software components, making recall investigations more complex. A device may require replacement parts, software updates, or removal from use entirely.

The large volume of recalls combined with the technical complexity of devices places significant pressure on regulators responsible for overseeing safety corrections.

When oversight resources are limited, there is a greater risk that problems may persist longer than expected.

Staffing Shortages and Hiring Freezes

The GAO report also highlights workforce challenges affecting federal oversight programs.

The FDA’s Office of Inspections and Investigations (OII) is responsible for recall coordination, enforcement actions, and inspections involving medical products. In 2024, the office reorganized its structure and moved recall coordinators into a centralized branch in an effort to improve efficiency.

The agency also attempted to expand its recall oversight team by hiring additional staff. However, those efforts were disrupted by a federal hiring freeze that began in early 2025.

Without the ability to fill these positions, recall monitoring responsibilities remain concentrated among a limited number of employees.

The situation could become more difficult due to broader workforce reductions across the Department of Health and Human Services. Proposed cuts have included thousands of positions across the department, including employees supporting the FDA’s inspection and regulatory activities.

These reductions may further strain the agency’s ability to monitor medical device safety nationwide.

Most Medical Device Recalls Are Voluntary

Another key issue identified in the report involves the FDA’s authority during recall situations.

Although the agency technically has the power to mandate medical device recalls, that authority is rarely used. The process required to order a mandatory recall involves multiple legal steps and can take significant time to complete.

Since receiving this authority in 1990, the FDA has exercised it only four times.

As a result, the overwhelming majority of device recalls are voluntary actions initiated by manufacturers themselves.

In many cases, companies identify problems during internal safety reviews or after receiving reports of device malfunctions from hospitals or patients. They then notify the FDA and begin a voluntary recall.

While voluntary recalls can resolve safety concerns quickly, they may also create disputes when regulators disagree with a manufacturer’s approach to notifying the public or correcting the problem.

Disagreements Between the FDA and Device Manufacturers

The GAO report documented several situations where the FDA and manufacturers disagreed about how a recall should be handled.

In one case, the FDA believed the public should receive a press notification about a recall. The manufacturer disagreed and preferred to limit communication to healthcare providers. Ultimately, the agency issued its own safety communication to inform the public.

In another situation, regulators believed that a recalled device should be removed entirely from the market. The manufacturer instead proposed revising instructions for use.

These disagreements can slow the recall process and delay corrective action.

FDA officials indicated that they would benefit from greater authority to require manufacturers to follow specific communication strategies when notifying patients and healthcare providers about safety risks.

However, expanding that authority would likely require new legislation and additional resources.

New Legislation Aims to Improve Recall Notifications

In response to ongoing concerns about recall oversight, lawmakers have introduced legislation intended to strengthen the medical device recall process.

Senator Richard Durbin and Representative Jan Schakowsky introduced the Medical Device Recall Improvement Act, which would modernize recall notification systems and improve communication between manufacturers, regulators, and healthcare providers.

The bill proposes several changes, including:

• Establishing an electronic format for recall notifications
• Requiring manufacturers to send electronic recall notices to hospitals and healthcare providers
• Ensuring that recall notices clearly explain how patients may be affected

These reforms are intended to speed up the recall process and provide clearer information to healthcare providers and patients when safety issues arise.

Legal Rights for Patients Injured by Defective Medical Devices

When a defective medical device causes injury, affected individuals may have the right to pursue compensation through a product liability lawsuit.

Manufacturers have a legal obligation to ensure that medical devices are reasonably safe when used as intended. This duty includes proper testing, accurate labeling, adequate warnings, and responsible monitoring after a device reaches the market.

If a company fails to address safety concerns in a timely manner, injured patients may pursue legal claims seeking compensation for:

• Medical expenses
• Lost wages
• Long-term treatment costs
• Pain and suffering
• Permanent disability

These cases often involve complex evidence, including device design records, internal company documents, adverse event reports, and regulatory communications.

Legal claims also help uncover whether manufacturers responded appropriately when early safety signals appeared.

Lawsuit FAQs

What is a medical device recall?
A medical device recall occurs when a manufacturer or the FDA identifies a problem that could affect patient safety. Recalls may involve correcting the device, updating instructions, replacing components, or removing the product from the market.

Can I file a lawsuit if a recalled medical device injured me?
Yes. If a defective device caused injury or worsened a medical condition, you may have the right to file a product liability claim against the manufacturer or other responsible parties.

Do I need proof that the device was recalled?
A recall can strengthen a claim, but it is not always required. Many lawsuits are filed before an official recall occurs if evidence shows that a device was unsafe.

What compensation may be available?
Victims may recover compensation for medical bills, rehabilitation costs, lost income, reduced earning capacity, and pain and suffering. Severe injuries may also involve long-term care costs.

How long do I have to file a lawsuit?
The deadline to file a claim depends on state law. These deadlines, known as statutes of limitations, vary across the country. Acting quickly helps preserve evidence and protect legal rights.

What evidence is used in a medical device case?
Evidence may include medical records, device serial numbers, hospital records, FDA reports, engineering data, and internal communications from manufacturers.

Do these cases involve large manufacturers?
Many medical device lawsuits involve multinational corporations that design, manufacture, and distribute medical technology worldwide.

Contact Parker Waichman LLP For a Free Case Review

Defective medical devices can cause serious and life-changing injuries. When manufacturers fail to address safety risks or warn patients about potential dangers, injured individuals deserve answers and accountability.

Parker Waichman LLP represents victims nationwide who were harmed by defective medical devices. The firm offers free case evaluations to help individuals understand their legal rights and determine whether they may qualify to file a lawsuit.

If you or a loved one suffered injuries related to a recalled medical device, call 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.