Notes on Laws & Requirements - Recalls

Question 1

FDA Class I Recall

Answer 1

FDA Class I Recall - WILL Cause Harm:
* Reasonable probability that use of/exposure to a violative product WILL cause extreme harm/death

Question 2

FDA Class II Recall

Answer 2

FDA Class II Recall - MAY Cause Harm:
* Reasonable probability that use of/exposure to a violative product MAY cause temporary or medically reversible consequences or if serious harm is remote.

Question 3

FDA Class III Recall

Answer 3

FDA Class III Recall - NOT LIKELY to Cause Harm:
* Reasonable probability that use of/exposure to a violative product is NOT LIKELY to cause harm.

Question 4

FDA Market Withdrawal

Answer 4

FDA Market Withdrawal:
* Product has minor violation that is subjec to FDA legal action, and is corrected by the manufacturer.

Question 5

FDA Medical Device Safety Alert

Answer 5

FDA Medical Device Safety Alert:
* Issued to medical devices that may present risk of harm.
* In some cases, these are also considered recalls.