Types of Medical Device Recalls

A Class I recall is the most serious type and happens if there is a reasonable probability that exposure to a volatile product would cause serious health consequences or death. These tend to be extremely urgent cases and are relatively rare. In these cases, the FDA will also develop an individual plan specific to the manufacturer and the product involved to ensure compliance with the recall is complete. All items in this category should be recalled from the market and from people’s homes. One example of a Class I recall includes St. Jude’s Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators in late 2016.

A Class II recall happens when there is no immediate danger or death linked to the product; however, the product is still potentially dangerous. These are more preventative in nature but can still cause serious health and safety risks. One example of a Class II devices is the On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single-use, made by CryoLife in 2017.

These are the least immediate type of device recalls. There is no immediate or perceived danger of any health issues, but items have been released in violation of FDA regulations. An example of a Class III recall includes Optilite IgG4 Kit made by Optilite IgG4 Kit in 2017.