Practical guide 3 min read
Recall classes explained: Class I, II and III
What the FDA's recall classes, Canada's classes and types, and UK and EU alert levels mean, with how often each one comes up.
What a recall class tells you
Food, medicine and medical device recalls come with a class or type that says how serious the health risk is. It's the quickest way to judge a recall: a Class I recall means stop now, while a Class III recall is usually a labelling or quality problem that won't hurt you.
The class is shown in the Risk level line of a recall's "At a glance" box on Product Recalls.
United States: FDA Class I, II and III
The FDA classifies every food, drug and device recall in its weekly enforcement reports:
- Class I: there's a reasonable probability that using or eating the product will cause serious health problems or death. Undeclared allergens, Listeria and Salmonella are typical Class I food recalls.
- Class II: the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
- Class III: using the product is unlikely to cause any health problem, for example a minor labelling error.
Most recalls are Class II. Of the 1,821 recalls in the FDA's enforcement reports in the 12 months to September 2026 (counting each recall once, however many products it covers), 1,367 (75%) were Class II, 341 (19%) Class I and 111 (6%) Class III. Food recalls lean more serious than medicine and device recalls: 203 of 525 food recalls were Class I, against 138 of 1,296 for medicines and devices, because allergens and bacteria can cause immediate harm.
FDA press releases often appear before the recall is classified, so a new recall may show no class for a few weeks.
Canada: classes for food, types for health products
- Food (Canadian Food Inspection Agency): Class 1 is a high risk that eating the food will lead to serious health problems or death; Class 2 a moderate risk of temporary health problems; Class 3 a low or no risk, such as a labelling problem.
- Drugs and medical devices (Health Canada): the same three levels are called Type I, Type II and Type III.
Consumer product and vehicle recalls in Canada don't carry a class; the notice describes the hazard instead.
United Kingdom: the kind of alert
The Food Standards Agency doesn't grade recalls by number. The kind of alert tells you what it's for:
- Product recall information notice: a food is being recalled from shops and customers because it's unsafe.
- Allergy alert: a food contains an allergen that isn't on the label, or is labelled wrongly. It's only a risk to people with that allergy.
- Food alert for action: instructions to local authorities, usually about a wider problem.
The Office for Product Safety and Standards, which handles non-food products, gives a risk level instead, such as "serious risk".
European Union: serious risk
Safety Gate, the EU's alert system for non-food products, only publishes products that pose a serious risk. Each alert names the risk (electric shock, chemical, choking, fire) and the measure taken, such as a recall from customers, a withdrawal from shops, or an import rejected at the border.
Classes aren't the whole story
A lower class isn't permission to ignore a recall. Class II covers plenty of products you shouldn't keep using, and a Class III labelling error can matter a great deal to someone with an allergy. Read the The hazard and What to do sections of the recall, and if you're unsure, follow the recall's instructions anyway. See what to do if something you own is recalled.