Medical device recalls are on the rise, and the causes behind them are shifting. In 2024, they hit a four-year high. By Q1 2025, Class I recalls—the most serious category—reached their highest level in almost 20 years. For the first time in more than five years, device failures surpassed manufacturing defects as the leading cause for recalls.  

That shift should prompt medical device manufacturers to ask a practical question: Which recall risks can be reduced earlier in the design process? While not every variable is within a manufacturer’s control, material selection often is. When bonding, sealing, substrate compatibility or sterilization performance are involved, the material specification can be one of the more important decisions a team makes. 

The numbers paint a costly and unwelcome picture for the industry. There were 1,059 recall events in 2024, reflecting an 8.6% increase over the previous year. Recalls cost the industry an estimated $5 billion in 2024 alone. A single contamination or seal failure event can erase $600 million in sales and recovery takes between two and five years.  

Why Material Spec Matters More Than Ever 

Device failures can stem from many root causes, including software, design and manufacturing process issues. But when the failure involves an adhesive, seal, tape, film, converted component or substrate interface, the material specification may be a controllable variable hiding in plain sight. The right material choice can support product performance, manufacturability and quality. The wrong one can pass initial qualification and still fail later under production or field conditions. 

Clearly, this is not an abstract compliance problem. For the first time ever, device failure was listed as the leading cause of medical device recalls in 2024, accounting for more than 11% of recalls. That data point also represented the highest rate in five years. Material-related issues are recurring themes in FDA recall records and are largely preventable when the right material is specified for the right application from the start. A recent Class I recall of ophthalmic surgical procedure packs illustrates how quickly a material performance failure becomes a regulatory event. Incomplete seals compromised the sterile barrier—a bonding integrity failure at the specification level. The FDA warned of infection risk to patients. No serious injuries had been reported as of late 2025, but the recall triggered a Class I action, indicating a reasonable probability of serious adverse health consequences. A different material decision earlier in the design cycle may have prevented it entirely. 

R.S. Hughes National Account Business Manager Zac Kniess has seen material-related recalls tied to inadequate adhesive curing, incomplete adhesive contact across the bond line, air bubbles, poor dispensing and changes in substrate behavior.  

Why Material Decisions Get Made Too Late 

“Material failures are often tied to production processes, such as curing light wavelength or intensity diminishing, adhesive not curing fully or adhesive not contacting the full bond line,” Kniess said. “Light-cured adhesives require the design to allow light to reach the adhesive; color or blocked light transmission can prevent the cure from working as intended.” 

Despite those risks, most material selection conversations occur after major design decisions are already locked in. Engineering teams may select an adhesive or bonding approach first, while procurement and operations teams later optimize for price, quotes, lead times and supply chain availability. That sequence can leave limited room to evaluate application performance under real-world conditions, including sterilization exposure, mechanical stress, long-term adhesion demands, curing variability, substrate changes or inconsistent material sourcing. 

Kniess said it’s not unusual for manufacturers to call him after most materials have already been specified. “Sometimes there is flexibility if the customer selects a difficult substrate, but often the core material decision has already been made,” he said. “Those teams may only re-enter the technical decision if pricing or lead times are out of line. By then, changing the specification can be expensive.” 

The risk with material decisions taking place late in the process is that the material may pass initial qualification but still fail later under production or field conditions.  

How to Have Better Material Conversations  

Better material conversations start before the specification is finalized. Engineering and procurement teams should first pressure-test whether the adhesive, seal, tape or converted component is compatible with the application environment, production process and quality requirements. Those conversations are most effective when the adhesive supplier, distributor and manufacturer’s technical team are involved early enough to validate the material choice against the actual application. Waiting until pricing or lead time becomes the issue can turn a technical decision into a costly late-stage change. 

“A good distributor plays a critical role not only in ensuring quality and compliance, but by essentially providing a recall prevention strategy,” Kniess said. “The distributor’s material knowledge, coupled with a medical device specialist’s understanding of the application and the regulatory issues and an adhesive supplier’s deep material and technical expertise, helps get material selection right earlier in the design cycle.”  

Kniess said this is where a distributor like R.S. Hughes can help manufacturers turn material selection into earlier, more strategic decisions.   

With device failure now a leading cause of medical device recalls, it’s time to recognize that material selection is a controllable variable that can benefit from earlier conversations. Manufacturers that treat material selection as a strategic decision rather than a procurement step are better positioned to reduce avoidable bonding, sealing and compatibility issues before they become recall events.  

R.S. Hughes ensures critical material conversations are initiated earlier—connecting engineering teams with adhesive and material expertise before the spec is locked and offering precision-converted components through Saunders by R.S. Hughes that are matched to the actual application environment.