Given that medical devices are intended to improve health, we can understand
why it can be concerning to learn there may be a problem. Medical device
recalls are initiated when a device is found to violate U.S. Food and
Drug Administration (FDA) regulations. This may mean that the medical
device is defective, it poses a risk to health, or it is both defective
and a risk to health.
In most cases, the device manufacturer voluntarily recalls the device.
When a company recalls a medical device, it:
- Notifies the customers who received the product from them, and takes steps
to reach others who need to be notified (for example, by issuing press
releases or providing detailed instructions);
- Provides information to help users identify the product and take steps
to minimize health consequences; and
- Takes steps to prevent the problem from happening again.
The role of the FDA is to oversee the recall to verify that the actions
the company takes are adequate to protect the public health. In addition,
if a device maker fails to recall a device on its own, the FDA will often
step in. For example, if a company refuses to recall a device that is
associated with significant health problems or death, the FDA can compel
the company to recall the device.
The FDA classifies medical device recalls into three categories, which
reflect the degree of risk to public health: Class I, Class II, and Class
III. In addition to alerting patients and health care providers of the
seriousness of the recall, the FDA’s classification determines the
number of checks the company has to make and the number of audits FDA
will conduct to ensure the effectiveness of the recall action to protect
Below is a brief overview of the three categories, as detailed by the
- Class I recall: This is the most serious type of recall. In a Class I recall,
there is a reasonable chance that the product will cause serious health
problems or death. FDA may also issue its own press release or public
- Class II recall: These recalls generally pose a less-serious risk than
a Class I recall. In a Class II recall, there is either a possibility
that the device will cause temporary or reversible health problems, or
there is a remote chance that the device will cause serious health problems.
- Class III: The lowest level of recall represents the least amount of risk.
In a Class III recall, there is little chance that using or being exposed
to the device will cause health problems. However, because the product
violates FDA law, there is still a need to take an action to address the problem.
As this post highlights, there are some cases where
defective medical devices lead to serious complications and other health problems. When this happens, it is advisable to consult
with an experienced injury attorney to determine if you may be eligible
If you or someone you care about has suffered serious harm due to a dangerous
or defective medical device, don’t hesitate to contact
a San Diego product liability lawyer at the Law Offices of Robert Vaage
for a free consultation.