GAO Report Reveals FDA Staffing Shortages Delay Medical Device Recalls, Raising Safety for Injured Patients

FDA Delays Could Put Lives at Risk

The safety of medical devices in the United States depends heavily on the timely actions of the U.S. Food and Drug Administration (FDA). When a product poses a threat to patient health, swift recalls and public alerts are essential to prevent further injuries or deaths. However, a newly released Government Accountability Office (GAO) report reveals a troubling reality: the FDA is falling behind on its medical device recall responsibilities due to staffing shortages and outdated oversight processes.

This failure in the regulatory system has real-world consequences. Many dangerous or defective devices remain in clinical use or consumer circulation far longer than they should. Some recalls take months to finalize, while others linger in bureaucratic limbo, creating confusion and exposing patients to preventable harm. From CPAP machines linked to hundreds of deaths to anesthesiology tools under Class I recalls, the need for reform is growing more urgent.

The GAO Report: A Deep Review of the FDA’s Shortcomings

At the request of U.S. lawmakers, the GAO conducted an 18-month audit to evaluate how the FDA handles recalls for medical devices. The audit focused on nearly 4,000 recalls between fiscal years 2020 and 2024. One of the most alarming findings was that 62% of these recalls were still ongoing, meaning the FDA had not formally closed the cases, despite manufacturers claiming they had corrected the issues.

In addition, the average time for the FDA to “terminate” or officially close a recall far exceeds its own goal. While the agency’s policy sets a benchmark of 90 business days, the actual average is closer to 260 days, nearly three times longer than intended.

The GAO attributes this failure primarily to staffing constraints, worsened by a federal hiring freeze and lack of updated workforce planning. Critical follow-up tasks, such as auditing compliance reports and performing in-person inspections, have been put on hold while FDA officials redirect resources to the most severe cases.

Voluntary Recalls Dominating the System

Another major concern highlighted by the report is the FDA’s overreliance on voluntary recalls. Although the agency has legal authority to mandate a recall, it has done so only four times in its history, and all those cases occurred more than two decades ago. Instead, 96% of device recalls from 2020 to 2024 were initiated by the manufacturers themselves.

While voluntary cooperation may sound productive, it puts the power in the hands of companies, some of which may prioritize profit over public safety. The GAO recommended that the Department of Health and Human Services (HHS) and the FDA consider requesting expanded legal authority to compel companies to comply with agency recommendations during a recall process.

Impact on Patient Safety and Legal Accountability

The FDA’s failure to follow through on thousands of open recalls could have serious effects on patient care. Patients and healthcare providers may continue using devices they assume are safe, simply because the recall has not been officially closed. This miscommunication opens the door to delayed treatment, unnecessary harm, and even death.

One example cited in the GAO report is the Philips CPAP recall, which affected millions of sleep apnea patients and resulted in over 500 reported deaths before the product was removed in 2024. Lawsuits stemming from that recall have led to significant settlements. This case illustrates what can happen when oversight is delayed or incomplete.

Moreover, injuries from recalled devices may include:

• Permanent disability due to malfunctioning orthopedic implants.
• Cardiac complications caused by faulty pacemakers or heart monitors.
• Infections or surgical injuries from improperly sterilized tools.
• Brain injuries from faulty ventilators or anesthesia delivery systems.

Which Devices Are Most Often Recalled?

According to the GAO findings, certain specialties saw more recalls than others. From 2020 to 2024, the three categories with the highest number of recalls were:

1. Cardiology
2. Orthopedics
3. General and Plastic Surgery

However, when it came to Class I recalls — the FDA’s most serious classification for products that pose immediate danger of injury or death — the field of Anesthesiology had the highest count with 93 recalls. These included ventilators, epidural kits, and other life-critical devices.

With approximately 900 to 1,000 medical device recalls per year, the FDA is tasked with monitoring a rapidly growing market of more than 200,000 individual devices — from hardware and surgical tools to AI-enabled diagnostic software. Unlike pharmaceuticals, which average around 300 recalls annually, medical devices involve far more frequent and diverse safety issues.

