FDA Medical Recalls

The US Food and Drug Administration (FDA) presides over recalls for medical devices. Often, manufacturers voluntarily conduct recalls of their products when they suspect or have had reports that their product poses a danger or risk to a patient’s health. While a particular product is in the process of being recalled, the company works to address the issue, so they can replace the old version with a corrected version as soon as possible. When the manufacturer doesn’t act soon enough on their own, the FDA may issue a mandatory recall.

Types of Recalls

Medical Device and drug recalls are classified in three categories based on the type of danger posed by the product:

• Class 1: The most serious – The product could reasonably cause a serious problem with health or even death.
• Class 2: Slight chance of serious health issue or death, or the product may cause a reversible or temporary health issue.
• Class 3: No health problems are likely to be caused by the product.

2018 Medical Recalls

As medicine advances, product developers are taking advantage of additional technology not previously utilized in earlier products. The more complex the apparatus or drug and the more advanced the technology, the possibility of something going wrong often increases. Additionally, it can take time to allow a product to be tested or be on the market for a while until the “bugs are worked out.”

Ideally, products should not go out into the marketplace before potential problems with devices or drugs have been found, though clearly this isn’t always the way it happens. Another issue causing recalls include many electronic devices requiring software updates. Updates often create additional issues. For this reason, the FDA continues to update recall lists regularly throughout the year. So far in 2018, the FDA has a list of 28 medical device recalls.

If you see your device on the medical recall list or suspect it should be, Tison Law Group can help you navigate the next steps. If you’ve sustained an injury or ill effect that you suspect was caused by a recalled product, or one that should be, don’t hesitate to contact the Tison Law Group for a free consultation.