Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

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.

751–775 of 7436

CriticalFDA (Food)·F-1087-2024·2024-03-27
Don Pancho Fiesta Sauces Recalled for Listeria Monocytogenes Contamination
Reser's Fine Foods is recalling Don Pancho Fiesta 3 Pack Everything Sauce due to potential Listeria monocytogenes contamination from recalled Cotija cheese repackaged into these ready-to-eat products.
Product
Item # 407034, Don Pancho Fiesta 3 Pack Everything Sauce. Each pack consists of Cilantro Lime Crema, Baja-Style Crema, Chipotle Crema. 3/12oz glass bottles per pack, 6 packs per case. UPC on 3-pack box: 0 71117 00741 1.
Category
Food
Distribution
16 states
CriticalFDA (Food)·F-1078-2024·2024-03-27
Fresh & Ready Chicken Torta Sandwich Recalled for Listeria Contamination
Fresh & Ready Foods LLC is recalling Fresh & Ready Chicken Torta Sandwich products (use-by dates 02/03/2024–02/22/2024) due to Listeria monocytogenes contamination. Affected products were distributed to California, Nevada, Utah, and Arizona.
Product
Fresh & Ready Chicken Torta Sandwich 9 oz UPC 8290690706
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-1077-2024·2024-03-27
Fresh & Ready Ham Torta Sandwich recalled for Listeria monocytogenes contamination
Fresh & Ready Foods LLC recalled Fresh & Ready Ham Torta Sandwich (9 oz) due to possible Listeria monocytogenes contamination. The recall affects products distributed in California, Nevada, Utah, and Arizona with use-by dates February 3–22, 2024.
Product
Fresh & Ready Ham Torta Sandwich 9 oz UPC 8290690707
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-1089-2024·2024-03-27
HEB Poblano Caesar Dressing recalled for Listeria monocytogenes contamination
Reser's Fine Foods is recalling HEB Poblano Caesar Dressing due to Listeria monocytogenes contamination from repackaged Cotija cheese. The recall affects 2495 cases distributed across 16 states.
Product
FCF Item 403953, HEB Poblano Caesar Dressing, 12oz. glass bottle, 6 bottles per case. UPC 41220 94807
Category
Food
Distribution
16 states
CriticalFDA (Food)·F-1082-2024·2024-03-27
Stonewall Kitchen Gluten Free Doughnut Mix Recalled for Undeclared Wheat
Stonewall Kitchen is recalling Cinnamon Sugar Doughnut Mix (Gluten Free) with use-by dates of March 9-10, 2025, because units contain undeclared wheat. Consumers with wheat allergies or celiac disease should not consume this product.
Product
Stonewall Kitchen Cinnamon Sugar Doughnut Mix; Gluten Free; Home-Baked & Gluten Free; Net Wt. 18oz (510g); UPC: 1138131332
Category
Food
Distribution
44 states
CriticalCPSC·24169·2024-03-21
Happiness USA Roller Ball Candy Recalled Due to Choking Hazard
Twenty Four Six Foods LLC is recalling all flavors of Happiness USA Liquid Rolling Candy because the rolling ball applicator can dislodge into a child's mouth, posing a choking hazard and risk of death.
Product
Happiness USA Liquid Rolling Candy
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1050-2024·2024-03-13
Vegetarian Pia Cake Recalled for Undeclared Egg Allergen
LQNN Inc. is recalling 222,320 bags of Vegetarian Pia Cake Mung Bean Pineapple for containing undeclared egg. The product was distributed across 31 U.S. states and Canada.
Product
Vegetarian Pia Cake Mung Bean Pineapple, 14oz (400g)
Category
Food
Distribution
32 states
CriticalFDA (Food)·F-1035-2024·2024-03-13
Frios Gourmet Pops Frozen Popsicles Recalled for Undeclared Egg Allergen
Frios Gourmet Pops frozen popsicles are being recalled because they contain undeclared egg, an allergen. Consumers with egg allergies may face allergic reactions if they consume these products.
Product
Frios Gourmet Pops - Banana Pudding Popsicle 3oz frozen popsicle packaged individually in clear plastic sleeve. 48 popsicles per box. *Sold directly to end consumer via food truck
Category
Food
Distribution
17 states
CriticalFDA (Food)·F-1044-2024·2024-03-13
Vegetarian Pia Cake Taro Durian Recalled for Undeclared Egg Allergen
