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