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Understanding Medical Device Recall Classifications

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.

What is a Medical Device Recall?

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 patient safety.

Below is a brief overview of the three categories, as detailed by the FDA:

  • 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 health notice.
  • 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 for compensation.

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.