Medical devices play a critical role in patient care. They range from simple tools like bandages and blood pressure monitors to more complex technologies such as pacemakers and insulin pumps, used to prevent, diagnose, or treat disease. Some restore or support the body’s function, including orthopedic joint replacements. However, when products used for medical treatment turn out to be defective, the consequences can be life-altering, sometimes leading to other injuries, long-term health complications, or even death.
When everyday consumer products, such as children’s items, food, or household goods, are found to be unsafe, recalls are typically issued to alert the public and remove them from use. Medical device recalls present a more complex challenge, particularly when devices are implanted, such as knee or hip replacements, or used for ongoing treatment and cannot simply be removed or stopped without medical risk.
An example of this can be seen in the recall of CPAP machines a few years ago, which drew national attention to how dangerous medical devices are identified and removed from the market. Concerns about how long the CPAP defects may have gone unaddressed and the widespread litigation that followed led to a federal report raising new questions about how effectively the medical device recall system works and whether regulators are doing enough to protect patients.
Federal Report Finds FDA Seldom Uses Mandatory Recall Authority
A December 2025 report from the Government Accountability Office (GAO) found that the U.S. Food and Drug Administration (FDA) rarely uses its authority to force manufacturers to withdraw dangerous medical devices from the market, even in situations involving potentially dangerous products.
According to the report, the FDA has ordered a mandatory recall only four times since 1990, when it received the authority to do so, and they have not mandated a device recall since 1992. Instead, the agency relies overwhelmingly on manufacturers to voluntarily recall their devices after identifying safety concerns.
The GAO noted that the FDA relies heavily on voluntary recalls for several reasons, including staffing limitations, slow administrative processes, and the growing complexity of the medical device market. With thousands of devices entering the market each year, regulators face significant challenges in monitoring safety issues and responding quickly when problems arise.
Public health advocates have raised concerns that relying on voluntary action may delay the removal of unsafe products, potentially leaving patients exposed to harm longer than necessary.
Changes Recommended to Strengthen Medical Device Recalls
The GAO report also included recommendations to improve the handling of medical device recalls.
First, it urged the Department of Health and Human Services (HHS) to work with the FDA to conduct strategic workforce planning. The goal is to ensure the agency has enough staff, expertise, and resources to oversee recalls effectively, including performing audit checks and closing recalls within established timelines.
Second, the GAO recommended that HHS evaluate whether the FDA needs additional legal authority to require manufacturers to follow the agency's recommendations during recalls. Currently, the FDA often must rely on companies to voluntarily implement recall strategies, which may vary in speed and effectiveness.
These recommendations reflect broader concerns that the current system may not be equipped to keep pace with the rapidly evolving medical device industry.
How Medical Device Recalls Typically Work
In most cases, the medical device recall process begins with the manufacturer and not the FDA. Companies may initiate a recall after discovering a defect through internal testing, consumer complaints, adverse event reports, or post-market surveillance.
Once a potential issue is identified, the manufacturer typically notifies the FDA and proposes a recall plan. The agency then evaluates the risk and classifies the recall based on severity:
- Class I Recall: High risk of serious injury or death
- Class II Recall: Temporary or medically reversible harm
- Class III Recall: Low risk of harm
The recall process may involve removing the product from the market, issuing safety warnings, correcting the device, or providing updated instructions for use. In some cases, patients and healthcare providers are notified directly.
Although the FDA monitors these recalls, it generally allows manufacturers to take the lead in carrying them out. Mandatory recalls, where the FDA orders a company to act, are considered a last resort and are rarely used.
When a Dangerous Device Leads to Legal Action
Medical device recalls often lead to legal claims, particularly when patients suffer serious injuries before a defect is discovered or addressed.
As noted earlier, the CPAP recall has become one of the most prominent examples of this. In 2021, millions of devices used to treat sleep apnea were recalled after concerns emerged that sound abatement foam inside the machines could break down over time and release potentially toxic particles and gases. The recall was issued for devices that had been used by patients for years, raising concerns about long-term exposure and delayed warnings.
The scope of the CPAP recall and the fact that the dangers may have existed long before being publicly disclosed have become central issues in ongoing litigation. Plaintiffs allege that the manufacturer failed to test the devices adequately, warn consumers of potential risks, or act quickly enough once they identified the problems.
The CPAP lawsuits highlight a key issue in the recall system. Even when a recall is eventually issued, it may come only after widespread use and potential harm. In some cases, patients may not receive notice immediately or may continue using the device while awaiting repairs or replacements.
The CPAP cases resulted in a $1.1 billion settlement and raised questions about product safety, corporate responsibility, and the effectiveness of the recall process in protecting the public.
As the GAO report suggests, when regulatory action is limited or delayed, civil litigation may play a more prominent role in holding companies accountable and bring increased scrutiny to defective devices and the system responsible for identifying and removing them from the market.
Why the Recall Process Matters for Patient Safety
Medical device recalls are a critical safeguard in the healthcare system. When they work effectively, they can quickly remove dangerous products from the market and prevent further harm.
However, the GAO’s findings suggest that the current system may rely too heavily on manufacturers to police themselves. While many companies act responsibly, delays or inconsistencies in voluntary recalls can have real consequences for patients.
Understanding how recalls work and their limitations can help patients, healthcare providers, and policymakers better assess risk and advocate for stronger protections.
