Medical Malpractice Attorneys - Medical Device

Who recalls medical devices?

In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates the FDA law, it

Legally, the FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death. However, in practice, FDA has rarely needed to require a medical device recall.

 

What happens in a medical device recall?

When a company recalls a medical device, it

FDA oversees each recall to make sure that the actions the company takes are adequate to protect the public health. During a medical device recall, FDA

FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, Class II, and Class III. This classification process usually takes place after the company has issued its recall.

 

What is a recall?

A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.

What is a Class I recall?

A Class I recall 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.

In a Class I recall, the company:

FDA may also issue its own press release or public health notice.

FDA posts consumer information about all Class I recalls on its Medical Device Recalls website.

 

What is a Class II Recall?

A Class II recall usually represents 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.

In a Class II recall, the company notifies their customers (i.e. distributors or vendors) and sometimes asks them to notify the intended recipients of the device. 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).

 

What is a Class III Recall?

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.

In a Class III recall, the company notifies their customers (i.e. distributors or vendors). FDA would not issue a press release, and it would not expect the company to issue a press release.