What is involved in a medical device recall?

Medical device recalls are often discussed in the Nashville media, but it is not always clear from these reports what a recall actually involves. In fact, there are many aspects of the United States Food and Drug Administration’s recall process that the public may find surprising.

In some cases, it may seem as though federal agencies require recalls. While the FDA does have the authority to mandate a recall for a defective medical device, this is rarely necessary. Most companies will voluntarily initiate recall procedures when a product is found to be dangerous or improperly manufactured.

Not all recalls require that consumers stop use of a medical device entirely. The FDA explains that recalls are categorized as either corrections or removals.

In a correction, a product can continue to be used if it is fixed or adjusted. Additionally, in some cases physicians may be instructed to monitor patients who have used or been treated with a defective device. Patients in these situations must be informed about their medical options, along with any accompanying pros and cons. For example, people with defective hip implants may choose to have the devices removed. These patients’ doctors should provide information on the potential side effects of an additional surgery, as well as the possible harms of leaving the implant in.

More extreme situations may require the destruction or removal of a device. This means that these devices must be removed from the places in which they are used or sold. When a defective medical product has already been used, patients may need to consult with their physicians on how to proceed. 

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