Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Choshiya branded menma (prepared bamboo shoots) are being recalled because the label fails to include the required 'Keep Refrigerated' statement. Improper storage of this non-shelf-stable product could lead to foodborne illness.
AKT Trading Inc. is recalling Choshiya branded Shiba Zuke Prepared Mix Vegetables (1,000 cases) because they are missing the required "Keep Refrigerated" statement on the label. Non-shelf stable vegetables could be improperly stored without this critical labeling information.
Frito-Lay is recalling 1,295 bags of Tostitos Cantina Traditional Yellow Corn Tortilla Chips because milk was not declared on the label. Affected products were distributed across 13 states.
Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex (P)2 due to the potential for cracks to form in the breathing circuit hose. This FDA Class I recall affects approximately 9,250 units distributed domestically and internationally.
Choshiya brand rakkyo zuke prepared vegetables are being recalled due to missing 'Keep Refrigerated' label statements. These non-shelf-stable vegetables may spoil if not properly refrigerated.
Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex 6 (Model MP02744) due to potential cracks forming in the breathing circuit hose. Approximately 293,660 units were distributed nationwide and internationally.
AKT Trading Inc. is recalling Choshiya branded Fukushin Zuke Prepared Mix Vegetables due to a labeling deficiency. The non-shelf-stable product is missing the required "Keep Refrigerated" statement.
AKT Trading Inc. is recalling Choshiya branded Aokappa Zuke Prepared Mix Vegetables because the product label lacks a 'Keep Refrigerated' statement, risking improper storage of non-shelf-stable vegetables.
Draeger's ID Circuit Flex 220 breathing circuit for anesthesia machines may develop cracks in the hose. The recall affects 3,325 units distributed nationwide and internationally.
AKT Trading Inc. is recalling Choshiya branded Soft Tsubozuke Prepared Mix Vegetables due to missing "Keep Refrigerated" statement on labels. Non-shelf stable vegetables lacking this statement may spoil or develop harmful bacteria if stored improperly.
Draeger, Inc. is recalling 65,150 units of the VentStar Flex 220 breathing circuit due to the potential for cracks to form in the hose. A crack could affect gas delivery during anesthesia or ventilation procedures.
Draeger, Inc. is recalling Anesthesia Circuit Kit Flex 1 devices nationwide and internationally due to potential cracks in the breathing circuit hose that conducts anesthesia gases.
Draeger is recalling the Anesthesia Circuit Kit Flex EPA due to the potential for cracks to form in the breathing circuit hose. Approximately 13,620 units have been distributed domestically and internationally. Users should discontinue use of affected units immediately.
Julie's Gorditas De Nata is being recalled because the product label fails to declare wheat as an ingredient, posing a risk to consumers with wheat allergies. The recall affects 240 units distributed to two wholesalers.
Craftmark Bakery is recalling US Foods Premium Monster Cookies due to potential plastic contamination. Consumers should not consume affected products.
Bioriginal Food & Science Corporation recalls Fresh Flax Oil OMEGA 3-6-9 due to undeclared soy lecithin. Consumers with soy allergies should not consume this product.
Stryker Corporation is recalling 182,344 units of Nasopore FD nasal dressing nationwide due to potentially breached sterile seals that may allow product contamination.
Nestle-USA recalls Lean Cuisine Butternut Squash Ravioli for potential wood-like foreign material. Approximately 50,611 cases distributed across 36 states are affected.
Stryker's Nasopore 8cm nasal dressing is being recalled because packaging seals may have bubbles indicating the sterility barrier has been breached. The recall affects 182,344 units distributed nationwide.
Stryker Corporation is recalling Nasopore nasal dressings due to defects in blister seals that may compromise sterility. Affected products may have bubbles on the seal, indicating the sterile barrier has been breached.
Stryker Corporation is recalling 182,344 units of Hemopore nasal/sinus wound dressing due to potential packaging seal defects that could compromise sterility. A bubble on the blister seal may indicate the sterile barrier has been breached.
The Coastal Companies is recalling Turkey BLT on Sourdough sandwiches because some packages contain incorrectly labeled Peanut Butter & Jelly sandwiches instead, exposing consumers to an undeclared peanut allergen.
Stryker is recalling over 182,000 Nasopore nasal dressings due to potential bubbles in the blister seal that could compromise the sterile barrier. The affected units were distributed nationwide.
CACAO BARRY Gianduja Noir chocolate product is recalled due to undeclared milk, affecting 180 cases distributed across eight states. Consumers with milk allergies should not consume this product.
Stryker Corporation recalls Otopore Cylinder outer ear wound dressing due to potential bubbles in blister seals that may breach the sterile barrier. Affected units were distributed nationwide.