FDA recalls are not typically due to a fundamentally bad product. More often than not, these recalls result in gaps in documentation, usability errors, design oversights, software issues, or manufacturing inconsistencies that slip through development. Although recalls are costly and damaging, it also provides a valuable learning experience for Medtech teams, especially those building new products today.
Recent recall trends reveal patterns. Comprehending these patterns can help device teams further strengthen design controls, sharpen risk management, and build overall safer and more reliable products from day one.
1. Usability and Human Factors Issues Are Leading Recall Drivers
Within the last couple of years, many high-profile recalls were brought about, not by hardware failure, but by interface confusion, unclear instructions, or workflow mismatches. The main takeaway should be: if users can misunderstand, they will. Human-centered design and robust human factors validation are no longer optional. Device teams need to test with diverse, real-world users early and document usability risks thoroughly before verification and validation to lock the design in place.
2. Software Failures Are Increasing as Devices Become More Connected
Software-controlled functions, wireless connectivity, and algorithm-driven behaviors now account for a growing portion of recalls. Issues include inaccurate readings, unstable updates, cybersecurity vulnerabilities, and unexpected device behavior after software patches.
Primary takeaway: Treat software like a clinical risk, not just a convenience feature
This means disciplined software lifecycle management, rigorous verification, and careful tracking of software revisions, especially those pushed post-market.
3. Manufacturing Variability Can Undo a Perfect Design
Often times recalls involve perfectly functional designs that were produced inconsistently. This could include minor variations in assembly, sterilization, packaging, or component sourcing that create outsized safety risks.
Primary takeaway: Design reliability depends on manufacturing reliability
Early collaboration between R&D, quality, and manufacturing helps identify where tolerances or processes could introduce failures, long before mass production begins.
4. Labeling and IFU Errors Continue to Cause Preventable Recalls
It is still shocking how many recalls stem from incomplete instructions, missing warnings, mislabeled components, or confusing diagrams. These issues often slip through because teams view labeling as “the last step,” rather than a regulated component of the device.
Primary takeaway: labeling is part of the device, not just an afterthought.
Treat IFUs, packaging, and labels similarly to design-controlled deliverables, and validate them with real users as you would validate the device itself.
5. Weak CAPA Systems Allow Small Problems to Become Big Problems
Some companies end up with recalls because early complaints were not tracked well or due to missed trends. A weak CAPA system allows risks to accumulate quietly until they hit a critical point.
Primary takeaway: An effective CAPA program protects the company and the patient.
Teams should ensure complaint handling, trending, and root cause analysis processes are truly functional, not just compliant on paper.
6. Recalls Reveal the Importance of Cross-Functional Collaboration
Across almost every major recall, the root cause traces back to a gap between teams:
- engineering didn’t fully communicate intent,
- QA missed a risk,
- manufacturing deviated from specification,
- or human factors wasn’t integrated early enough.
Primary takeaway: Quality and safety depend on communication.
The best device teams maintain continuous alignment between R&D, QA/RA, human factors, clinical, and manufacturing throughout development.
Final Thoughts: Learning Before It’s Too Late
FDA recalls aren’t just warnings; they’re blueprints for building better devices. The most successful MedTech teams study them closely and adopt proactive strategies that prevent those same issues in their own products.
By focusing on usability, software reliability, robust manufacturing controls, strong CAPA processes, and true cross-functional collaboration, teams can avoid the pitfalls that lead to recalls, and deliver safer devices that clinicians can trust.
If you have questions about the development process, feel free to reach out for help. We do hundreds of free consults every year to help guide innovators along their path of device development.