By Healthcare Brew Staff
less than 3 min read
Definition:
Medical devices are apparatuses, instruments, machines, etc. that help diagnose disease, administer a cure or treatment, or “affect the structure or any function of the body,” per the FDA. According to the WHO, there are more than 2 million medical devices on the market globally, ranging from artificial hips to tools that diagnose illnesses or diseases to systems for taking vital signs at home.
What are medical device recalls?
Each month, the FDA shares a list of medical devices it has recalled. They can be classified between Class III—the least severe, where a product violates FDA law but won’t likely become a health hazard—to Class I—the most extreme classification, where it could pose a risk of serious injury or death. Early alerts are also issued each month for devices that could eventually become Class I recalls.
For instance, Becton, Dickinson and Company’s Rotarex Atherectomy System was listed as a Class I recall on March 20. The FDA reported there were at least four deaths, 30 serious injuries, and 115 associated complications.
What is the future of medical devices?
Like many areas of life, the future of medical devices is in the hands of the rising generation. In August 2024, for instance, the NIH and education nonprofit VentureWell recognized medical devices that had been developed by undergraduate students. The top award-winning device was UroFlo, an automatic, self-adjusting bladder irrigation system.
And in April 2025, a bipartisan bill was introduced to create a payment system so devices that use AI or machine learning could be covered under Medicare. Without a system like this it can take years for Medicare to approve and pay out for treatments using these types of devices.
