An In-Depth Look At How FDA Recalls Work & The Latest Urgent Medical Recall You Need To Know About

Law Articles

Every American needs to stay on top of product recalls issued by both the CPSC and the FDA. While the Consumer Product Safety Commission oversees the safety of many other everyday products, such as car seats, the FDA oversees the safety of medications, medical devices, animal feed, cosmetics, and food. As you can imagine, continuing to use a medication or eat a food that has been recalled by the FDA can be very hazardous to your health. 

If you have ever wondered just how the FDA determines that a medical, cosmetic, or food product needs to be recalled and how Class 1, Class 2, and Class 3 FDA recalls differ, then read on to find out. You'll also find out information about a recent urgent FDA recall that everyone needs to know about. 

How the FDA Decides That a Product Needs to Be Recalled

Only some of the products that the FDA oversees the safety of must be officially FDA-approved before they enter the US market. These products include mainly medications and medical devices. Cosmetics and foods do not need to be FDA-approved before they are sold in the United States, but the makers are expected to never place a product on the market that is hazardous to the health of the consumers who purchase it. 

However, the FDA has the power to recall FDA-regulated products, whether they approved them for the US market in the first place or not. 

Some recalls are initiated after the manufacturer of a product realizes that it poses a safety hazard to consumers and notifies the FDA. However, the process of initiating an FDA recall often begins when another government agency, such as the CDC, determines that a product is unsafe due to reports from consumers or medical professionals or after FDA personnel inspect a manufacturing facility and notice health hazards at the facility. 

How FDA Recall Classes Differ

By the time the FDA initiates an official product recall, it has decided just how dangerous the product is to the health of consumers. To help people and medical professionals understand just how hazardous a product is, the agency groups all recalls into three classes: Class 1, Class 2, and Class 3.

If a product is under Class 1 recall, then that means it poses an immediate danger of serious injury or death to consumers. When a product is under a Class 2 recall, it means that it is not expected to kill or greatly injure a consumer immediately, but still poses a health risk to consumers. Products under Class 3 recalls are less likely to harm consumers, but have still violated FDA safety standards and could be harmful to the health of consumers. 

A Recent FDA Class One Recall Everyone Needs to Know About

The FDA has recently issued a Class 1 recall on a specific brand of shoulder implant medical device. The recall was initiated by the manufacturer of the product after they found out that the implants are prone to fracture. 

As already mentioned, a Class 1 FDA recall is only issued when a medical device is expected to pose an immediate and serious health risk to a consumer. That means that if you have a shoulder implant, then you need to speak to your doctor as soon as possible to find out if your shoulder implant is the device under recall (not all shoulder implants are being recalled), then discuss whether removal of the device is right for you.  

If anyone you know has a shoulder implant or you know anyone who you suspect may have one, then pass this information along to them to help them protect their health. 

If you currently have one of these implants or had one in the past, then after speaking to your doctor, it is also important to join one of the shoulder recall lawsuits already in action. These lawsuits are class-action lawsuits that you can simply join without having to worry about paying any attorney's fees or dealing with the stress that comes along with filing a lawsuit on your own. 

Once you speak with one of the attorneys arranging a shoulder recall lawsuit, you can discuss the compensation you can likely look forward to receiving from the implant manufacturer when the case settles.

If the product recall causes you to have to have an additional surgery to replace the implant, then you should ask the attorney to ensure you are compensated for the medical bills, missed time from work, and pain and suffering you may endure during the surgery. However, even if your doctor decides that it is best for you to leave the shoulder implant in place for now, you may still be entitled to compensation from the implant manufacturer. 

It is important for everyone in the United States to understand how the FDA recall process works, what recall classes mean, and how to stay on top of new FDA recalls. If anyone you know has a shoulder implant, make sure they know that one implant produced by on manufacturer is under Class 1 FDA recall and that they need to discuss this information with both their doctor and an attorney. 


14 June 2017