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                Industry Guidance For Recalls

Industry Guidance For Recalls Home
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          Recalls, Market Withdrawals, & Safety Alerts
          Industry Guidance For Recalls
          Recalls Background and DefinitionsIndustry Guidance For Recalls Recalls Background and Definitions
  
  	
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    PrintRecalls 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.

                                                                                  Content current as of:
      07/31/2014Industry Guidance For Recalls
 
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