Table 2.

Classes of FDA Recalls and Alerts^∗

Class I recall	Reasonable probability that use or exposure to a device will result in serious adverse health consequences or death	Examples: defective implantable defibrillator; critical labeling error on a drug
Class II recall	Use or exposure may cause temporary or medically reversible adverse health consequences; probability of serious adverse health consequences is remote	Examples: a drug that is understrength, but not used to treat a serious illness
Class III recall	Use or exposure is unlikely to cause adverse health consequences	Examples: unlikely to cause health effects, but violate FDA labeling or manufacturing laws, such as a lack of English labeling on a retail food
Market withdrawal	Manufacturer-initiated: product has a minor violation that would not be subject to FDA action	Examples: routine updates and equipment adjustments and repairs. This differs from a voluntary “recall” in that a recall involves a violation that would be subject to FDA action
Medical device safety alert	Advisory that a medical device may present an unreasonable risk of substantial harm; in some cases, such alerts are also considered recalls	Example: notification to the public of a serious defect in an implantable defibrillator

^∗From the U.S. Food and Drug Administration (FDA), available at: http://www.fda.gov/Safety/Recalls/ucm165546.htm. Accessed June 17, 2016.