FDA Medical Device Recalls on the Rise

The data shows medical device recalls increased nearly 5% in Q1 2023 versus Q4 2022. The number of recalled units jumped over 34% to 83.3 million. However, one company was responsible for 75% of the recalls last quarter. Excluding them as an outlier, recalls are on par with previous years.

There are a number of factors that have contributed to the rise in recalls, including:

• Faulty manufacturing: The FDA has found that many of the recalled medical devices were manufactured with defects that could lead to serious injuries or death.
• Complexity of medical devices: Medical devices are becoming increasingly complex, which makes them more difficult to manufacture correctly.
• Shortages of critical components: The COVID-19 pandemic has led to shortages of critical components used in medical devices, which has made it difficult for manufacturers to meet quality standards.

The rise in recalls is a serious concern. Medical devices are intended to improve patient health, but faulty devices can have the opposite effect. Patients who use recalled medical devices are at risk of serious injury or death.

The FDA is taking steps to address the rise in recalls. The agency is increasing its inspections of medical device manufacturing facilities and is working with manufacturers to improve quality control. The FDA is pushing digital solutions to improve supply chains and prevent shortages. They also aim to boost cybersecurity, requiring eSTAR formatting for all 510(k) submissions after October. More coordination among manufacturers and better recall plans will reduce risks if defects occur.

While new technologies have benefits, risks remain. Companies should be cautious adopting unregulated innovations and watch for cyber threats when adding software. With vigilance, the industry can continue improving devices while avoiding major recalls.

Additional Resources

• Post-market Surveillance: https://postmarketmonitor.com/
• FDA Medical Device Recalls: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
• How to Report a Problem with a Medical Device: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

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