When companies learn that a medical device they have released to the public in Kentucky and throughout the country contains a defect or has the potential to inflict unexpected harm from its regular use, they often initiate a recall on the product. There are many reasons recalls occur. While a device is sometimes too dangerous to be kept on the market, there are also instances where devices simply require repair or just additional labeling.
As explained by the FDA, there are a number of actions that can be classified as recalls. Sometimes a company wants devices returned so they can be destroyed. However, many devices may only require modification or repair so that they can work properly. There are also instances where it is not clear that a device has problems, but the company wants to inspect the device to be certain the device can be used safely.
Some recalls involve medical devices, like artificial hips, that are implanted within patients. Not every recall requires the device to be removed. Once informed about the recall, doctors are tasked with telling patients about the problems found with their devices and explaining the risks of removing a device or leaving it in place. Patients with potentially defective devices may need to undergo monitoring to make sure their health is not compromised by the device.
A quick way to tell how serious the harm a device can pose is to pay attention to any classification the FDA places on the recall. A Class III recall means a device is unlikely to result in health problems or cause injury from use. Class II recalls exist when devices create nonpermanent health problems or if death or serious health problems are only slightly possible. Class I risks are the most dangerous, with a person risking serious health problems or death from using the device.
Recalls are very important to pay attention to. It may be necessary to consult a professional attorney if it is apparent a device has caused harm or injury or is a serious risk to do so. Keep in mind that medical devices can be defective in many ways, so do not read the information presented as actionable legal counsel or as medical advice.