Watchdog Report Exposes How the FDA’s Limited Oversight and Recall Failures Put Patients in Harm’s Way from Defective Medical Devices

FDA Oversight Under Fire After Recall Failures

Millions of Americans rely on medical devices to manage chronic conditions, maintain independence, or survive life-threatening illnesses. From breathing machines and pacemakers to insulin pumps and surgical implants, these devices play a vital role in patient care. When one of these devices is defective, timely action is critical. But a recent report from the U.S. Government Accountability Office (GAO) shows that the Food and Drug Administration (FDA) has failed to act in many cases where lives were at risk.

This investigation was prompted by the fallout from the 2021 Philips Respironics breathing machine recall, one of the most widespread and dangerous device recalls in recent memory. Despite receiving hundreds of complaints, the FDA did not use its legal authority to mandate a recall. Philips ultimately recalled the devices only after a significant delay, and thousands more people were injured while waiting for action.

This report has renewed concern that the FDA is understaffed, underpowered, and slow to protect patients, even in the face of clear warnings and harm. For those affected, it raises critical questions about legal responsibility, compensation, and how to hold negligent manufacturers accountable.

The GAO Report: What the Watchdog Found

The GAO’s investigation, released in December 2025, concluded that the FDA rarely exercises its power to force medical device recalls, even in cases where defective products are linked to serious injuries or deaths.

According to the report:

• The FDA regulates over 190,000 medical devices, an increase of 15,000 since 2016.
• Despite having legal authority to mandate recalls, the FDA has only used this power four times in history, with the last occurrence in 1992.
• Instead, the FDA relies on voluntary recalls, with about 900 initiated annually by manufacturers.
• Even after a recall begins, FDA staffing shortages often prevent the agency from verifying that recalls are implemented properly or that consumers are notified in time.

This lax enforcement leaves manufacturers with significant discretion — and patients at unnecessary risk. The watchdog agency found that the FDA’s internal systems for tracking recalls and ensuring public safety are severely outdated. For instance, recall notices are still faxed, and the FDA lacks the digital infrastructure needed for real-time alerts to doctors, hospitals, and patients.

The Philips Breathing Machine Recall: A Case Study in Delayed Action

The 2021 recall of Philips Respironics CPAP, BiPAP, and ventilator devices brought this issue to national attention. These devices contained a type of sound-dampening foam that could degrade and release harmful chemicals into patients’ lungs.

Despite years of complaints, the FDA took no action to force a recall. Investigations by ProPublica and the Pittsburgh Post-Gazette revealed that:

• Philips received thousands of internal complaints before acting.
• Patients continued to use dangerous devices for months or years without being warned.
• Those exposed reported respiratory illnesses, liver damage, kidney disease, and even cancer.

As of 2025, more than 500 deaths have been linked to these breathing machines, according to FDA data. Many victims were veterans, elderly patients, and infants — populations that rely heavily on respiratory support.

In a legal settlement announced last year, Philips agreed to pay over $1 billion to resolve lawsuits but did not admit liability. The delay in recall and lack of transparency cost lives and caused irreversible harm.

How the FDA’s System Is Failing Patients

The GAO report outlines multiple systemic failures that limit the FDA’s ability to safeguard public health. Among the most pressing concerns:

1. Outdated Notification Systems

The agency’s recall alerts are not integrated with modern digital platforms. Hospitals and doctors often don’t learn about dangerous devices until long after the risk is known. Many notices are still sent via fax.

2. Insufficient Staffing

Years of budget cuts, particularly during the Trump administration, reduced the FDA’s capacity to monitor device safety. The staff who remain often cannot review company-submitted recall status reports, which detail how many devices have been fixed or removed from use.

3. Failure to Enforce Mandatory Recalls

Although Congress gave the FDA the power to force a manufacturer to recall a device, the agency almost never uses it. Manufacturers frequently delay recalls or avoid them altogether, placing the burden of discovery on consumers and medical professionals.

4. Lack of Transparency

Patients harmed by defective medical devices are often left in the dark about what caused their illness. The agency’s failure to communicate effectively allows manufacturers to avoid public scrutiny for far too long.

Legal Responsibility When the System Fails

When federal oversight breaks down, individuals harmed by defective devices still have legal options. Manufacturers, not the FDA, are primarily responsible for ensuring that their products are safe and effective.

Patients and their families may be able to file product liability lawsuits, including:

• Design Defect Claims: If the device was inherently dangerous due to its design.
• Manufacturing Defect Claims: If a specific batch or unit was defective.
• Failure to Warn Claims: If the manufacturer knew or should have known about a risk and failed to warn users.

In some cases, there may also be grounds for wrongful death claims on behalf of loved ones who died due to complications caused by the device. Additionally, class action or multidistrict litigation (MDL) may apply when widespread harm is linked to a single product, as seen with Philips.

Who May Be Eligible to File a Lawsuit?

Anyone who experienced serious injury or illness linked to a recalled medical device may have a valid claim. Common qualifying injuries include:

• Cancer (lung, liver, kidney)
• Chronic respiratory problems
• Organ damage
• Neurological symptoms
• Death following device use

Eligibility may extend to patients who used defective products before a recall was issued, particularly in cases where manufacturers or the FDA delayed notifying the public.

Patients who were not informed of the risks and continued using defective devices for an extended period are especially likely to qualify for compensation.

Medical Device Injury Lawsuit Frequently Asked Questions

How do I know if my device was recalled?

You can search the FDA’s Medical Device Recall database online or contact your doctor or the manufacturer directly. Unfortunately, many patients were not properly notified due to communication failures at both the company and regulatory level.

What if I never received a recall notice?

Many users were not informed for months or years after their device was recalled. If you experienced health problems and were unaware your product was dangerous, you may still have a claim.

What kinds of injuries are linked to the recalled Philips machines?

Users of the recalled devices have reported respiratory illness, chronic coughing, sinus infections, organ damage, and various types of cancer. Over 500 deaths have been reported in connection to these machines.

Do I need to have a cancer diagnosis to file a lawsuit?

No. Respiratory issues, kidney or liver problems, and other related health conditions may also qualify. The key is whether your condition may be linked to foam degradation or exposure to toxic materials from the device.

What if the company already settled with others? Can I still sue?

Yes. Unless you were part of a class action settlement or signed a waiver, you can still pursue an individual claim for your damages. A lawyer can help determine if your case qualifies.

How much compensation can I recover?

Damages may include medical bills, lost wages, future care costs, pain and suffering, and in some cases, punitive damages. Each case is evaluated based on its specific facts.

Is there a deadline to file?

Yes. Statutes of limitations vary by state, but lawsuits must be filed within a certain time after injury or discovery. Don’t wait to explore your options.

Contact Parker Waichman LLP For A Free Case Review

If you or a loved one used a Philips Respironics CPAP, BiPAP, or ventilator and later developed respiratory illness, organ damage, or cancer, you may be entitled to significant compensation.

Parker Waichman LLP is a national personal injury law firm committed to holding negligent manufacturers accountable. We are reviewing claims related to FDA recall failures and defective medical devices, including the Philips breathing machine recall.

Call 1-800-YOUR-LAWYER (1-800-968-7529) today for your free consultation. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you. You don’t pay unless we win. Protect your health, your rights, and your future.