Below is a list of medical device recalls. Both government
mandated and manufacturer voluntary recalls are included.
This list has been edited to ensure
the removal of food, drink, and other non-device related
recalls. For a comprehensive listing of all recalls regardless
of product category, we suggest you visit www.fda.gov for
more information.
Unsure of FDA Recall Notices and their meaning? Here are
the definitions used by the FDA’s Recall Classification
System.
Did you know?
Recalls are actions taken by a firm to remove a product
from the market. Recalls may be conducted on a firm's
own initiative, by FDA request, or by FDA order under
statutory authority.
| A Class I recall is a situation
in which there is a reasonable probability that the
use of or exposure to a violative product will cause
serious adverse health consequences or death. |
| A Class II recall is a situation
in which use of or exposure to a violative product
may cause temporary or medically reversible adverse
health consequences or where the probability of serious
adverse health consequences is remote. |
| A Class III recall is a situation
in which use of or exposure to a violative product
is not likely to cause adverse health consequences. |
| A Market Withdrawal occurs when
a product has a minor violation that would not be subject
to FDA legal action. The firm removes the product from
the market or corrects the violation. |
| A Medical Device Safety Alert is
issued in situations where a medical device may present
an unreasonable risk of substantial harm. In some case,
these situations also are considered recalls. |
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