What is involved in a medical device recall? | Bart Durham Injury Law

What is involved in a medical device recall?

Medical device recalls are often discussed in the Nashville media, but it is not always clear from these reports what a recall actually involves. In fact, there are many aspects of the United States Food and Drug Administration’s recall process that the public may find surprising.

In some cases, it may seem as though federal agencies require recalls. While the FDA does have the authority to mandate a recall for a defective medical device, this is rarely necessary. Most companies will voluntarily initiate recall procedures when a product is found to be dangerous or improperly manufactured.

Not all recalls require that consumers stop use of a medical device entirely. The FDA explains that recalls are categorized as either corrections or removals.

In a correction, a product can continue to be used if it is fixed or adjusted. Additionally, in some cases physicians may be instructed to monitor patients who have used or been treated with a defective device. Patients in these situations must be informed about their medical options, along with any accompanying pros and cons. For example, people with defective hip implants may choose to have the devices removed. These patients’ doctors should provide information on the potential side effects of an additional surgery, as well as the possible harms of leaving the implant in.

More extreme situations may require the destruction or removal of a device. This means that these devices must be removed from the places in which they are used or sold. When a defective medical product has already been used, patients may need to consult with their physicians on how to proceed. 

No Comments

Leave a comment
Comment Information
Bart Durham Injury Law

You Deserve To Be Paid For What You've Gone Through

Our attorneys have more than 75 years of experience helping people like you.

Results For Our Clients

  • $3 Million Settlement - Passenger Hit By A Drunk Driver
  • $1 Million Judgment - Passenger Hit By A Drunk Driver
  • $1,450,000 Settlement - Passenger Hit By A Truck
More Client Results


  • "All of the staff members at Bart Durham Injury Law are very friendly and great to work with. They have open lines of communication with their clients, and respond in a timely manner. I trust them with my legal matters, and would advise anyone else in need of a lawyer to contact them first." - Julia Batson
  • "Bart Durham has a great team of people who are quick to respond and quick to help. The first time I met with them, they were kind and welcoming, and really listened to what I had to say. After my accident, I wasn't sure what to do, or how to get started. They took me through the process step by step, and got me the help I needed to continue on with my life. This is a friendly team with a dedication to helping people, and I'm so thankful for them!!" - Kara Davidson
More Testimonials