Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

18176–18200 of 50404

HighFDA (Drugs)·D-0417-2022·2022-02-02
Phenylephrine HCl Injection Recalled Due to Lack of Sterility Assurance
Edge Pharma is recalling approximately 5,335 syringes of Phenylephrine HCl Sterile Solution for Injection nationwide due to lack of assurance of sterility. The product may not meet sterility requirements for safe use.
Product
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0420-2022·2022-02-02
Edge Pharma Phenylephrine/Tropicamide Ophthalmic Solution Sterility Recall
Edge Pharma is recalling a sterile ophthalmic solution (Phenylephrine HCl/Tropicamide 2.5%/1%) because the manufacturer cannot assure sterility of the product. The recall affects 363 droptainers distributed nationwide.
Product
Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Colchester, VT 05446, NDC 05446-0815-01
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·22V050000·2022-02-02
Tesla Model Y, S, X, and 3 windshield defrosting software defect
Tesla is recalling 2020-2022 Model Y, S, X, and 3 vehicles due to a heat pump software error that reduces windshield defrosting performance. This may decrease driver visibility and increase crash risk.
Product
TESLA — TESLA MODEL S, MODEL Y, MODEL 3, MODEL X
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0619-2022·2022-02-02
Frozen Tuna Steaks Recalled for Elevated Histamine Levels
Relish Foods, Inc. dba Gourmet Fusion Foods is recalling 10 oz. individually wrapped frozen tuna steaks due to elevated histamine levels detected in FDA consumer samples.
Product
10 oz. individually wrapped frozen tuna steaks; 4 servings per bag Important: Thaw under refrigeration immediately before use. May contain bones. Product must be cooked prior to consumption KEEP FROZEN AT -18 CELSIUS OR BELOW THAW UNDER REFRIGERATION IMMEDIATELY BEFORE…
Category
Food
Distribution
1 state
HighFDA (Food)·F-0620-2022·2022-02-02
Bake Crafters Maple Waffle Chicken Sausage Recalled for Listeria Contamination Risk
Bake Crafters is recalling Maple Waffle WG Chicken Sausage due to potential Listeria monocytogenes contamination. The affected products were distributed to distribution centers in Idaho and Pennsylvania.
Product
Bake Crafters - Maple Waffle WG Chicken Sausage Packaged into cardboard containers 126 units per case
Category
Food
Distribution
2 states
HighFDA (Food)·F-0615-2022·2022-02-02
Brownie Points Schmurtle Brownies Recalled for Undeclared Peanut Allergen
Brownie Points LLC is recalling Brownie Points Schmurtle brownies because the label does not disclose peanuts as an allergen. The product was distributed across the United States in gift baskets.
Product
Brownie Points Schmurtle 2oz Packaged in food grade cellophane only used as gift basket filler - not sold individually
Category
Food
Distribution
46 states
HighCPSC·22067·2022-02-02
Games Workshop Recalls KOYO Bounca The Squig Plush Toys for Choking Hazard
Games Workshop is recalling about 2,600 KOYO Bounca The Squig Limited Edition Plush toys because the pom-poms can detach, posing a choking hazard to young children. No injuries have been reported.
Product
KOYO Bounca The Squig Limited Edition Plush toys
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0406-2022·2022-02-02
Methotrexate Injection Recalled Due to Lack of Sterility Assurance
Edge Pharma, LLC is recalling Methotrexate, USP, Sterile Solution for Injection (125 mg/5mL) due to lack of assurance of sterility. The recall affects 457 syringes distributed nationwide.
Product
Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0616-2022·2022-02-02
White Cheddar Cheese Recalled for Undeclared Wheat
G&C Food Distributors & Brokers Inc. is recalling white cheddar cheese distributed to Connecticut, New Jersey, New York, Pennsylvania, and Tennessee because the product may contain undeclared wheat, which poses a risk to consumers with wheat allergies.
Product
WHITE CHEDDAR CHEESE; INGREDIENTS: CULTURED PASTEURIZED MILK, SALT, ENZYMES; Distributed By: G&C Foods; ALLERGEN: MILK; CONTAINS: 1 BAG; Product is for Food Service Only; KEEP REFRIGERATED
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-0525-2022·2022-02-02
API ID 32 C Diagnostic Strips Recalled Due to Thermoforming Defect
Biomerieux is recalling API ID 32 C Strips due to a thermoforming defect that risks misidentification of yeasts or delayed diagnostic results. The recall affects 462 kits in Arizona, Iowa, Kentucky, and New York.
Product
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either…
Category
Medical Device
Distribution
4 states
HighCPSC·22068·2022-02-02
Maxtrade Youth ATVs Recalled for Speed and Brake Safety Defects
About 141,000 Maxtrade Coolster Mountopz youth all-terrain vehicles fail to meet federal safety standards. The ATVs exceed maximum speed limits for their intended age groups and some have parking brakes that do not prevent vehicle movement, posing a risk of serious injury or death.
Product
Maxtrade's Youth Coolster Mountopz All-Terrain Vehicles (ATVs)
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2022·2022-02-02
GE Vscan Extend ultrasound device recalled for power-on failure due to battery depletion
GE Healthcare is recalling the Vscan Extend ultrasound device because it will not power on when the battery is depleted. This occurs when the device is not turned off before battery removal or is connected to a computer without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
Category
Medical Device
Distribution
50 states
HighFDA (Food)·F-0618-2022·2022-02-02
Sugar Plum Vegetable Seasoning Blend Recalled for Undeclared Wheat
Sugar Plum Inc. is recalling Sugar Plum Vegetable Seasoning Blends Sesame Soy packets due to undeclared wheat allergen. The recall affects 2,892 units distributed to consumers in the US via online sales.
