Severity 4 of 5
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
GreenGate Fresh Cello Spinach is being recalled due to potential E. coli (EHEC) contamination. The recall involves 11 cases distributed to eight consignees across seven U.S. states.
Le Croissant Tuna Salad (5.8oz) is recalled due to undeclared milk and soy allergens. Consumers with allergies to these allergens should not consume the product.
Ford is recalling certain 2023 F-250, F-350, and F-450 Super Duty vehicles due to loose or missing steering column bolts that could cause steering column separation, increasing the risk of crashes due to loss of steering control.
Polaris is recalling about 2,900 Model Year 2022 Patriot 850 MATRYX snowmobiles because the ring gear on the primary clutch can fail, causing clutch components to come loose and creating an injury hazard. Nine failures have been reported, including one injury.
Exela Pharma Sciences recalls 8.4% sodium bicarbonate injection nationwide due to silicone particulate matter in vials. The FDA classified this Class I recall as affecting 355,220 vials.
Cardinal Health's LEADER brand Dry Eye Relief eye drops are recalled nationwide due to non-sterility concerns. FDA found insanitary conditions and positive bacterial results from environmental sampling at the manufacturing facility.
The FDA recalls 1,679 VariSoft infusion sets (Model 1002828) due to connector damage that causes improper detachment. Undetected disconnections can lead to missed insulin doses and diabetic ketoacidosis.
Rugby Laboratories' Lubricating Tears Eye Drops are being recalled nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility.
LEADER brand Lubricant Eye Drops are being recalled nationwide due to non-sterility issues. FDA testing found insanitary conditions and positive bacterial contamination at the manufacturing facility.
Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops due to non-sterility issues. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility in India.
Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results from the manufacturing facility.
Exela Pharma Sciences is recalling 38,200 vials of ELCYS (cysteine hydrochloride injection) nationwide due to the presence of silicone particulate matter.
Exela Pharma Sciences is recalling Midazolam Injectable due to silicone particulate matter contamination. Patients and healthcare providers with the affected lot should discontinue use and consult their healthcare provider.
Unomedical is recalling 8,028 VariSoft infusion sets due to a manufacturing defect that makes the connector prone to unintended disconnection, potentially leading to missed insulin doses and serious blood glucose complications.
Paradise Flavors LLC is recalling Trail Mix/Frutas Secas ice cream base because it contains undeclared allergens: milk, tree nuts, peanuts, and soy. Consumers with allergies to these ingredients should not consume the product.
Paradise Flavors LLC is recalling MAGNUM ice-cream base due to undeclared milk, tree nuts, peanuts, soy, and FD&C color additives. Consumers with allergies risk serious allergic reactions.
Paradise Flavors is recalling 86 units of frozen guava jelly ice-cream product due to undeclared milk allergen and color additives (FD&C yellow #5, yellow #8, red #40). The product was distributed only in Florida.
Paradise Flavors LLC is recalling BUBBLEGUM GUMMYBEAR frozen ice cream (4 oz pouches) due to undeclared allergens—milk and tree nuts—and an undeclared color additive (FD&C Blue #1). The product was distributed within Florida only.
Paradise Flavors LLC is recalling Orange Creamcycle frozen pops due to undeclared milk allergen and undeclared color additives. The product was distributed in Florida and may pose health risks to consumers with milk allergies.
Paradise Flavors is recalling pistachio ice cream base (4 oz pouches) distributed in Florida due to undeclared milk and tree nuts. The product also contains undeclared color additives FD&C yellow #5 and blue #1.
Paradise Flavors LLC is recalling peanut butter ice-cream base distributed in Florida due to undeclared allergens (milk, peanut, soy, and wheat) not listed on the label.
Paradise Flavors LLC is recalling 4-ounce frozen MAMEY with sweet and condensed milk due to undeclared milk allergen and undeclared color additives. The product was distributed in Florida.
Paradise Flavors LLC recalls EZQUIMAL 4 oz frozen ice-cream base due to undeclared allergens (milk, tree nuts, peanuts, soy) and color additives. Product distributed in Florida.
Paradise Flavors LLC recalls Pink Guaba ice cream mix due to undeclared milk allergen and color additives. Consumers with milk allergies should not consume this product.
Paradise Flavors LLC is recalling 318 units of Cookies And Cream frozen product (4 oz) due to undeclared allergens: milk, soy, and wheat. The product was distributed in Florida.