Recall glossary

Class I recall#

The most severe recall classification under FDA and USDA rules. Class I means there is a reasonable probability that using the product will cause serious adverse health consequences or death. Listeria monocytogenes contamination of ready-to-eat food, undeclared major allergens, and structural vehicle defects almost always qualify for Class I treatment.

Class II recall#

The middle FDA/USDA recall tier. Class II means the product may cause temporary or medically reversible adverse health consequences, where the probability of serious harm is remote. Most drug recalls (out-of-specification potency, contamination caught early) and many food recalls (low-level allergen mislabeling) land here.

Class III recall#

The lowest FDA/USDA recall tier. Class III means using the product is unlikely to cause adverse health consequences but the product still violates an agency rule — for example, a labeling error, a UPC mismatch, or a documentation defect. Many medical-device software corrections are filed as Class III.

Voluntary recall#

A recall initiated by the manufacturer, often in consultation with the relevant agency. The vast majority of US recalls are technically voluntary — the manufacturer recalls the product, the agency reviews and classifies, and an enforcement record is published. CPSC recalls are almost exclusively voluntary joint announcements.

Mandatory recall#

A recall ordered by an agency. The FDA has mandatory-recall authority for food (under FSMA), tobacco, and infant formula; the CPSC has it for consumer products; NHTSA has it for vehicles. Mandatory recalls are rare because most manufacturers cooperate voluntarily once an agency identifies a hazard.

Market withdrawal#

Removing a product from sale for a minor issue that doesn't meet the legal definition of a recall — usually a labeling correction or a minor compliance issue with no health risk. Market withdrawals aren't classified Class I/II/III and are typically not included in our database.

Field action#

An umbrella term for any action a manufacturer takes to address a problem with a product already in the marketplace — recalls, corrections, safety alerts, software updates, IFU revisions. Not every field action is a recall, but every recall is a field action.

Field Safety Corrective Action (FSCA)#

The standard term used in international medical-device regulation for what US FDA calls a device recall or correction. FSCAs include physical returns, software updates, labeling changes, and warnings. The FDA accepts FSCA notifications under its 21 CFR 806 reporting rules.

CAPA (Corrective and Preventive Action)#

A formal quality-system process required by FDA Part 820 for medical-device manufacturers (and recommended for food and drug manufacturers). A CAPA documents the root cause of a problem, the corrective action taken to fix existing affected product, and the preventive action taken to keep the problem from recurring. Recalls often trigger CAPA investigations.

510(k) clearance#

The most common FDA premarket pathway for medical devices. A 510(k) submission demonstrates that a new device is substantially equivalent to one already on the market. Many medical-device recalls reference the 510(k) number of the cleared device, listed in our raw_source_data as 'k_numbers' for FDA Device recalls.

Premarket Approval (PMA)#

The most rigorous FDA medical-device pathway, used for Class III devices like implantable pacemakers and heart valves. Recalls of PMA devices are taken more seriously than 510(k)-cleared devices because PMA devices are by definition life-sustaining or life-supporting.

NHTSA Campaign Number#

The canonical identifier for a NHTSA vehicle recall. Format: two-digit year, one-letter product code (V for vehicle, T for tires, C for child seats, E for equipment), then five digits — for example 25V123000. Every vehicle in our database can be looked up against open NHTSA campaign numbers via the VIN search.

VIN (Vehicle Identification Number)#

The 17-character identifier stamped on every road vehicle made for the US market since 1981. NHTSA's vPIC service decodes a VIN into make, model, year, body style, and engine. Our VIN lookup uses vPIC to translate your VIN and then cross-references NHTSA recall campaigns.

FMVSS (Federal Motor Vehicle Safety Standard)#

Federal regulations defining minimum safety performance for motor vehicles and motor-vehicle equipment. Vehicle recalls often cite the FMVSS number a defect violates — for example, FMVSS 208 (occupant crash protection, airbags) or FMVSS 138 (tire pressure monitoring).

Lot code#

A production-batch identifier stamped on packaged products. A recall notice almost always identifies affected product by lot code or by a date range visible on the package (best-by, sell-by, use-by, production date). Match the lot code on your package against the affected lots in the notice before assuming the recall covers it.

