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.

1526–1550 of 29080

SevereFDA (Drugs)·D-0503-2025·2025-07-09
Lidocaine HCL Sterile Injection recalled for sterility assurance concerns
Tailstorm Health INC is recalling Lidocaine HCL Sterile Injection (20 mg/mL) due to FDA inspection findings of concerns with the sterile manufacturing process. The recalled product is distributed nationwide.
Product
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2014-2025·2025-07-09
Servo-n ventilators may measure patient circuit compliance inaccurately
The Servo-n Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 7,688 units affected.
Product
Servo-n Ventilator System. Model Number: 6694800.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·H-0190-2025·2025-07-09
Harris Teeter ZENSHI Handcrafted Sushi Spicy Roll Shrimp Recall
Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Spicy Roll - Shrimp 10pc (Brown Rice) due to possible Salmonella contamination from recalled cucumbers used in the product.
Product
ZENSHI HANDCRAFTED SUSHI Spicy Roll - Shrimp 10pc (Brown Rice) Net Wt. 7.1oz UPC 0 23012 94317 2
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0201-2025·2025-07-09
Zenshi yuzu teriyaki tuna roll trays made with recalled cucumbers
Zenshi Handcrafted Sushi Yuzu Teriyaki Tuna Roll is being recalled because it was made with cucumbers recalled over possible Salmonella. 5,409 trays are affected.
Product
ZENSHI HANDCRAFTED SUSHI Yuzu Teriyaki Tuna Roll 10pc Net Wt. 3oz UPC 0 23012 95033 0
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0194-2025·2025-07-09
Zenshi summer roll sushi trays made with recalled cucumbers
Zenshi Handcrafted Sushi Summer Roll is being recalled because it was made with cucumbers recalled over possible Salmonella. 5,776 trays are affected.
Product
ZENSHI HANDCRAFTED SUSHI Summer Roll 2pc Net Wt. 7oz UPC 0 23012 94325 7
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0118-2025·2025-07-09
Sabores Bakery four milk mousse cups carry undeclared allergens
Sabores Fit Bakery Four Milk Mousse, 8 oz cups, is being recalled because the label does not declare milk, eggs, soy, wheat and tree nuts. 64 cups are affected.
Product
Four Milk Mousse, NET WT 8 OZ (230g), Sabores Bakery, Plastic Cups, 3.5-inch-wide x 3.75 in high, Keep refrigerated, PRODUCED EXCLUSIVELY BY: SABORES FIT BAKERY LLC. ORLANDO, FL 32836, UPC 7 35816 97176 2
Category
Food
Distribution
1 state
SevereFDA (Food)·H-0176-2025·2025-07-09
Zenshi mango crunchy dragon roll trays used recalled cucumbers
Zenshi Handcrafted Sushi Mango Crunchy Dragon Roll is being recalled over cucumbers recalled for possible Salmonella. 1,083 trays are affected.
Product
ZENSHI HANDCRAFTED SUSHI Mango Crunchy Dragon Roll 10pc Net Wt. 10.4oz UPC 0 23012 94498 8
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0136-2025·2025-07-09
Zenshi salmon cream cheese roll trays used recalled cucumbers
Zenshi Handcrafted Sushi Cream Cheese Roll with salmon is being recalled over cucumbers recalled for possible Salmonella. 5,350 trays are affected.
Product
ZENSHI HANDCRAFTED SUSHI Cream Cheese Roll - Salmon 10pc Net Wt 7.1oz UPC 0 23012 94275 5
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0195-2025·2025-07-09
ZENSHI Handcrafted Sushi Ultimate Chili Roll Salmonella Recall
Harris Teeter is recalling ZENSHI Handcrafted Sushi Ultimate Chili Roll—Salmon (10pc, 10.4oz) because cucumbers used in the sushi were recalled due to possible Salmonella contamination.
Product
ZENSHI HANDCRAFTED SUSHI Ultimate Chili Roll - Salmon 10pc Net Wt. 10.4oz UPC 0 23012 94326 4
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0193-2025·2025-07-09
Zenshi spring sushi wrap trays made with recalled cucumbers
Zenshi Handcrafted Sushi Spring Sushi Wrap is being recalled because it was made with cucumbers recalled over possible Salmonella. 3,671 trays are affected.
Product
ZENSHI HANDCRAFTED SUSHI Spring Sushi Wrap 10pc Net Wt. 10.5oz UPC 0 23012 95062 3
Category
Food
Distribution
8 states
SevereFDA (Devices)·Z-2041-2025·2025-07-09
HardyCHROM CRE Culture Medium Recalled for Quality Control Failure
Hardy Diagnostics is recalling HardyCHROM CRE culture medium (Catalog No. G323) distributed across 22 US states and Puerto Rico. The product failed quality control testing due to breakthrough growth of Klebsiella pneumoniae.
Product
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Category
Medical Device
Distribution
22 states
SevereFDA (Food)·H-0172-2025·2025-07-09
Zenshi hybrid Ni sushi platters made with recalled cucumbers
Zenshi Handcrafted Sushi Hybrid Ni Platter is being recalled because it was made with cucumbers recalled over possible Salmonella. 7 trays are affected.
Product
ZENSHI HANDCRAFTED SUSHI Hybrid Ni Platter 31pc Net Wt. 33.1oz UPC 0 23012 94258 8
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0196-2025·2025-07-09
Zenshi ultimate chili shrimp roll trays made with recalled cucumbers
Zenshi Handcrafted Sushi Ultimate Chili Roll with shrimp is being recalled because it was made with cucumbers recalled over possible Salmonella. 162 trays are affected.
