Recap: Medical Device Recalls Unpacked

On February 6, 2025, Gardner Law hosted an insightful Medical Device Recalls Unpacked webinar, bringing together legal and regulatory experts to discuss the complexities of medical device recalls, FDA expectations, and risk mitigation strategies.

The session, led by Amanda Johnston, Tim Philips, and David Graham, provided attendees practical guidance on handling recalls effectively while navigating regulatory and legal challenges.

We’re providing a recap of the webinar below. If you missed it, you can watch the recording here.

Key Takeaways

1. Preparation Is Key

• Understanding Recalls & FDA Regulations: A recall is a manufacturer-initiated action to correct or remove a product in violation of FDA regulations. Most recalls are voluntary, but the FDA has the authority to mandate them. Certain types of recalls must be reported to the FDA within 10 working days. Understanding the FDA’s definitions of recall, correction, and removal is key to determining whether a particular action qualifies as a recall.

• Health Hazard Evaluation & Classification: The FDA categorizes recalls as Class I (serious health risks), Class II (temporary or reversible health issues), or Class III (unlikely to cause harm). FDA conducts a health hazard evaluation (HHE) to classify recall actions. Companies should adopt a similar risk assessment framework that aligns with FDA’s process.

2. FDA Expectations and Recall Strategy Best Practices

• Early and Transparent FDA Communication: Companies are advised to engage with the FDA recall coordinator early in the process to discuss recall strategy, risk classification, and remediation efforts.

• Avoid Common Pitfalls: Failing to properly notify the FDA within 10 working days, downplaying risks, or executing “silent recalls” can lead to regulatory scrutiny, FDA warning letters, or even legal consequences.

• Effectiveness Checks & Termination: FDA requires robust tracking and verification to ensure affected products are removed or corrected. A recall is officially closed only when the FDA issues termination approval.

3. The Litigation Landscape: Managing Legal Risks Post-Recall

• Litigation Risks Are Real: Recalls can lead to product liability claims, contract disputes, False Claims Act investigations, and shareholder lawsuits. Transparency with FDA and industry stakeholders must be thoughtfully aligned with legal risk mitigation strategies.

• Best Defense Is Documentation: Companies should maintain clear records of recall decisions, risk analyses, and corrective actions to mitigate liability risks.

• Payer & Reimbursement Challenges: Government payers (e.g., Medicare, Medicaid) may seek recoupment for recalled devices, adding another layer of legal and financial exposure.

Amanda Johnston, Partner at Gardner Law, discussed the negative connotation associated with recalls. "Medical device companies obviously want to avoid recalls, but sometimes they are unavoidable and shouldn’t be viewed as a failure. It demonstrates the company’s commitment to patient safety and regulatory compliance. Recall decision-making should be baked into a medical device company’s quality management system, enabling proactive planning and fostering a culture of accountability.”

David Graham, Senior Counsel at Gardner Law, provided an overview of the litigation risks associated with recalls. “Being prepared for recalls in advance ensures that while you are going through a recall, you not only complete it correctly but have the information afterward that allows the company to tell a positive story in any subsequent litigation.”

As a former FDA compliance official and now a specialist with Gardner, Tim Philips has been on both sides of recalls, so he understands what’s necessary for a minimally disruptive solution: “Navigating a medical device recall is about more than regulatory compliance—it’s about protecting patients, preserving trust, and minimizing business disruption. Preparation, clear communication with the FDA, and thorough follow-through are essential to achieving the best possible outcome.” 

Contact Gardner Law

Gardner Law’s regulatory, compliance, and litigation attorneys provide tailored, strategic guidance to help businesses navigate FDA regulations, develop recall strategies, and mitigate legal risks. Contact us if you need assistance.