When a company has a recall of one of its medical devices, there are two general solutions it can take. The U.S. Food and Drug Administration will monitor the situation and ensure the company properly handles the medical device recall.
The FDA provides guidance and oversight to make sure the manufacturer is following protocols with the action it takes to remedy the situation. The options the company has are to issue a correction or removal.
Correction
A correction means the company will provide a solution to the issue that caused the recall. It could be providing repair services or a part that will remove the problem that makes the device unsafe for consumers.
Removal
A removal is taking the medical device off the market. This may happen because the company cannot find a solution to the issue or it may be too complex for the company to issue a fix to consumers.
Keep in mind
In general, when there is a recall, you should read what it is. This will give you valuable information. Sometimes, a recall may not even impact you. This happens a lot with food recalls where the recall is due to improper labeling for allergens. If you don’t have allergens, then that would not really impact your ability to use the product safely. So, just make sure you know what the recall is.
The recall information also will tell you the fix, which is essential to know what your next move will be. Sometimes, all you will need to do is contact your doctor and perhaps have a check-up. A recall does not always mean you can no longer use the device.
