Devices
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A medical device is any device intended to be used for medical purposes. They range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology.
When a drug or device is either defective or potentially harmful, recalling that product is considered the most effective way to protect the public. The FDA defines a recall as " method of removing or correcting products that are in violation of laws administered by the U.S. Food and Drug Administration".
As per FDA, about 4,500 drugs and devices are pulled from U.S. shelves each year. As a consumer, it is important to be aware of devices or drugs that may affect your health.
Patients have no legal requirement to report adverse events, but healthcare providers and medical manufacturers are subject to mandatory reporting requirements.
Medical product reports are submitted through the MedWatch Voluntary Reporting Form.
FDA MedWatch Reporting Home
The FDA classifies each recall based on the severity of injury that the product may cause.
Class 1 Recall: This is the most serious type of recall. There is a reasonable probability that the product will cause serious adverse events or death. Products such as pacemakers, heart devices and lifesaving drugs fall into this category.
Class 2 Recall: The majority of recalls fall in this category. Products under a Class II recall can cause temporary or reversible adverse events. Many medical implants, such as hips or knees, fall in this category. Injuries from Class II devices can still be serious, though are not typically life-threatening.
Class 3 Recall: These products are not as likely to cause injuries..