Table 1.

Description of recall classes

Class I Defective products have a reasonable probability of causing serious adverse health consequences or death. 
Class II Defective products may cause temporary adverse health consequences, or the probability of serious adverse health consequences is low. 
Class III Defective products not likely to cause adverse health consequences, but violate FDA labeling or manufacturing laws. 
Class I Defective products have a reasonable probability of causing serious adverse health consequences or death. 
Class II Defective products may cause temporary adverse health consequences, or the probability of serious adverse health consequences is low. 
Class III Defective products not likely to cause adverse health consequences, but violate FDA labeling or manufacturing laws. 

Recall class definitions obtained from the FDA.24 

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