Recall Reason Form Instructions:

List the reasons for the recall. Make sure to be thorough, as this information helps classify it as a class I, II, or II recall. See the Definitions tab for class type definitions.


Definitions:

Notification of customers is required for Class 1 recalls and sometimes for Class 2 recalls when there is a threat to public health. Decisions on when notification is necessary can be determined through discussions with FDA. FDA has the authority to initiate a recall in class I situations, but typically a company voluntarily issues the recall notice.

Classifications of recalls:

  • Class I recall: reasonable probability of serious adverse heath consequences or death
  • Class II recall: may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
  • Class III recall: not likely to cause adverse health consequences