Recall Classifications — Class I · II · III
US-unique
FDA's three-class recall classification system is specific to the USA. The classification is assigned by FDA (not the manufacturer) based on the probability and consequences of adverse effects.
How FDA classifies recalls
FDA's recall classification reflects the health hazard of the recalled product:
| Class | Definition | Examples |
|---|---|---|
| Class I | There is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death | Faulty pacemaker lead that may cause arrhythmia; mislabelled insulin pump that could result in fatal dose error |
| Class II | Use of, or exposure to, a violative product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote | Device that may cause minor injury in rare circumstances; performance issue that is unlikely to cause serious harm |
| Class III | Use of, or exposure to, a violative product is not likely to cause any adverse health consequences | Labelling error with no health impact; minor cosmetic defect |
FDA's role in recall classification
The manufacturer initiates the recall and notifies FDA. FDA then classifies the recall based on its own health hazard evaluation. The manufacturer does not assign the classification — FDA does.
What happens after classification
- Class I recalls receive the highest FDA monitoring attention; FDA may issue a public notification (press release)
- All recalls are posted in FDA's Medical Device Recall Database