Table 2

Classes of FDA Recalls and Alerts

Class I recallReasonable probability that use or exposure to a device will result in serious adverse health consequences or deathExamples: defective implantable defibrillator; critical labeling error on a drug
Class II recallUse or exposure may cause temporary or medically reversible adverse health consequences; probability of serious adverse health consequences is remoteExamples: a drug that is understrength, but not used to treat a serious illness
Class III recallUse or exposure is unlikely to cause adverse health consequencesExamples: unlikely to cause health effects, but violate FDA labeling or manufacturing laws, such as a lack of English labeling on a retail food
Market withdrawalManufacturer-initiated: product has a minor violation that would not be subject to FDA actionExamples: 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 alertAdvisory that a medical device may present an unreasonable risk of substantial harm; in some cases, such alerts are also considered recallsExample: notification to the public of a serious defect in an implantable defibrillator