Types of Recalls for Defective Medical Devices: Class I, II, III

If you have ever been notified about a medical device that’s been recalled, then you may have noticed a classification associated with that recall. It’s important to know what those classifications mean and how they might impact you and your health. Let’s take a look at some important factors to understand when it comes to recalled medical devices.

What are Medical Device Recalls?

Medical device recalls are very important to pay attention to. A defective product or one that violates the rules of the Food and Drug Administration (FDA) can pose the risk of serious injury or even death. The FDA explains a recall as the action a company takes once they are notified or are made aware of an issue relating to their product. Recalls are known for being issued because a product poses a threat of injury because of the way it was manufactured, distributed, or used. However, recalls can take place for a variety of other reasons including the following:

• The need to inspect a device for problems that may arise while using the product
• Repairing a component of the medical device
• Adjusting a setting on the medical device
• Relabeling a device
• Destroying a device

In some instances, a company may be able to determine that a device was made in a certain lot or model. In these instances, a company may recall every single device of a specific model or all units belonging to a certain lot of manufactured devices.

Who Determines a Medical Device Needs to Be Recalled?

A majority of the time, it is a company that determines that they have a product that either needs to be removed from the marketplace permanently or needs to be removed temporarily due to an issue that needs to be corrected and resolved. Once a company determines that they have a product that needs to be recalled, they will announce a recall on their product and then will notify the FDA.

If a company chooses not to recall a product, the FDA can step in and issue the recall for that product. Typically, however, companies usually will initiate the recall voluntarily.

Medical Device Recall Classifications

Once the FDA learns about a recalled product, they will investigate the company’s approach to either fixing that product through corrective action or removing that product entirely. Often the FDA will assign a classification to the medical device recall as part of their review. There are three different classifications the FDA will assign. They include Class I, Class II, and Class III.

Class III

This is the most serious of all three classifications. A Class III recall alerts the public that there is a reasonable chance that the recalled product will either cause serious health issues or death.

Class II

This type of classification alerts consumers that a product may cause either temporary or reversible health issues. This classification also indicates that a product carries a slight chance that it will cause a serious health issue or death.

Class I

A class I medical device recall alerts consumers about a defective product that carries very little risk of causing a serious health problem or injury.

After a recall has been issued and the FDA issues a classification for the recall, they will continue monitoring a company’s approach to recalling the product and remedying the situation that caused the recall in the first place. The company will be tasked with making sure that the product does not violate FDA law and does not pose a health hazard to consumers.

How Are Consumers Notified About a Recall

Once a product has been recalled, the FDA will alert consumers by posting information about the recall on the Medical Device Recall Database. Consumers will be able to find information about the product, why it was recalled, and what the action will be. Once the recall has been terminated, the FDA will update the Medical Device Recall Database.

The FDA may also post a company press release related to the recalled product. This is done through their weekly public Enforcement Report. Consumers will also be made aware of the different classifications of the recalled medical device.

Understand Your Rights

If you have been injured in Southern California by a medical device that has been recalled or have additional concerns and questions related to recalled medical devices, reach out to an experienced attorney today at the Morris Law Firm. We can help you gain the compensation you deserve if you have been seriously injured by a recalled medical device.