Medical Device Recalls

What Happens in a Medical Device Recall?

According to the FDA:

When a company recalls a medical device, it is required to contact directly the customers who received the product. It must also take steps to reach others who need to be notified.  Most commonly, this is accomplished by issuing press releases or providing detailed instructions.

The FDA oversees each recall to make sure that the actions the company takes are adequate to protect the public health.

Medical Device Recalls require special attention.
Medical Device Classifications are referred to as a Class I, Class II, or Class III.

Class I–High Risk
A Class I high risk recall is the most serious type of recall. A Class I recall is where a device may cause serious health problems or even death.

The company must notify their customers, distributors or vendors and direct them to notify the intended recipients of the device. This includes vendors, hospitals, nursing homes, outpatient treatment facilities, doctors, or individual patients. The notification usually contains the name of the device being recalled, identifying lot or serial numbers, the reason for the recall, and instructions about how to correct, avoid, or minimize the problem. It should also provide a telephone number for questions related to the recall.

Class II–Less-Serious Risk
A Class II recall usually represents a less-serious risk.  Generally, 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.

The company notifies their customers and sometimes asks them to notify the intended recipients of the device. The FDA generally does not issue a press release or expect the company to issue a press release for Class II recalls, unless there is a specific need to do so (for example, if the device could affect the health of a large number of people, if patients need more information, or if the recalling company could not reach every intended recipient).

Class III–Low Risk
A Class III recall represents a less-serious risk than a Class II recall. 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.