It’s all too common to hear about a medical device being recalled in the news headlines.
Despite what you might expect, most recalls are not done by the FDA. They are usually voluntarily recalled by the medical device manufacturer.
Medical Device Recall Procedure
When the FDA learns of a problem with a medical device, they notify the medical device manufacturer of the problem.
After the FDA makes the manufacturer aware of the problem, typically the manufacturer will work with the FDA to make a plan to correct or remove the medical device from the market. In rare cases, a medical device manufacturer will refuse cooperate with the FDA to recall a defective medical device. When that happens, the FDA has the power to recall the medical device under 21 CFR 810.
After the medical device manufacturer starts the process to correct or remove the device from the market, the FDA lists the recall in its database. This database is updated as the recall progresses through the process – including when it classifies the seriousness of the recall and then again when the recall is complete.
How Is a Medical Device Recall Classified?
The plan to correct or remove the medical device from the market will depend on the class of recall that the device falls in. There are three different classes:
- Class I – There’s a good chance that the device will cause serious injury or death.
- Class II – There’s a chance the device will cause some temporary or reversible health problems, but will probably not result in serious injury or death.
- Class III – The medical device will not likely cause injury or death.
Once the recall has been classified, the FDA will notify the public in their weekly Enforcement Report. For Class I recalls, and some class II and III recalls, the FDA will post additional consumer information for the public. The FDA may also post company press releases and other notices regarding the recall.
Have you or a loved one been injured by a defective medical device? Contact the experienced medical device lawyers at Gilreath & Associates for your free consultation today.