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