FDA Class I, Class II and Class III Recalls

August 1, 2015

FDA Class I, Class II and Class III Recalls

We’ve all heard horror stories of a contaminated food that has caused serious illness or untimely death to a consumer. Luckily, there is a regulatory body in place, the Food and Drug Administration, that has a system in place to handle these types of situations. Here’s a rundown on how the FDA recall system works:

A product recall is an action to remove a product from the market. It can be initiated by the firm who manufactures the product, by FDA request or by FDA order. When a recall is issued, it falls into one of three categories:

  • Class I recall: there is a reasonable probability that the use of or exposure to the product will cause serious illness or death.
  • Class II recall: use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
  • Class III recall: use of or exposure to the product is not likely to cause adverse health consequences.

“Class I Recall” extremely urgent.
This type of recall is pretty rare, but when they happen, they make national news due to their urgency. Examples of Class I Recalls include labeling mistakes on prescription pills, food contaminated with bacterial pathogens, and defective artificial heart valves. In the event of Class I Recall, the FDA develops an individual plan specific to the manufacturer and the product involved to make sure that the product is completely removed from the market and the results are trackable.

“Class II Recall” intermediate threat.
A Class II recall is issued where there is no immediate danger of death or other serious injury linked to the product, but the risk of death or a serious injury is still present. This is a preventative measure when there are still health and safety risks involved. The FDA still implements the plan for removal of the product from the market.

“Class III Recall” no immediate threat.
This type of recall is issued when there is not an immediate danger to consumers, but a product has been released in violation of FDA regulations. For example, in 2010, a batch of children’s medicines were potentially contaminated with small pieces of plastic during manufacturing.

To keep up-to-date on food recalls, go to foodsafety.org. If you or a family member has contracted a foodborne illness, you are entitled compensation for medical expenses. The first step is to speak to an experienced personal injury attorney. Contact Schenk & Podolsky to schedule a consultation today.