Medical Device Recall Problems Raise Serious Questions About Patient Safety And Injury Lawsuits

Patients injured by recalled or defective medical devices may have claims against manufacturers and, in some circumstances, healthcare providers when safety failures cause preventable harm.

What Parker Waichman LLP Found

• Nearly 4,000 device recalls: FDA oversaw 3,934 medical-device recalls during fiscal years 2020 through 2024.
• Serious oversight delays: GAO found 74% of completed recalls exceeded FDA’s 90-business-day termination goal.
• Recall does not automatically prove liability: An injured patient generally must establish the applicable elements of a product-liability or other claim.
• Evidence may exist long before a recall: Adverse-event reports, complaints, testing records, internal communications, labeling changes, and regulatory submissions can become important evidence.
• Deadlines can be critical: Statutes of limitation and other filing requirements vary by state and by the type of defendant and claim involved.

Millions of Americans depend on medical devices to keep them alive, restore mobility, control chronic medical conditions, or improve their quality of life. Pacemakers, defibrillators, artificial joints, surgical implants, infusion pumps, ventilators, CPAP machines, insulin delivery systems, surgical tools, and other devices can become an essential part of a patient’s medical care. When one of these products contains a dangerous defect, however, the patient may have little ability to protect themselves from the consequences.

A December 2025 U.S. Government Accountability Office investigation identified significant weaknesses in the medical-device recall system. GAO reported that the FDA oversaw 3,934 medical-device recalls during fiscal years 2020 through 2024, and all of those recalls were initiated voluntarily by manufacturers. GAO also found staffing limitations affected FDA oversight and that 74% of recalls exceeded the agency’s 90-business-day goal for formally terminating a recall after completion.

These findings matter to injured patients because a medical-device lawsuit often concerns events that occurred well before the public learned that a device had been recalled. An investigation may therefore need to determine when a manufacturer first received warning signs, what adverse events had been reported, whether the company adequately investigated those reports, when doctors and patients were warned, and whether earlier action could have prevented the injury.

For patients, the fundamental question is not simply whether a product appeared on an FDA recall list. It is whether a medical device was defective or accompanied by inadequate warnings and whether that problem caused an injury that could support a claim for compensation.

How The FDA Medical Device Recall System Works

The word “recall” can create the impression that the government immediately orders a dangerous product off the market. The actual process is more complicated.

According to the FDA, almost all medical-device recalls are conducted voluntarily by manufacturers. The agency can order a mandatory recall in certain circumstances when a manufacturer or importer fails to voluntarily recall a device presenting a risk to health, but mandatory recalls are comparatively rare.

FDA recalls are divided into three classifications based upon health risk.

A Class I recall involves a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

A Class II recall applies when a device may cause temporary or medically reversible health consequences or when the probability of serious consequences is remote.

A Class III recall generally involves a product that is unlikely to cause adverse health consequences.

These classifications can become important in litigation, but they should not be mistaken for determinations of civil liability. A recall classification addresses regulatory risk. A lawsuit requires a separate legal analysis of the product, conduct of potential defendants, applicable state and federal law, causation, damages, and available defenses.

FDA Recall Delays May Leave Patients In A Difficult Position

One of the most troubling findings from GAO’s investigation concerns how long parts of the recall process can take.

GAO analyzed recalls initiated from fiscal years 2020 through 2024 and found that 74% exceeded FDA’s 90-business-day goal for terminating a recall after the manufacturer reported completing it. For Class I recalls, the average period between completion and FDA termination was 263 business days.

GAO also reported that FDA personnel said insufficient staffing prevented them from completing certain oversight activities, including some reviews of manufacturer status reports and in-person recall audit checks. Staff resources were concentrated on higher-risk recalls and earlier portions of the recall process.

The distinction between completing corrective action and formally terminating a recall is important. A recall remaining technically open does not necessarily mean patients continue to face an unresolved danger. Nevertheless, GAO found that lengthy timelines can create confusion for patients and healthcare professionals.

For someone injured by a device, the chronology becomes particularly important. Lawyers investigating a potential case may examine when the defect was discovered, when corrective action began, when FDA classified the recall, when physicians were notified, when the patient was notified, and what occurred between each of those events.

