AI Medical Device Recalls

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.

New research from JAMA Health Forum shows the overwhelming majority of recalled AI devices are produced by public companies, where investor pressure often eclipses patient safety.

The Lyon Firm is hearing from patients injured by flawed diagnostic tools that were never properly tested on real patients. If an AI medical product caused you harm, you may be entitled to compensation under product liability laws. Contact our lawyers to investigate your claim.

AI Devices Are Reaching Patients Without Adequate Testing

AI medical devices are reaching the market with minimal safety evidence. The Johns Hopkins-led study referenced above conducted with researchers from Georgetown and Yale, examined nearly 1,000 AI-enabled products approved through the FDA’s 510(k) process, and found that 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 like software delivering incorrect results or misleading indicators that could cause delays in treatment or missed life-threatening conditions. Other issues included dangerous functionality errors and physical hazards such as overheating components.

Public companies 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 where AI-assisted imaging or monitoring equipment produced dangerous errors, contributing to delayed cancer diagnoses and other severe injuries.

Recall Spike Highlights the Urgent Need for Oversight

The FDA’s recall data for 2024–2025 indicates 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.

In one example highlighted by researchers, an AI-based cardiac monitoring tool generated widespread false alarms, leading to emergency visits and significant emotional distress among users.

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.

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 or inadequate warnings.

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 millions for injured clients nationwide.

If an AI-powered medical device misdiagnosed you or failed when you needed it most, you may have a valid claim. Contact The Lyon Firm for a free, confidential case evaluation at (513) 381-2333.