Edwards, Frickle & Culver, Montana Trial Attorneys Edwards, Frickle & Culver, Montana Trial Attorneys
Toll Free: 888-706-7461
Montana: 406-545-5895

What are the different types of product recalls by the FDA?

Whether it is a common household good, food, an automobile, prescription medicine or other consumer products, individuals in Montana and elsewhere purchase these items under the impression that they are safe to use. Although manufacturers do not purposefully put a dangerous or defective product in the retail market, this could occur when errors occur in the design, manufacturing or retail process. In these cases, a recall is either issued by the manufacturer or the FDA.

What are the different types of product recalls by the FDA? A recall is considered an action taken to remove a product from the market, and depending on the risks the product could pose to the consumers, a recall could be one of three levels.

A Class I recall occurs when there is reasonable probability that the use of the product or the exposure to the product will cause serious adverse health consequences or death. This is considered the most serious type of recall and is for products that could serious harm or kill a consumer.

For a Class II recall to occur, it must be determined that the use or exposure to the product may cause temporary or medically reversible adverse health consequences. This type of recall also occurs when the probability of serious adverse health consequences is remote.

A Class III recall occurs when the use of or exposure to a product is not likely to cause adverse health consequences. This type of recall is likely to occur when a product is not working properly or is defective. However, the defects of the product do not make them dangerous.

In addition to these three levels of recalls, a market withdrawal could occur. This is when a product is found to have minor violation that would not be subject to FDA legal action. As a result, the manufacturer removes the product from the market or corrects the violations.

While a timely recall could prevent serious or fatal injuries from occurring, if a recall is not properly issued, consumers could be harmed. An injured consumer might have recourses in this situation. A products liability action could help the injured party recover compensation for losses and damages caused by a dangerous or defective product.

Source: FDA.gov, "Safety," accessed on March 7, 2016

No Comments

Leave a comment
Comment Information
  • The Best Lawyers In America
  • American Association for Justice
  • Super Lawyers
  • Salus Populi Suprema Lex Esto