Enforcement Report Definitions

Recall and Field Correction: Action taken by a firm to either remove a product from the market or to conduct a field correction. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. 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.

Medical Device Notification or Safety Alert: Any communication issued by a manufacturer, distributor, or other responsible party or FDA to inform health professionals or other appropriate persons or firms of a risk of substantial harm from a medical device in commercial use. Notifications are issued at the request of FDA. Safety Alerts are voluntarily issued.

Injunction: A civil action taken against an individual or firm seeking to stop continued production or distribution of a violative product.

Seizure: An action taken to remove a product from commerce because it is in violation of the law. FDA initiates a seizure by filing a complaint with the U.S. District Court where the product is located. A U.S. marshal is then directed by the court to take possession of the goods until the matter is resolved.

Prosecution: A criminal action taken against a company or individual charging violation of the law.

Disposition: A final order entered by a court to conclude cases involving prosecutions or injunctions. Prosecutions may conclude with the entry of a plea, a verdict, and, if guilty, conviction and sentencing. Injunctions are resolved when a court imposes an order on a firm or declines to issue the order.

Indictment: A formal accusation by a grand jury that sets forth charges against a defendant and states when the alleged crime occurred. An indictment is not a finding of guilt. Guilt can only be determined by a judge or jury after a trial.

Information: A formal accusation by a U.S. attorney similar to an indictment except that the charges usually are not presented to a grand jury. An information alleges a misdemeanor rather than a felony except when consented to by the proposed defendant.