What Does it Mean if a Medical Device is Subject to a Class I FDA Recall?

A Class I recall is the most serious type of recall for medical devices. Medical devices that are subject to Class I recalls may pose risks for serious adverse health consequences or death—and, in some cases, revision surgery or other emergency medical intervention may be necessary. If you have concerns, you should consult with a doctor promptly, and then you should talk to a defective medical device attorney about your legal rights.

Medical device recalls mean different things in different circumstances. As a result, if you or a loved one has a medical device that is subject to a recall, it will be important to make sure you have a clear understanding of the specific circumstances at hand.

This is especially true if the medical device is subject to a Class I recall.

Class I recalls are the most serious type of recall for medical devices. Medical devices that are subject to Class I recalls can pose serious health risks, and emergency medical intervention will be necessary in some cases. When it is too late to avoid complications (and their associated costs), talking to an experienced defective medical device attorney is the first step toward seeking financial compensation.

What Are the Different Classes of FDA Recalls (and What Do They Mean)?

The U.S. Food and Drug Administration (FDA) is responsible for overseeing the medical device industry in the United States. This includes administering medical device recalls. While the FDA occasionally requests and orders recalls, the vast majority of recalls are voluntary (though they often result from manufacturers facing legal action).

Whether requested, ordered or voluntary, all medical device recalls fall into one of three categories:

• Class I Recall – “[A] situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
• Class II Recall – “[A] situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
• Class III Recall – “[A] situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”

As you can see, Class I recalls are by far the most serious. Class I recalls are often accompanied by market withdrawals; and, in many cases, manufacturers will recommend that patients and healthcare providers stop using medical devices that are subject to Class I recalls. For patients with implanted medical devices, this may mean having their devices removed. In all cases, the risks for patients can be substantial; and, when these risks lead to complications, patients and their families can—and should—talk to an attorney about taking legal action.

What Should I Do If I Have a Medical Device that is Subject to a Class I Recall?

If you have a medical device that is subject to a Class I recall, your first priority should be to consult with your doctor. You should not strictly rely on the manufacturer’s recommendations—as, unfortunately, the manufacturer may not have your best interests in mind. Your doctor should be able to provide advice based on your specific medical circumstances, and you should rely on your doctor’s advice to make informed decisions about what to do next.

If you have experienced complications, if your doctor has recommended revision surgery, or if you are facing any other costs or consequences, you should talk to an attorney as well. You may have grounds to file a defective medical device lawsuit—and, if you do, you will need an experienced defective medical device attorney on your side.

FAQs: Filing a Defective Medical Device Lawsuit Related to a Class I Recall

Can I file a lawsuit if I have a medical device that is subject to a Class I recall?

Whether you are eligible to file a lawsuit depends on your individual circumstances. When you sit down with an experienced defective medical device attorney, your attorney will be able to assess your legal rights and determine if you have grounds to sue your device’s manufacturer.

How long do I have to file a lawsuit for a defective medical device?

The answer to this question also depends on the specific circumstances of your case. With that said, regardless of how long you have to file, we strongly recommend that you speak with an attorney as soon as possible.

What compensation can I seek if I have a defective medical device?

Patients who have experienced complications related to defective medical devices (including the need for revision surgery) can seek compensation for their financial and non-financial losses. In a typical case, this will include compensation for medical expenses and other out-of-pocket costs, lost earnings, pain and suffering, emotional distress, and loss of enjoyment of life—potentially among other financial and non-financial damages.

How an Experienced Defective Medical Device Attorney Can Help

Finding out that your (or a loved one’s) medical device has been recalled can be overwhelming. It can also be scary, particularly with a Class I recall. At Searcy Law, we are committed to helping patients and families seek just compensation when device manufacturers prioritize their profits over patients’ safety.  

If you have questions about your legal rights, one of our attorneys can explain everything you need to know. If you have grounds to take legal action and decide to file a lawsuit, we can fight for the full compensation you deserve. We handle all defective medical device cases on a contingency-fee basis, which means our clients pay nothing unless we win.

Schedule a Free Consultation with a Defective Medical Device Attorney at Searcy Law

To learn more about your legal rights from an experienced defective medical device attorney, contact us today. Our attorneys represent patients and families in cases involving all types of recalled medical devices. Call us at 800-780-8607 or tell us how we can help online to schedule a free consultation as soon as possible.