The U.S. Food and Drug Administration (FDA) is responsible for examining
and testing all new medical, cosmetic, and food-related products that
will be sold to the American people. In the case of medical devices, these
refer to any tool a doctor might use to treat a patient. If the FDA finds
a problem with a medical device they think might cause harm to a consumer,
they might recall the product. These recalls are separated into three
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.
If you were injured by a defective medical device, don’t hesitate
to talk to one of our skilled
Greenville product liability attorneys.
Christian & Davis LLC is dedicated to helping the victims of personal injury seek compensation
for their medical bills and lost wages. Let us see what we can do for you.
Contact us at (864) 408-8890 or fill out our online form to schedule a free case