FDA recall levels include which type characterized by not likely to result in adverse health consequences?

FDA recall levels include which type characterized by not likely to result in adverse health consequences?

• A. Recall I
• B. Recall III
• C. Market withdrawal
• D. Recall II

Answer: (D)

FDA recall levels reflect how likely and how severe the health impact could be. The level for an issue that is not expected to cause adverse health consequences is Class III recall. This indicates a low-risk defect—unlikely to harm patients even if used. Higher levels denote greater risk: Class II involves potential temporary or reversible health effects, and Class I involves a reasonable probability of serious health consequences or death. Market withdrawal is a separate action used when a product is removed for reasons not tied to a safety risk, so it isn’t the level describing not likely to cause harm.

FDA recall levels reflect how likely and how severe the health impact could be. The level for an issue that is not expected to cause adverse health consequences is Class III recall. This indicates a low-risk defect—unlikely to harm patients even if used. Higher levels denote greater risk: Class II involves potential temporary or reversible health effects, and Class I involves a reasonable probability of serious health consequences or death. Market withdrawal is a separate action used when a product is removed for reasons not tied to a safety risk, so it isn’t the level describing not likely to cause harm.