Medical device recalls: Common questions | Bart Durham Injury Law

Medical device recalls: Common questions

A medical device recall is every bit as serious as it sounds. When a company finds that there is a problem with one of their devices, they are expected to take immediate action. This can mean one of two things:

  • Removal. This is when the device is removed from the market so that it doesn't reach any additional patients.
  • Correction. This is when corrective action is put into place to avoid the same issue in the future

Here are a few of the more common questions regarding medical device recalls:

  • Who is responsible for issuing a recall? In most cases, a company is responsible for issuing a recall after learning of a problem. They are responsible for not only initiating the recall, but also notifying the FDA.
  • What role does the FDA play? Once the FDA learns of a recall, it reviews the strategy the company will use to address the concern. The agency also looks for potential violations of its requirements, and in some cases assigns a recall class.
  • What does the FDA do to notify the public of the recall? In addition to posting the information in its medical device recall database, the agency may also issue a press release to inform the public.

Despite the fact that there is a system in place for dealing with medical device recalls, many people are still injured and killed every year as a direct result of a defect. If you find yourself in this position, you need to focus on your health and wellbeing while learning more about your legal rights.

Source: FDA, "What is a Medical Device Recall?," accessed Nov. 27, 2017

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