Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

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.

3026–3050 of 4878

SevereFDA (Drugs)·D-0131-2023·2023-01-25
Daptomycin for Injection Recalled Due to Incorrect Labeling Dosage
Accord Healthcare is recalling Daptomycin for Injection labeled as 350 mg/vial but containing 500 mg/vial vials. The labeling error poses a dosing risk to patients.
Product
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0301-2023·2023-01-25
Dough Ball Products Recalled for Undeclared Milk Allergen
Sysco Merchandising and Supply is recalling Greco and Sons Dough Room pizza dough products due to undeclared milk allergen. Consumers with milk allergies should not consume these products.
Product
Greco and Sons Dough Room Product No. 12 Vic's Pizza 10 oz.; Greco and Sons Dough Room Product No. 17 Vic's Pizza 20 oz.
Category
Food
Distribution
6 states
SevereFDA (Food)·F-0294-2023·2023-01-25
Sysco Greco and Sons Dough Products Recalled for Undeclared Milk Allergen
Sysco Merchandising and Supply is recalling Greco and Sons dough products sold in six states due to undeclared milk allergen. The recall affects approximately 2,325 cases with Best if Used By dates between December 1, 2022 and June 1, 2023.
Product
Greco and Sons Dough Room Product No. 28 Stefano 12 oz.; Greco and Sons Dough Room Product No. 29 Stefano 20 oz.; Greco and Sons Dough Room Product No. 30 Stefano 26 oz.; Greco and Sons Dough Room Product No. 36 Stefano 24 oz.; Greco and Sons Dough Room Product No. 35 Stefano 15
Category
Food
Distribution
6 states
SevereFDA (Food)·F-0295-2023·2023-01-25
Greco and Sons Dough Room Garlic Knots recalled for undeclared milk allergen
Sysco Merchandising and Supply is recalling Greco and Sons Dough Room Garlic Knots due to undeclared milk allergen. Affected cases were distributed across six states with best-if-used-by dates between December 1, 2022, and June 1, 2023.
Product
Greco and Sons Dough Room Product No. 65 Garlic Knots 180/CS
Category
Food
Distribution
6 states
SevereFDA (Food)·F-0290-2023·2023-01-25
Alfalfa Sprouts Recalled Due to Potential Salmonella Contamination
Sun Sprouts Alfalfa Sprouts packaged in 4 oz clamshells and 2.5 lb boxes have been recalled due to potential Salmonella contamination. The affected products were sold to distributors and retailers in Nebraska, Kansas, and Iowa.
Product
Sun Sprouts Alfalfa Sprouts packaged in 4 oz plastic clamshell, 6/4 oz or 12/4 oz containers per case; Sun Sprouts Alfalfa Sprouts packaged in 2.5lb plastic lined box.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0297-2023·2023-01-25
Greco and Sons dough products recalled for undeclared milk allergen
Sysco Merchandising and Supply recalls Greco and Sons dough products containing undeclared milk allergen. Affected products were distributed to food service locations in six states.
Product
Greco and Sons Dough Room Product No. 92 House of 1000 10 oz.; Greco and Sons Dough Room Product No. 81 House of 1000 15 oz.; Greco and Sons Dough Room Product No. 37 Handlebar 27 oz.; Greco and Sons Dough Room Product No. 38 Handlebar 23 oz.; Greco and Sons Dough Room Product No
Category
Food
Distribution
6 states
SevereFDA (Food)·F-0293-2023·2023-01-25
Greco and Sons Dough Room Products Recalled for Undeclared Milk Allergen
Sysco Merchandising and Supply is recalling multiple Greco and Sons Dough Room products distributed in six states due to undeclared milk allergen. Consumers with milk allergies should not consume these products.
Product
Greco and Sons Dough Room Product No. 333 PUB DOUGH 9 oz.; Greco and Sons Dough Room Product No. 88 Christopher's 14 oz.; Greco and Sons Dough Room Product No. 84 Christopher's 20 oz.; Greco and Sons Dough Room Product No. 86 Christopher's 36 oz.; Greco and Sons Dough Room Produ
Category
Food
Distribution
6 states
SevereFDA (Devices)·Z-0885-2023·2023-01-25
Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly
The Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly when blood enters the device through a compromised balloon catheter during use.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-08
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0882-2023·2023-01-18
Philips Trilogy 100 Ventilator Foam May Separate and Block Air Inlet
Silicone sound abatement foam in some Philips Trilogy 100 ventilators may separate and block the air inlet, potentially reducing delivered therapy volume or pressure and causing device alarms.
Product
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0908-2023·2023-01-18
Philips Fetal Spiral Electrode may break off during labor monitoring
Philips is recalling fetal spiral electrodes used for labor monitoring because the spiral tip can break off during use, requiring surgery to remove the fragment from the newborn.
Product
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0773-2023·2023-01-18
RSDL Reactive Skin Decontamination Lotion Kit recalled for leaking packets
Emergent Protective Products USA Inc recalls RSDL Decontamination Lotion Kits due to complaints of leaking packets. Approximately 4,000 units were distributed to Virginia, Canada, and Switzerland.
Product
RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0883-2023·2023-01-18
Philips Trilogy 100 and 200 Ventilators Recalled for Foam Separation Risk
Silicone foam in some Philips Trilogy 100 and 200 ventilators may separate and block the air inlet, potentially reducing therapy delivery. This is an FDA Class I recall.
Product
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0877-2023·2023-01-18