Adverse Event Reporting Can Reveal Earlier Warning Signs

A medical device does not necessarily fail simultaneously in thousands of patients. Safety problems may emerge gradually.

One patient experiences a malfunction. Another suffers an unexpected complication. A physician reports a problem. A hospital encounters a similar event. Eventually, enough information may accumulate to indicate that the problem is not isolated.

The FDA’s Manufacturer and User Facility Device Experience, or MAUDE, system contains reports involving suspected device-associated deaths, serious injuries, and malfunctions. Manufacturers, importers, and certain healthcare facilities have mandatory reporting obligations, while healthcare professionals, patients, and consumers can also submit voluntary reports.

The FDA cautions against treating these reports as proof that a device caused an injury. Reports can contain incomplete, inaccurate, unverified, or duplicative information, and the number of reports cannot by itself establish the incidence or prevalence of a particular problem.

That limitation does not make adverse-event information irrelevant to litigation.

When similar complaints accumulate, lawyers may investigate when the manufacturer became aware of them, whether engineers identified a common failure mechanism, whether additional testing was conducted, whether regulators were notified as required, and whether warnings were updated.

The timing can become particularly significant in a failure-to-warn case. If evidence establishes that a manufacturer knew or should have known of a material danger before an injured patient’s device was implanted or used, the adequacy and timing of warnings may become a central issue.

Failure To Notify Patients About A Recall Can Have Serious Consequences

For an implanted-device patient, receiving a recall notice can be far more complicated than returning an ordinary consumer product.

Removing a pacemaker, defibrillator, artificial joint, surgical implant, or another implanted product may itself involve significant medical risks. Physicians may determine that monitoring a patient is safer than immediate removal. Other recalls may require reprogramming, software updates, increased surveillance, replacement, or revision surgery.

That makes timely communication particularly important.

A patient who does not know about a safety problem cannot discuss those options with a physician. A device could continue malfunctioning while the patient remains unaware that other people have experienced similar problems.

When an injury occurs after a recall or safety communication, a legal investigation may examine exactly when relevant parties received notice and what they did afterward.

Medical records, recall letters, certified-mail records, electronic health records, telephone logs, manufacturer communications, device-clinic records, and physician notes can help reconstruct that timeline.

Tracking An Implanted Device Can Become A Major Problem

Determining exactly which product was implanted sounds straightforward. Sometimes it is not.

Medical devices may be identified through model numbers, serial numbers, lot numbers, unique device identifiers, implant stickers, operative reports, hospital records, device registration records, or patient identification cards.

Those details can become extremely important during a lawsuit because recalls frequently apply only to specific models, manufacturing periods, lots, serial-number ranges, software versions, or components.

A patient may know that they received a particular brand of artificial joint without knowing which model was implanted. A pacemaker patient may know the manufacturer but not the device’s serial number. Someone who underwent surgery years earlier may no longer possess an implant card.

For this reason, obtaining complete medical and implant records can be one of the first important steps in investigating a potential claim.

Preserving The Device Can Be Critical Evidence

When a medical device is removed during revision surgery, what happens next can materially affect litigation.

The explanted device may provide physical evidence of fracture, corrosion, component separation, degradation, wear, contamination, electrical failure, or another alleged defect. Patients considering litigation should tell their attorneys about an upcoming revision or removal procedure as early as possible. Counsel may need to coordinate appropriate preservation procedures with the healthcare facility, surgeon, pathology department, manufacturer, or other entities.

A removed product should not simply disappear before its evidentiary significance has been evaluated.

The same principle applies to external equipment. CPAP machines, infusion pumps, monitors, medical equipment, packaging, replacement components, instructions, recall letters, photographs, and electronic data may all contain useful evidence.

Software, Cybersecurity And Artificial Intelligence Create New Device Risks

Modern medical devices increasingly depend upon software.

That changes what a “defect” can look like.

A device may function mechanically while experiencing a software problem. Updates can alter performance. Connected devices may have cybersecurity vulnerabilities. Artificial intelligence may influence diagnostic or therapeutic functions. Networked systems may communicate with other equipment or transmit patient information.

