What FDA recall classes mean
FDA assigns every recall a class after evaluating the health hazard the product presents. Recall classification reflects the relative degree of health hazard. The definitions, in FDA's words (21 CFR 7.3):
| Class | Definition | Share of events on this register |
|---|---|---|
| Class I | a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. | 18% |
| Class II | a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. | 74% |
| Class III | a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. | 9% |
The class describes the product and the situation, not the firm. A firm with many Class I events is a firm whose products are of a kind where failures carry serious consequences (sterile injectables, implants, infant formula), as much as anything else.
Status
Ongoing: the firm is still notifying customers and retrieving product. Completed: the firm has done so and FDA is verifying. Terminated: FDA has determined that all reasonable efforts have been made to remove or correct the product and it is reasonable to assume that the product has been removed and proper disposition or correction has been made.
Voluntary or mandated
Almost every event on the register is "Voluntary: Firm initiated". FDA can mandate a recall of medical devices, infant formula, food, and some other products, and orders of that kind are marked "FDA Mandated".
Events and records
FDA publishes one record per product, each with its own recall number (for example D-1234-2025 for a drug, Z- for a device, F- for food). Records that belong to the same action share an event number, and this site groups them into 27,613 events from 87,508 records. Where records in one event carry different classes, the event is shown with the most severe.
Reading a reason for recall
The reason is the firm's or FDA's short statement of the problem: a labelling error, a contaminant, a failed sterility test, a software fault. It is quoted on the event page and is not rewritten here.