The Food and Drug Administration (“FDA”) is an agency within the United States Department of Health and Human Services that is tasked with protecting the public by validating the safety and quality of a long list of items ranging from food to medical devices. Medical devices regulated by the FDA include medical machines, contrivance, implant, in vitro reagent, or other similar or related items.
When a problem with a medical device is brought to the attention of the FDA, it is possible that a recall will be ordered either by the agency or by the manufacturer or distributor of the product. A medical device recall is meant to address a problem with a medical device that violates FDA law. Examples of medical device recalls include when a medical device is defective or when it could be a risk to the health of the public.
If the FDA issues a recall for a medical device, it could mean one of a number of things including, but not limited to:
- The medical device needs to be checked
- The medical device needs to be adjusted
- The medical device needs to be fixed
- The medical device functioning as an implant needs to be removed
- The medical device needs to be corrected wherever it is sold
- The medical device needs to be removed from wherever it is sold
Recalls fall under three different types of classifications; Class I, Class II, and Class III. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
A correction or removal of a medical device is not considered to be a recall if the correction or removal was considered to be a market withdrawal whereby the device was not in violation of FDA law and the removal was predicated upon normal stock rotation practices or routine equipment adjustments.
During the first quarter of 2016, both the number of recalls and the number of recalled units fell approximately 30% from the two-year quarterly average. To date, 33 medical device recalls have been ordered by the FDA which is a major decline from 2014 when 60 recalls were issued.
If a recall is ordered, the manufacturer has the responsibility to anyone who received, purchased, or used the product to promptly notify by way of a press release or a detailed instruction communication. The provided information should help consumers to properly identify the product and minimize potential damage to their health.
If you have suffered adverse health effects as a result of a faulty medical device, it is possible that you may be entitled to compensation. Consulting with an experienced and skilled medical device attorney is the first step to receiving the justice that you deserve. Since 2004, the law firm of Jeremy Rosenthal has focused exclusively on personal injury law and makes it their priority to put your best interest first while supplying you with first class legal representation. Call (303) 825-2223 today to schedule a consultation.