FDA Recalls: What You Need to Know

FDA recalls are an ever-growing part of our everyday lives. FDA recalls are a serious matter that can have a big impact on consumers. If you have purchased a recalled product, it is important to know what to do.

In this post, we will discuss what FDA recalls are, why they happen, and what you can do if you have purchased a recalled product. We will also provide some tips on how to stay informed about recalls.

What Is an FDA Recall?

An FDA recall is a voluntary action taken by a company to remove a product from the market that is considered to be defective, unsafe, or otherwise violative of FDA regulations. The FDA can also initiate a recall if it finds that a product is unsafe or violative.

Recalls are classified into three categories:

• Class I: This is the most serious type of recall. Class I recalls involve products that could cause serious injury or death.
• Class II: This type of recall involves products that could cause temporary illness or injury.
• Class III: This type of recall involves products that are not likely to cause injury or illness, but that violate FDA regulations.

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FDA Recall Alert Examples

Certain Reworked DreamStation CPAP and BiPAP Machines by Philips Respironics

On February 10, 2023, the FDA issued a Class I recall for certain reworked DreamStations, which were also recalled back in June 2021. The latest recall was based on an issue wherein certain devices received inaccurate or duplicated serial numbers during their initial programming. This duplication poses a potential risk as it can result in the administration of therapy using incorrect prescription or default settings set by the factory. Moreover, there is a possibility that no therapy is delivered at all without any notification or alert to the user.

The consequences of receiving incorrect therapy or experiencing therapy failure can be severe, leading to various health conditions including respiratory failure, heart failure, significant injury, and even loss of life. 

Fruit Jelly Cup by Sunwave Brand (produced by Richin Trading Inc.)

A recall from a popular fruit jelly may affect families nationwide. Fruit Jelly Cup by Sunwave Brand was recalled on June 18, 2023, due to “a potential choking hazard based off the product size.” According to the FDA, the “ mall jelly cups have previously been implicated in choking deaths of children.”

In this case, there have been no reported incidents of choking, and the recall was voluntary (as a number of them are). However, the jelly cups were distributed nationwide. The full list of the affected products can be found here. 

What to Do If You Have Purchased a Recalled Product

If you have purchased a recalled product, it is important to take action. Here are some things you can do:

• Stop using the product immediately.
• Contact the company that manufactured the product. The company will usually have instructions on how to return the product or receive a refund.
• Report the recall to the FDA. You can do this by visiting the FDA website and clicking on the “Recalls” tab.

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Staying Informed About Recalls

The best way to stay informed about recalls is to sign up for FDA email alerts. You can also visit the FDA website regularly to check for new recalls.

If you have any questions about FDA recalls, you can contact the FDA’s Consumer Complaint Coordinators. You can find their contact information on the FDA website.

FDA recalls are a serious matter that can have a big impact on consumers. If you have purchased a recalled product, it is important to know what to do. By following the tips in this blog post, you can protect yourself and your family from harm.

Sources:

FDA Recalls: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

FDA Recall Types: https://www.findlaw.com/injury/product-liability/fda-recall-types.html

How to Conduct an FDA Recall: https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices