Manufacturers and distributors of medical devices are responsible for protecting public health and safety. When products fail to meet the standard of the FDA, they pose a threat to the patient’s health, potentially leading to serious injuries and illnesses. If this occurs, you can take legal action. When medical device recalls happen, here’s what you need to know and what you need to do when you’re affected.
What are Medical Device Recalls and their Classifications?
A medical device recall is a process of removing or correcting a product that the FDA considers to be in violation of the law. Recalls provide a standardized procedure for manufacturers and distributors to help protect the public from defective products that may lead to injury.
There are three distinct categories that the FDA classifies recalled devices:
- Class I: A chance that a product will cause serious health problems or death.
- Class II: A product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.
- Class III: A product is not likely to cause any health problem or injury.
What is the Medical Device Recall Process?
Medical devices—such as pacemakers, hip implants, and monitoring machines—are all products that are under strict regulations and testing before being placed on the market. If a defect is discovered after release, manufacturers or distributors can voluntarily recall the device. When they initiate a recall, they are required to notify the FDA District Office.
The FDA will review the notification, evaluate the product’s health hazards, provide the recall classification, and provide recommendations to the firm’s recall strategy. Firms and the FDA will notify all affected parties; this is typically done by a letter that identifies the defective product, explains the nature of the defect, and what the next steps are.
Once the FDA classifies the recall, they will monitor the situation to ensure that the recall strategy has been effective. On rare occasions, the FDA may issue a mandatory recall if manufacturers fail to do so voluntarily, or if the product presents a serious threat to the health and safety of the public.
When to Contact an Attorney
A medical device recall can come too late for some patients, causing severe injuries and illnesses. In these types of situations, patients can file a lawsuit against the product’s manufacturer or distributor. If you or a family member have been harmed by a defective medical device, you may be entitled to compensation. Consider meeting with a personal injury lawyer who has experience in medical device recalls and help you get the justice you deserve.