Product
ZENSHI HANDCRAFTED SUSHI Ultimate Chili Roll - Shrimp Net Wt. 10.4oz UPC 0 23012 95038 5
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0162-2025·2025-07-09
ZENSHI HANDCRAFTED SUSHI Happy Heart Platter recalled for possible Salmonella
Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Happy Heart Platter #1 (Rainbow Dragon Seaside) due to possible Salmonella contamination from recalled cucumbers used in the product.
Product
ZENSHI HANDCRAFTED SUSHI Happy Heart Platter #1 (Rainbow Dragon Seaside) 23pc Net Wt. 19.2oz UPC 0 23012 94360 8
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0207-2025·2025-07-09
Fruit and Vegetable Trays Recalled for Potential Salmonella Contamination
JFE Franchising Inc. is recalling multiple fruit and vegetable tray products because cucumbers may be contaminated with Salmonella. The affected products were distributed in seven states with a sell-by date of May 20, 2025.
Product
Fruit & Vegetable Tray - 64 oz 63912394047 Mixed Melon, Cucumbers & Tajin - 18oz 63912394007 Watermelon & Cucumber w/ Tajin - 18oz 63912394036 Small Vegetable Tray - 19.5 oz 63912388045 Small Party Tray with Dip - 19 oz 63912388046 Large Vegetable Tray - 42 oz 63912
Category
Food
Distribution
7 states
SevereFDA (Food)·H-0127-2025·2025-07-09
Harris Teeter ZENSHI Handcrafted Sushi Chef Sampler recalled for Salmonella
Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Chef Sampler A#4 (15pc, 14.6oz) because the cucumbers used in the product were recalled due to possible Salmonella contamination.
Product
ZENSHI HANDCRAFTED SUSHI Chef Sampler A#4 (Chili, Rainbow, Crunchy Dragon) 15pc Net Wt. 14.6oz (414g) UPC 0 23012 94332 5
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0132-2025·2025-07-09
Zenshi chile serrano roll trays made with recalled cucumbers
Zenshi Handcrafted Sushi Chile Serrano Roll is being recalled because it was made with cucumbers recalled over possible Salmonella. 324 trays are affected.
Product
ZENSHI HANDCRAFTED SUSHI Chile Serrano Roll 10pc Sushi Net Wt. 9.1oz UPC 0 23012 94032 4
Category
Food
Distribution
8 states
SevereFDA (Drugs)·D-0499-2025·2025-07-09
Bupivacaine HCL Sterile Injection Recalled for Sterility Assurance Concerns
Tailstorm Health Inc. is recalling bupivacaine HCL sterile injection vials nationwide due to FDA inspection findings regarding concerns with the sterile manufacturing process.
Product
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·H-0198-2025·2025-07-09
Harris Teeter ZENSHI HANDCRAFTED SUSHI Vegetable Roll recalled for Salmonella
Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Vegetable Roll 10pc trays due to possible Salmonella contamination from recalled cucumbers used in the product.
Product
ZENSHI HANDCRAFTED SUSHI Vegetable Roll 10pc Net Wt. 7.1oz UPC 0 23012 94327 1 & UPC 0 23012 95151 1
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0120-2025·2025-07-09
Zenshi arroz picante imitation crab rolls used recalled cucumbers
Zenshi Handcrafted Sushi Arroz Picante Roll with imitation crab is being recalled over cucumbers recalled for possible Salmonella. 202 trays are affected.
Product
ZENSHI HANDCRAFTED SUSHI Arroz Picante Roll - Imitation Crab 10pc Net Wt. 10.3oz (292g) UPC 0 23012 94034 8
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0147-2025·2025-07-09
Zenshi crunchy shrimp tempura roll trays made with recalled cucumbers
Zenshi Handcrafted Sushi Crunchy Shrimp Tempura Roll is being recalled over cucumbers recalled for possible Salmonella. 13,170 trays are affected.
Product
ZENSHI HANDCRAFTED SUSHI Crunchy Shrimp Tempura Roll 10pc Net Wt 9.1oz UPC 0 23012 94289 2
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0140-2025·2025-07-09
Harris Teeter ZENSHI Handcrafted Sushi Crunchy Dragon Roll Recalled for Salmonella
Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Crunchy Dragon Roll (10pc, 9.6oz) due to possible Salmonella contamination from recalled cucumbers used in the product.
Product
ZENSHI HANDCRAFTED SUSHI Crunchy Dragon Roll 10pc Net Wt. 9.6oz UPC 0 23012 94461 2
Category
Food
Distribution
8 states
SevereFDA (Devices)·Z-2015-2025·2025-07-09
Servo-u MR Ventilator System inaccurate patient circuit compliance measurement
Servo-u MR Ventilator System (Model 6888800) may measure patient circuit compliance inaccurately due to incorrect pre-use leakage testing and incorrect active humidifier use.
Product
Servo-u MR Ventilator System. Model Number: 6888800.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·H-0145-2025·2025-07-09
Zenshi crunchy shrimp roll trays made with recalled cucumbers
Zenshi Handcrafted Sushi Crunchy Roll with shrimp is being recalled over cucumbers recalled for possible Salmonella. 6,523 trays are affected.
Product
ZENSHI HANDCRAFTED SUSHI Crunchy Roll - Shrimp 10pc Net Wt 10.0oz UPC 0 23012 95042 2
Category
Food
Distribution
8 states
SevereFDA (Food)·H-0171-2025·2025-07-09
Zenshi hybrid mini sushi platters made with recalled cucumbers
Zenshi Handcrafted Sushi Hybrid Mini Platter is being recalled because it was made with cucumbers recalled over possible Salmonella. 249 trays are affected.
Product
ZENSHI HANDCRAFTED SUSHI Hybrid Mini Platter 22pc Net Wt. 26.9oz UPC 0 23012 94257 1
Category
Food
Distribution
8 states