FDA Faces Scrutiny Over Delayed Medical Device Recalls

GAO report reveals the agency's limited use of recall powers due to staffing and resource constraints

Apr. 12, 2026 at 10:37pm

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A ghostly, glowing X-ray image of a medical device's internal structure, conceptually illustrating the challenges the FDA faces in overseeing dangerous products.An X-ray image of a medical device reveals the complex inner workings that the FDA struggles to effectively monitor and recall when safety issues arise.Today in Pittsburgh

A new Government Accountability Office (GAO) report has uncovered concerning issues with the FDA's handling of dangerous medical device recalls. Despite its authority, the FDA rarely takes decisive action to remove defective devices from the market, leaving patients vulnerable to potential harm. The report attributes this to a severe lack of resources and staff at the agency, raising questions about its ability to protect public health, especially during emergencies.

Why it matters

The FDA's reluctance to force recalls has come under scrutiny after the 2021 recall of Philips Respironics breathing machines, which posed risks to millions of Americans. The investigation revealed the FDA had received numerous complaints about these devices for years but failed to issue a recall, highlighting the agency's limited use of its recall powers.

The details

The GAO report found the FDA has only mandated recalls four times, with the last instance in 1992. Instead, device manufacturers often initiate voluntary recalls, with approximately 900 cases in each of the past five years. The FDA's staffing issues, exacerbated by cuts under the Trump administration, hinder their ability to oversee recalls effectively, leading to delays in removing defective devices and communicating with consumers.

  • The GAO report was prompted by the 2021 recall of Philips Respironics breathing machines.
  • The last time the FDA mandated a recall was in 1992.

The players

Food and Drug Administration (FDA)

The federal agency responsible for protecting public health by regulating the safety and efficacy of medical devices, among other products.

Government Accountability Office (GAO)

The independent, nonpartisan agency that investigates how the federal government spends taxpayer dollars.

Philips Respironics

The manufacturer of the breathing machines that were recalled in 2021 due to toxic foam that could harm patients.

Senator Dick Durbin

A U.S. Senator who urged the GAO to scrutinize the FDA's practices regarding medical device recalls.

Senator Richard Blumenthal

A U.S. Senator who also urged the GAO to investigate the FDA's handling of medical device recalls.

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What they’re saying

“Patients deserve to be promptly informed of recalls to understand the risks and make informed decisions about their health.”

— Senator Dick Durbin, U.S. Senator

“The FDA's outdated recall notification system further complicates the situation, making it difficult to promptly inform patients of potential risks.”

— Dr. Rita Redberg

What’s next

Senators Durbin and Representative Jan Schakowsky have introduced legislation to enhance the FDA's recall process, aiming to modernize recall alerts and make it easier for companies, the FDA, hospitals, and doctors to share critical information with patients.

The takeaway

This investigation highlights the need for the FDA to be granted more resources and authority to effectively oversee and enforce medical device recalls, ensuring patient safety and timely communication of potential risks. The proposed legislation aims to address these systemic issues and improve the agency's ability to protect the public.