AI Medical Device Recall Lawsuit | Patient Injury & Legal Options in 2025

Artificial intelligence has become the new gold rush in healthcare, and publicly traded med-tech companies are racing to release AI-enabled medical tools before competitors beat them to the punch. As of August 2025, the FDA has authorized more than 1,200 AI-driven devices—nearly twice the number cleared just two years earlier. But new research from JAMA Health Forum shows that this rapid acceleration comes with a dangerous tradeoff: the overwhelming majority of recalled AI devices are produced by public companies, where investor pressure often eclipses patient safety.

This trend has real consequences. The Lyon Firm is hearing from increasing numbers of patients injured by flawed diagnostic tools, malfunctioning monitors, and algorithmic systems that were never properly tested on real patients. If an AI medical product caused you harm, you may be entitled to significant compensation under product liability laws. Below, we break down the risks, the recall patterns, and how victims can take legal action.

Why AI Devices Are Reaching Patients Without Adequate Testing

AI promises faster evaluations, improved predictive analytics, and streamlined treatment decisions—but many devices are reaching the market with minimal safety evidence. The Johns Hopkins-led study, conducted with researchers from Georgetown and Yale, examined nearly 1,000 AI-enabled products approved through the FDA’s 510(k) process. This pathway allows clearance based on similarity to older technologies, frequently eliminating the need for human clinical trials. The findings raise major red flags:

• Public companies triggered more than 90% of all AI device recalls between late 2024 and 2025.

• Smaller publicly traded manufacturers performed the worst, with the vast majority of their recalled devices lacking any clinical validation.

• Even established corporations released untested devices, with a large share of their recalled products never evaluated on real patients.

One of the study’s authors, Johns Hopkins professor Tinglong Dai, stressed that nearly half of the recalled AI devices failed within their first year on the market, a sign that companies launched products long before they were ready for real-world use.

Most recalls stemmed from diagnostic failures—software delivering incorrect results, inconsistent readings, or misleading indicators that could cause delays in treatment, unnecessary surgeries, or missed life-threatening conditions. Other issues included dangerous functionality errors and physical hazards such as overheating components.

Public companies, driven by quarterly earnings expectations, often face strong financial incentives to prioritize speed over safety. As the researchers noted, when AI systems lack human testing, patients become the test subjects.

At The Lyon Firm, we are currently investigating cases in Ohio, California, and other states where AI-assisted imaging or monitoring equipment produced dangerous errors, contributing to preventable amputations, delayed cancer diagnoses, and other severe injuries.

2025 Recall Spike Highlights the Urgent Need for Oversight

The FDA’s recall data for 2024–2025 reflects a troubling pattern: more than 60 AI-enabled devices have been pulled in just over a year, ranging from infusion systems that delivered inaccurate medication doses to imaging software that mislabeled healthy organs as diseased. Publicly traded corporations were responsible for nearly all units recalled.

In one example highlighted by researchers, an AI-based cardiac monitoring tool—approved without clinical trials—generated widespread false alarms, leading to emergency visits and significant emotional distress among users.

Regulators are attempting to respond. Draft FDA guidance released in January emphasizes continuous monitoring, post-market data evaluation, and improved transparency for adaptive AI systems. Professional organizations such as the American Medical Association have reiterated that AI should function as “augmented intelligence,” always requiring human oversight to prevent catastrophic mistakes.

Still, regulatory efforts lag behind technological growth. Meanwhile, patients bear the consequences—both physically and financially.

From a legal standpoint, individuals harmed by defective AI products have strong claims under state product liability laws. Manufacturers can be held strictly liable for faulty designs, inadequate warnings, or hidden dangers. In states such as Ohio, injured patients generally have two years from discovering the injury to file a lawsuit, making swift legal action essential.

Why Injured Patients Choose The Lyon Firm for AI Medical Device Claims

AI-related product failures require a law firm that understands both the legal and technological complexities. The Lyon Firm brings decades of product liability experience and has secured over $100 million for injured clients nationwide.

What sets us apart:

• Advanced Technical Investigations: We collaborate with AI engineers, cybersecurity analysts, data scientists, and medical device specialists to uncover algorithm failures and hidden design flaws that other firms overlook.
• National Capabilities with Personalized Attention: Licensed in multiple states—including Ohio and California—we manage cases across the country without the red tape or impersonal approach of large corporate firms.
• No-Win, No-Fee Representation: We cover all litigation costs upfront. You owe nothing unless we secure compensation for you.
• A Track Record Against Medical Giants: Our team has successfully litigated against publicly traded healthcare and device manufacturers, forcing recalls, accountability, and safer industry standards.

If an AI-powered medical device misdiagnosed you, caused injury, or failed when you needed it most, you deserve answers—and compensation. Contact The Lyon Firm for a free, confidential case evaluation at (800) 513-2403. One conversation could be the first step toward justice.