FDA Recall Classes

FDA Market Withdrawal

appropriate when a product has a minor violation that would not be subject to FDA legal action

FDA Market Withdrawal

manufacturer must remove the product or correct the violation

Class II

used in a case where the use of the product may cause temporary health problems; probability of serious adverse health consequences remote

Class I

used in a case where there is a probability of death

Class III

used in a case where use of the product is NOT likely to cause adverse health consequences; has violated some FDA regulation

FDA Medical Device Safety Alert

used only for medical apparatus equipment when a medical device may present an unreasonable risk of substantial harm