Medical device recalls are a way for manufacturers to remove a device that is not deemed safe by the Food and Drug Administration (FDA). Staying informed about medical device recalls is important for users, since the recall might indicate that a medical device can cause injury or death.
A medical device recall occurs when a device on the market violates the FDA law. The device may violate this law in several ways, however, recalls typically indicate that a product threatens patient health and safety. When a product is deemed defective, the manufacturer must notify the FDA and the users of the medical device. When a manufacturer does not voluntarily order a recall, the FDA can request or order the recall.
A defective medical device is classified in one of three tiers during a recall, depending on its determined risk to a patient’s health. The defective medical devices classified as Class 1 recalls indicate that the medical device could lead to a patient’s illness or death. Class 1 recalls are the most important tier due to the severity of the device on patient health.
When a medical device is classified as Class 2, this indicates that the device could lead to illness or death, however, the risk is much lower. It could also indicate that the medical device may cause a reversible illness. Lastly, the least threatening of the tiers is a Class 3 recall. This indicates that the medical device is defective, but not likely to lead to a patient’s death or illness.
In order to keep patients informed of medical device recalls, the FDA regularly updates its Medical Device Recall Database, including when the manufacturer initiates the recall and after the recall is terminated. The Medical Device Recall Database holds crucial information about the recall, and typically has press releases and other information posted on the database. It is important to note that not all recalls indicate that the device needs to be removed from the patient. Instead, the recall might indicate that a device needs to be checked, repaired, or adjusted. All patients should follow recall instructions to ensure their health and safety.
If you or a loved one was impacted by an unsafe medical device, contact a Philadelphia defective medical device lawyer at Brookman, Rosenberg, Brown & Sandler. We work closely with victims to hold manufacturers accountable for a defective medical device that leads to injury or death. Contact us online or call us at 215-569-4000 for a free consultation today. Located in Philadelphia, we proudly serve clients throughout Pennsylvania and New Jersey, including Delaware County, Chester County, and Philadelphia County.