Mahurkar Dialysis Catheters Recalled Due to Leaking Hub Defect
Covidien LP is recalling Mahurkar dialysis catheters for a potential leaking condition in the hub that may cause unanticipated fluid return during use. Over 359,000 units are affected worldwide.
Product
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm, Pre-Curved, Kit - Model No. 8888135133; 13.5cm, Straight
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0884-2023·2023-01-18
Philips Garbin Ventilator Foam May Separate, Blocking Air Intake
Silicone foam in some Philips Garbin Ventilators may separate and block the air inlet, reducing therapy volume and causing alarms. Nine units are affected.
Product
Philips Garbin Ventilator, Model Number 1058180B
Category
Medical Device
Distribution
Distributed nationwide
SevereCPSC·23091·2023-01-12
BISSELL Cordless Wet Dry Vacuums Recalled for Fire Hazard
BISSELL Cordless Multi-Surface Wet Dry Vacuums (models 2551, 2551W, and 25519) are recalled because the battery pack circuit board can overheat and catch fire. The company has received 66 reports of smoking and burning odor, including five fires and one burn injury.
Product
BISSELL® Cordless Multi-Surface Wet Dry Vacuums Models 2551, 2551W and 25519
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·22V921000·2023-01-12
2021 Porsche Taycan Suspension Strut Defect May Cause Loss of Vehicle Control
A retaining ring on the 2021 Porsche Taycan's suspension strut may come loose, causing loss of vehicle control and increasing crash risk. Repairs will be provided free by Porsche dealers.
Product
PORSCHE — 2021 PORSCHE TAYCAN
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-0214-2023·2023-01-11
Cranberry Sweets Meltaway Recalled for Undeclared Peanut Allergen
Cranberry Sweets & More Inc is recalling Peanut Butter Meltaway chocolates mislabeled as Mint Meltaways. The product contains undeclared peanut, a major food allergen, posing risk to allergic consumers.
Product
Recalled Meltaways product is packaged in clear cellophane bags, net wt. 4oz and 8 oz. and has no UPC. The front label is read Mint Meltaways, Cranberry Sweets and more, Coos Bay, OR 97402. The back label is read Heirloom Mint Meltaways, Ingredients: Milk Chocolate (***soy lecit
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-0220-2023·2023-01-11
Three Gold Coins Dried Mushrooms Recalled for Salmonella Contamination
Tai Phat Wholesalers LLC is recalling Three Gold Coins Dried Mushrooms due to Salmonella contamination. The product was distributed to multiple states including Florida, New York, and Pennsylvania.
Product
Three Gold Coins, Dried Mushrooms (01052) Nam Meo Nguyen Tai S- 50x2.5 oz
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0218-2023·2023-01-11
Three Gold Coins Dried Mushrooms Recalled for Salmonella Contamination
Three Gold Coins brand dried mushrooms have been recalled due to Salmonella contamination. Approximately 341.2 cases were distributed across 15 U.S. states.
Product
Three Gold Coins, Dried Mushrooms Sliced (01051) Nam Meo Soi S- 50x2.5 oz
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0219-2023·2023-01-11
Three Gold Coins Dried Mushrooms Recalled Due to Salmonella Contamination
Three Gold Coins Dried Mushrooms Sliced have been recalled due to Salmonella contamination. Affected product was distributed across 15 U.S. states.
Product
Three Gold Coins, Dried Mushrooms Sliced (01276) Nam Meo Soi L- 24x10.5 oz.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0216-2023·2023-01-11
Power Life Protein Powder Recalled Due to Undeclared Milk
Power Life High Impact Plant Protein in chocolate flavor is recalled because the product label does not declare milk as an ingredient, creating a serious allergic reaction risk for milk-allergic consumers.
Product
Power Life by Tony Horton High Impact Plant Protein Chocolate Flavor NET WT 446 G (15.7 OZ) Ingredients: Vegan Protein Mix (pumpkin, sunflower, flax)(as ProteoSMART), Mung Bean Protein, myHMB (Calcium Beta-hydroxy-Beta-Methlbutyrate), Alkalized Cocoa Powder, Pea Protein Powder,
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0221-2023·2023-01-11
Dried mushrooms recalled due to Salmonella contamination
Three Gold Coins dried mushrooms have been recalled due to Salmonella contamination. Consumers should not consume the product.
Product
Three Gold Coins, Dried Mushrooms (01277) Nam Meo Nguyen Tai L- 24x10.5 oz
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0224-2023·2023-01-11
Culvers Tartar Sauce 2 oz Cups Recalled for Undeclared Allergens
Culvers tartar sauce is being recalled because it contains undeclared fish, soy, and milk allergens. Food service locations should remove the product immediately.
Product
Culvers Tartar Sauce 2 oz. plastic cups
Category
Food
Distribution
0 states
SevereNHTSA·21V837000·2023-01-10
2020-2023 IC Bus School Buses Recalled for Engine Shut Down Risk
Navistar is recalling 2020-2023 IC Bus CESB school buses due to an engine control module defect that may cause unexpected engine shutdown while driving, increasing the risk of crashes and emergency evacuation situations.
Product
IC BUS — 2023 IC BUS CESB
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22V501000·2023-01-07
2022 Toyota Tundra rear camera software defect increases crash risk
The 2022 Toyota Tundra with Panoramic View Monitor may display front camera footage instead of rear camera when in reverse, reducing rear visibility and increasing crash risk. Toyota will reprogram the parking assist system free of charge.
Product
TOYOTA — 2022 TOYOTA TUNDRA
Category
Vehicle
Distribution
Distributed nationwide