FDA Recall Classes
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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