Problems with Recall Termination

One of the most overlooked areas of the FDA’s process is the final phase known as recall termination. This is when the agency publicly confirms that a manufacturer has completed all necessary steps to fix or remove the defective product. Unfortunately, the GAO report shows that the agency has largely deprioritized this step due to staffing shortages.

Without official termination, healthcare providers and patients may be left wondering whether a product remains unsafe. Inconsistent communication, lack of closure, and incomplete status updates all undermine the trust consumers place in regulatory agencies. As a result, patients harmed by recalled devices may not even realize that their injuries could have been prevented.

FDA’s Attempted Reforms and Challenges

To its credit, the FDA has acknowledged the problem. The agency began a pilot program in late 2024 aimed at issuing early warnings for high-risk recalls. In one example, the FDA issued a public alert just three days after a manufacturer warned hospitals about a dangerous device. But this quick action remains the exception, not the rule.

Further attempts to hire recall-focused staff were derailed by a federal hiring freeze initiated by the Trump administration in early 2025. Although the FDA once had a workforce strategy planned through 2027, officials now say those plans are outdated and no longer applicable following recent reorganizations at the HHS level.

The GAO has urged HHS to develop a new staffing assessment and long-term hiring plan to ensure the FDA has enough qualified personnel to oversee the entire lifecycle of a recall — from initial identification to final resolution.

What Patients and Families Need to Know

For patients, the GAO’s report is a wake-up call. If you or a loved one suffered an injury linked to a recalled device, especially one that remained in use for months despite known risks, you may have grounds for legal action. These are not isolated incidents. The failures described in the report reflect a system-wide problem in how medical device safety is managed in the United States.

Even if a recall is eventually issued, the delay can make injuries worse. Some patients undergo repeat surgeries. Others experience chronic pain or loss of organ function. Families of deceased patients are left searching for answers that may never come from the FDA or the manufacturer alone.

Legal action may provide a path to compensation and accountability. It can also shine a spotlight on practices that need to change — ensuring other families don’t experience similar harm.

FAQs About Medical Device Recalls and Legal Options (400 Words)

What is a medical device recall?
A medical device recall is a process in which a product is corrected or removed from use due to defects that pose a risk to patient safety. Recalls can be voluntary (initiated by the manufacturer) or mandated by the FDA.

Why are so many recalls still ongoing?
The FDA has not completed the final steps to formally close most recalls. Staffing shortages, especially in the Office of Inspections and Investigations, have caused delays in follow-up activities and recall terminations.

What types of devices are most often recalled?
Cardiology, orthopedics, and surgical tools are among the most recalled categories. High-risk Class I recalls are especially frequent in anesthesiology devices such as ventilators.

Can I file a lawsuit if I was injured by a recalled device?
Yes. If you were harmed by a defective device, especially one that remained in use after a recall was issued or delayed, you may be eligible to file a personal injury claim or wrongful death lawsuit.

What damages can I recover?
Victims may be entitled to compensation for medical bills, lost income, pain and suffering, long-term disability, and loss of companionship in fatal cases.

How do I know if a device I used was recalled?
You can search the FDA’s recall database or consult with a medical professional. An attorney can also help determine if the product involved in your care was subject to a safety alert or recall.

Is there a time limit to file a lawsuit?
Yes. Every state has statutes of limitations that restrict how long you have to file a claim. An attorney can help you determine how much time you have based on your case and location.

Does the FDA help victims financially?
No. The FDA does not provide compensation. Legal claims must be filed through the civil court system, typically against the manufacturer or others involved in distributing the faulty device.

Contact Parker Waichman LLP For A Free Case Review

If you or someone you love was harmed by a defective or recalled medical device, you may be eligible for significant compensation. The national law firm Parker Waichman LLP is reviewing claims related to FDA recall delays and medical device injuries.

Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free consultation. Don’t wait. Important legal deadlines may apply, and your case deserves immediate attention. Let Parker Waichman LLP help you hold negligent companies accountable and fight for the justice you and your family deserve. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.