FDA’s current recall information reflects this changing environment, with corrective actions increasingly capable of involving software and other nonphysical components rather than simply removing a physical product. FDA describes recalls as including both removals and corrections.

Litigation involving these technologies may consequently require preservation of software versions, update histories, configuration information, electronic logs, cybersecurity notices, and other digital evidence.

The 510(k) Process Can Become Relevant In Device Litigation

Medical devices can reach the market through different FDA pathways.

One is premarket approval, commonly called PMA, which applies to certain higher-risk devices and involves FDA review of safety and effectiveness information.

Another is the 510(k) process, through which a manufacturer seeks clearance by demonstrating that a device is substantially equivalent to a legally marketed predicate device.

The regulatory pathway can become important in medical-device litigation because federal preemption issues may limit certain state-law claims involving some federally regulated devices. The analysis can be highly device-specific and claim-specific.

For an injured patient, identifying the device therefore involves more than determining its commercial name. Attorneys may need to determine its regulatory history, applicable FDA submissions, subsequent modifications, warnings, recalls, and whether federal law affects available state-law causes of action.

Medical Device Recall Lawsuit FAQs

Can I File A Lawsuit If My Medical Device Was Recalled?

Possibly. A recall can provide important evidence that a product had a safety issue, but the recall itself generally does not establish every element necessary to recover compensation. Your claim must be evaluated under the law that applies to your case. Attorneys typically examine the exact device involved, the reason for the recall, when the product was manufactured and implanted or used, the nature of the alleged defect, the manufacturer’s warnings, and whether the problem caused your injury. Some people may possess a recalled device without having suffered a compensable injury, while other patients may have viable claims involving products that have not been formally recalled.

What If I Was Injured Before The Device Was Recalled?

An injury occurring before a recall can be highly significant. A subsequent recall may prompt investigation into what the manufacturer knew before the recall was announced. Attorneys may examine prior complaints, adverse-event reports, testing, engineering analyses, regulatory submissions, labeling changes, internal communications, and other evidence concerning the developing safety signal. The central issue may become whether the manufacturer knew or reasonably should have known about a danger and whether earlier corrective action or adequate warnings could have prevented the patient’s injury.

Can A Doctor Or Hospital Be Liable For My Recalled Device Injury?

Potentially, but liability is not automatic. A product-liability claim against a manufacturer differs from a medical-malpractice claim against a healthcare provider. A physician or hospital claim might involve allegations concerning negligent implantation, inappropriate treatment, inadequate informed consent, or an unreasonable failure to respond to relevant recall or safety information. Whether the conduct constitutes malpractice depends upon the applicable standard of care and state law. In some cases, the manufacturer may be the primary defendant even though treatment for the resulting injury occurred at a hospital.

What Should I Do If My Implant Has Been Recalled?

Contact the healthcare professional responsible for managing the device rather than making medical decisions based solely upon a recall announcement. Removing an implanted device can itself carry risks, and some recalls call for monitoring, software correction, reprogramming, or another intervention rather than immediate removal. You should also preserve your implant identification card, recall notices, medical records, correspondence, and information identifying the model, serial number, and lot if available. If revision surgery is planned and litigation is being considered, discuss preservation of the removed device with an attorney before surgery when possible.

Free Consultation For People Injured By Recalled Or Defective Medical Devices

Patients place extraordinary trust in medical devices and the companies responsible for designing, manufacturing, testing, monitoring, and warning about them. When a defective device fails, the consequences can include additional surgery, permanent disability, worsening medical conditions, substantial financial losses, or death.

Parker Waichman LLP represents injured people nationwide and investigates claims involving defective and recalled medical devices. A medical-device investigation can involve reviewing FDA records, adverse-event reports, recall information, regulatory history, medical records, product identification information, warnings, and evidence concerning when a manufacturer learned about a potential safety problem.

If you or someone in your family suffered an injury potentially associated with a recalled or defective medical device, Parker Waichman LLP offers free consultations. Call 1-800-YOUR-LAWYER (1-800-968-7529) to discuss your potential claim and learn about your legal options. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.