UPC (Universal Product Code)#

The 12-digit bar code on retail products in the US. FDA food recall notices include the UPC of the affected packaged product so distributors and retailers can pull stock cleanly. We surface UPCs as a searchable field — pasting one into search will find the matching recall directly.

NDC (National Drug Code)#

The FDA's unique 10- or 11-digit identifier for every drug product marketed in the US. NDCs are written on the label as three hyphen-separated segments (labeler, product, package size). FDA drug recall notices identify affected lots by NDC plus lot number.

Listeria monocytogenes#

A foodborne pathogen with unusual cold-tolerance — it can grow in refrigerated ready-to-eat foods. Listeria infection (listeriosis) is dangerous for pregnant women (miscarriage risk), newborns, the elderly, and immunocompromised people. Listeria contamination of refrigerated ready-to-eat food almost always triggers a Class I recall.

Salmonella#

A genus of foodborne bacteria responsible for one of the most common forms of US foodborne illness. Most healthy adults recover without treatment, but salmonellosis can be severe in young children, the elderly, and immunocompromised people. Salmonella detection in food triggers Class I recalls when paired with confirmed illnesses, Class II when caught preemptively.

E. coli O157:H7#

A particular serotype of E. coli that produces Shiga toxin and can cause severe illness — bloody diarrhea, hemolytic uremic syndrome, kidney failure. E. coli O157 is the strain commonly associated with ground-beef and leafy-green outbreaks. Any detection in a finished food product is a Class I recall.

Undeclared allergen#

When a product contains one of the FDA's nine major allergens (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, sesame) without disclosing it on the label. Undeclared allergens are one of the most common reasons for a food recall and are Class I if the allergen is one a typical allergic consumer can't taste or smell out of the product.

openFDA#

The FDA's public REST API at api.fda.gov. The Recall Desk ingests three openFDA endpoints — food/enforcement.json, drug/enforcement.json, device/enforcement.json — every six hours. The raw openFDA records are preserved verbatim in our recall detail pages.

SaferProducts.gov#

The CPSC's public-facing recall and consumer-report portal. CPSC's legacy REST API at saferproducts.gov publishes voluntary recall press releases as structured JSON — that's the feed our CPSC ingestor uses.

FSIS recall API#

USDA Food Safety and Inspection Service's public recall endpoint at fsis.usda.gov/fsis/api/recall/v/1. Returns the full FSIS recall archive (~2000 records, ~13 MB). We fetch the archive every six hours via a Cloudflare Worker US-egress proxy and filter locally.

Establishment number#

A unique number assigned to every USDA-inspected meat, poultry, or egg production facility. Visible on the USDA inspection legend on packaging as 'EST.' followed by digits. FSIS recall notices identify affected product by establishment number plus production date.

Nationwide distribution#

Term used on recall notices when a product was shipped to all 50 US states. Most recalls of major-brand products end up classified as nationwide. We surface nationwide vs state-specific distribution as a separate field so you can quickly see whether a recall could affect your area.

Remedy#

The corrective action the manufacturer offers to consumers who own a recalled product. Common remedies include a free repair, a free replacement, a refund, or instructions to safely dispose of the product. The remedy is always free to consumers and there's no time limit on claiming it (especially for vehicles and certain FDA Class I drug recalls).

Nitrosamine impurity#

A class of chemical impurities that can form during drug manufacturing or storage. Several nitrosamines (NDMA, NDEA, NMBA) are classified as probable human carcinogens. The FDA has recalled multiple drug classes — losartan, valsartan, metformin, ranitidine — over nitrosamine contamination since 2018.

Investigational Recall (IRF)#

A term used internally at FDA for a recall under active investigation but not yet classified into Class I/II/III. By the time a recall reaches the public openFDA endpoint it's been classified, so investigation-phase recalls don't appear in our database.

Food contact substance#

Any material intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food. FCS recalls are uncommon but happen — typically when packaging migrates a chemical into food at levels exceeding FDA limits.

Last reviewed: 2026-06-15. If you spot an inaccuracy or want a term added, the about page has contact details.