Medical device recalls are becoming more frequent and more serious. In 2024, the U.S. saw 1,059 medical device recalls, the highest number in four years. Even more concerning, Class These reached a 15-year high, according to Sedgwick’s 2025 US State of the Nation Recall Index report. This upward trend highlights the increasing complexity and risk involved in medical device development.
For OEMs and contract manufacturers, a recall is not just a regulatory event. It can disrupt supply chains, damage brand reputation, and most importantly, compromise patient safety.
Why Medical Devices Get Recalled
Understanding the root causes of medical device recalls is essential for prevention. Many of these issues arise during the product development lifecycle and could be mitigated with a more proactive approach.
Design Flaws and Manufacturing Errors
Devices must be designed to withstand real-world conditions such as heat, moisture, and mechanical stress. Even minor oversights can lead to serious failures like leaks, detachment, or component damage. According to the FDA, design-related issues and manufacturing defects are consistently among the leading causes of recalls.
Material Selection and Manufacturing Quality
Choosing the right materials is critical. Incompatible materials can compromise device integrity, interfere with sterilization, or react negatively with medications or bodily fluids. Even well-designed devices can fail if manufacturing processes are not tightly controlled. Surface imperfections, incorrect parts, and assembly errors continue to be major contributors to product recalls, as highlighted in the Sedgwick Recall Index.
Software and Cybersecurity Vulnerabilities
As devices become smarter and more connected, software reliability and cybersecurity are increasingly critical. Firmware bugs or security gaps can lead to performance issues—or worse, patient harm. In Q2 2025 alone, software issues accounted for 44 medical device recalls.
Best Practices to Minimize Risk
The FDA recommends a Total Product Life Cycle (TPLC) approach to device safety, integrating design, manufacturing, and post-market surveillance from the start. Formerra’s white paper, 5 Considerations for Minimizing Medical Device Recall Risk, builds on this framework with five actionable strategies:
1. Select the Right Materials: Ensure chemical compatibility, regulatory compliance, and long-term durability.
2. Design for Manufacturability: Optimize for scalability and consistent quality across production runs.
3. Collaborate with Trusted Suppliers: Build resilience into your supply chain through strong partnerships.
4. Integrate Risk Assessments Early: Use predictive testing and simulation to identify potential failure points.
5. Document Clearly and Thoroughly: Support compliance and usability with well-structured documentation.
Formerra’s white paper, 5 Considerations for Minimizing Medical Device Recall Risk, builds on the best practices outlined above to help reduce vulnerabilities and improve product reliability. Whether developing a new device or refining an existing one, these insights support smarter decisions throughout the entire product lifecycle.
