Background and Definitions of Recalls

Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.

Class I recall

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.

Class II recall

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.

Class III recall

A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Market withdrawal

Occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

Medical device safety alert

Issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.

• Product Recalls
• Consumer Products
• Foods Medicines Cosmetics
• Motor Vehicles Car Seats
• Environmental Products
• Meat and Poultry Products
• Boats and Boating Safety
• Recalls and Class Action Verdicts

• Class Action Litigation
• Mass Torts
• Recalls and Class Actions

• Recalls and Class Action - U.S. Food and Drug Administration
Includes the most significant product actions of the last 60 days, based on the extent of distribution and the degree of health risk.