A report released on Friday from the U.S. Food and Drug Administration
(FDA) shows that the number of medical device recalls has increased by
97 percent. The Center for Devices and Radiological Health (CRDC) is the
group in charge of issuing medical device recalls and had a primary goal
of lowering the amount of time it took to alert the public when a problem occurred.
While the information shows that actual recalls increased from 876 in 2010
to 1190 in 2012, the group was successful in its objective to give the
public ample notice time, lowering the number of days a product was on
the market by 56 percent.
The FDA reports that the most common reasons a device gets recalled is
because design, software, non-conforming material, or component issues.
It also says, “If industry and CDRH can address these problems jointly,
we may be able to prevent as many as 400 recalls each year.”
As a conclusion, the FDA states that they believe the rise in recalls is
actually a result of increased awareness by all involved parties. They
estimate that these numbers will begin to reduce in upcoming years because
the manufacturers are gaining useful knowledge and tools to improve device
You can go
here to read the whole report. The FDA has also created a page that keeps up
to date on medical device recalls. You can sign up at that site to receive
email notifications when they issue new recalls or find contact information
if you have more questions. Click
here to view that page.