Product
Sugar Plum Vegetable Seasoning Blends Sesame Soy sold in the Veggie Lovers Cooking Kit. 1.5 oz packet. Packaged in a resealable foil bag. UPC:7 4555966500 2
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-0423-2022·2022-02-02
Betadine Sterile Ophthalmic Solution Recalled for Sterility Assurance
Edge Pharma is recalling Betadine sterile ophthalmic solution syringes due to lack of assurance of sterility. The affected product is a preservative-free, single-use ophthalmic solution distributed nationwide.
Product
Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0621-2022·2022-02-02
Sienna Chocolate Decadent Brownie Recalled for Undeclared Pecan
Dianne's Fine Desserts is recalling Sienna Chocolate Decadent Brownie because it contains undeclared pecan, which poses a risk to consumers with pecan allergies.
Product
Sienna Chocolate Decadent Brownie, Net wt. 104 oz. (6-lb. 8 oz.) 2.95 kg., UPC Codes: 8495241115; Product packed in trays covered in clear plastic, trays packed in cardboard case, 4 trays to a case. 1.4 - Unit Size: 6.75 lb tray 1.5 - Container Description: 12 by 16 inch…
Category
Food
Distribution
5 states
HighFDA (Drugs)·D-0403-2022·2022-02-02
Gemcitabine Intravesical Solution Recalled for Lack of Sterility Assurance
Edge Pharma is recalling approximately 627 syringes of Gemcitabine Sterile Intravesical Solution nationwide because the manufacturer cannot guarantee the product is sterile. The recalled batches were distributed between December 2021 and February 2022.
Product
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0614-2022·2022-02-02
Korean Sushi Recalled for Undeclared Yellow #5 Dye
Han Yang Corp. is recalling Korean Sushi (12 oz., UPC 0 72148 48043 3) distributed in Washington because the product contains undeclared Yellow #5, a food dye that may cause allergic reactions in sensitive consumers.
Product
Korean Sushi, net wt. 12 oz. UPC 0 72148 48043 3. The label is read in parts: "***KOREAN SUSHI ***Ingredients: Rice, Seaweed, Water, Salt, Eggs, Sesame Oil, Spinach, Carrot, Yellow Radish, and Sesame Seed. *** Han Yang Oriental Food Mfg. 3819 94th St. SW, Tacoma, WA 98499…
Category
Food
Distribution
1 state
HighNHTSA·22V046000·2022-02-01
Jayco Pinnacle and North Point Trailers Recalled for Tire Belt Separation
Jayco is recalling 2021-2022 Pinnacle and North Point trailers with Sailun tires that may experience belt separation, potentially causing loss of vehicle control. Free tire replacement is available through dealers.
Product
JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL PINNACLE, NORTH POINT
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V045000·2022-02-01
Tesla vehicles seatbelt warning chime may fail to activate
Tesla is recalling vehicles with seatbelt warning chimes that may not activate when the driver has not fastened their seat belt. The fix is a free over-the-air software update.
Product
TESLA — TESLA MODEL 3, MODEL Y, MODEL S, MODEL X
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22T002000·2022-02-01
Bridgestone Recalls Firestone Tires Due to Belt Separation Risk
Bridgestone is recalling specific Firestone Transforce tires because an incorrect inner liner compound could cause belt separation, increasing the risk of a crash.
Product
TIRES:TREAD/BELT recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V043000·2022-01-31
Newmar Recalls 2020-2022 Motor Homes Due to Tire Valve Stem Defect
Newmar is recalling 2020-2022 Super Star and Supreme Aire motor homes because a tire valve stem extension may be damaged, causing loss of tire pressure and increasing crash risk.
Product
NEWMAR — NEWMAR SUPREME AIRE, SUPER STAR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V040000·2022-01-28
2021-2022 Porsche Cayenne Rear Axle Alignment Safety Recall
Porsche is recalling 2021-2022 Cayenne vehicles due to potential rear axle misalignment following prior repairs. The defect may cause premature tire wear and increase crash risk.
Product
PORSCHE — PORSCHE CAYENNE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V041000·2022-01-28
2022 Forest River Vengeance Trailers Recalled for Incorrect Tire Pressure Labels
Forest River is recalling certain 2022 Vengeance Fifth Wheel trailers because the tire pressure labels may display incorrect information for the front tires, which could result in under-inflated tires and increase the risk of a crash.
Product
FOREST RIVER — FOREST RIVER VENGEANCE
Category
Vehicle
Distribution
Distributed nationwide
HighUSDA FSIS·PHA-01282022-01·2022-01-28
USDA Issues Public Health Alert for Chicken Salad Due to Listeria
USDA issued a public health alert for Simply Fresh Market chicken salad products due to possible Listeria contamination. No illnesses have been reported.
Product
FSIS Issues Public Health Alert for Ready-To-Eat Chicken Salad Products Due to Possible Listeria Contamination
Category
Food
Distribution
1 state
HighNHTSA·22V038000·2022-01-28
2013-2021 Grand Design recreational vehicles recalled for fire hazard
Grand Design RVs (2013-2021) are recalled for an improperly secured 110-volt refrigerator wire that may cause electrical arcing and fire. Dealers will inspect and replace damaged wiring at no cost.
Product
GRAND DESIGN — GRAND DESIGN SOLITUDE, MOMENTUM, REFLECTION
Category
Vehicle
Distribution
Distributed nationwide