It’s terrifying to learn that a medical device you’ve been relying on to assist you with a health issue may actually be causing you harm. With so many stories in the news, it’s possible that you may be feeling somewhat overwhelmed with information about hidden dangers in the marketplace.
The right knowledge can help you negotiate fear.
To help you better understand the U.S. Food and Drug Administration’s recall system, we’re going to break down some of the terms you may commonly see in conjunction with safety alerts on healthcare products. Knowing more may help you protect yourself or a loved one from harm, and it may help you better establish your eligibility for a faulty medical device lawsuit.
A recall occurs when a product in the marketplace presents a hazard to consumers or is not up to the manufacturer’s quality standards. The original manufacturer may initiate a recall independently, but if there is any degree of safety risk it is likely that the FDA will become involved.
Types of Recalls and Safety Alerts
- Class I recall – This signifies the highest degree of safety risk to affected consumers. Using this product, or possibly even handling it, could cause serious injury or death.
- Class II recall – Here, use of or exposure to the recalled product could cause minor injuries, or there is a very slight chance of injuries that are more extreme.
- Class III recall – The hazard presented by the recalled product is minimal.
- Market withdrawal – This happens when there is a problem with a product that isn’t subject to FDA penalties toward the manufacturer. An example of this would be when a third party tampers with a batch of products that weren’t under the protection of the maker or distributor. Here, the problem is handled by removing the product from consumer access.
- Medical device safety alert – This may be coupled with a classed recall. It happens when a medical device is discovered to potentially cause substantial harm.
However, please remember that in any recall initiated for safety reasons, there is always a chance of a victim sustaining a serious injury.
Have you been injured by a recalled medical device? Are you unsure how to take the next step in obtaining compensation for your suffering? Reach out to a Salt Lake City personal injury attorney at the James Esparza Law Firm. To set up a free consultation, call 800-745-4050 today.