LQNN Inc. is recalling Vegetarian Pia Cake Taro Durian (14 oz bags) due to undeclared egg allergen. The recall affects approximately 222,320 bags distributed across 31 U.S. states and Canada.
Product
Vegetarian Pia Cake Taro Durian, 14 oz (400g)
Category
Food
Distribution
32 states
CriticalUSDA FSIS·012-2024·2024-03-10
Jen's Breakfast Burritos Recalls Ready-to-Eat Products Due to Listeria Risk
Jen's Breakfast Burritos, LLC is recalling approximately 144 pounds of ready-to-eat breakfast burritos due to possible Listeria monocytogenes contamination.
Product
Jen's Breakfast Burritos, LLC, Recalls Ready to Eat Breakfast Burrito Products Due to Possible Listeria Contamination
Category
Food
Distribution
1 state
CriticalCPSC·24147·2024-03-07
Getallfun 216-Piece 5mm Magnetic Ball Sets Recalled for Ingestion Hazard
Getallfun recalls 216-Piece 5mm Magnetic Ball Sets because they fail to meet federal toy safety standards. High-powered magnets can perforate or block the intestines if swallowed, risking serious injury or death.
Product
216-Piece 5mm Magnet Balls
Category
Consumer Product
Distribution
Distributed nationwide
CriticalCPSC·24144·2024-03-07
High-Powered Magnetic Ball Sets Recalled Due to Ingestion Hazard
Magnetic Stones Toy Creativity Development DIY Magnetic Beads (5mm) sold on Walmart.com from August 2022 through April 2023 are recalled because the magnets exceed federal toy magnet limits and pose an ingestion hazard. Consumers should stop using them immediately and contact Joybuy for return instructions.
Product
Magnetic Stones Toy Creativity Development DIY Magnetic Beads, 5mm (.2 inch)
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1123-2024·2024-03-06
Medline Surgical Kits Recalled for Potential Sterility Failure
Medline Industries is recalling 533 units of gynecological laparoscopy kits and trays manufactured with Nurse Assist irrigation and saline components due to potential lack of sterility. The affected products were distributed nationwide in the U.S. and internationally.
Product
Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1091-2024·2024-03-06
Medline Tracheostomy Care Kits Recalled for Non-Sterile Component Solutions
Medline Industries is recalling care and cleaning kits for tracheostomy and stomas due to component solutions that may not be sterile. The affected kits contain Nurse Assist-manufactured saline and irrigation solutions distributed in the U.S., Puerto Rico, Canada, UAE, and Panama.
Product
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1070-2024·2024-03-06
VOCSN Pediatric breathing package spiral wrap detachment risk during ventilation
Ventec Life Systems recalls VOCSN Patient Breathing Packages because the spiral wrap may detach during ventilation, compromising the breathing circuit and creating a risk of serious injury or death, especially for ventilator-dependent patients.
Product
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ven
Category
Medical Device
Distribution
8 states
CriticalFDA (Devices)·Z-1102-2024·2024-03-06
Surgical kits and trays recalled due to lack of sterility
Medline Industries is recalling over 3,200 surgical kits and trays containing components that may lack sterility. The recalled products could pose infection risk to patients if used during surgical procedures.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f) GASTRI
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1007-2024·2024-03-06
Ready Pac Bistro Queso Crunch Salad Kit recalled for Listeria contamination risk
Ready Pac Bistro Queso Crunch Salad Kit (UPC 077745256139) is recalled due to potential Listeria monocytogenes contamination. Affected products have use-by dates between January 13 and February 18, 2024.
Product
Ready Pac Bistro Queso Crunch Salad Kit 24 oz. UPC 077745256139
Category
Food
Distribution
21 states
CriticalFDA (Devices)·Z-1113-2024·2024-03-06
Medline Medical Kits Recalled Due to Potential Lack of Sterility
Medline is recalling approximately 3,900 medical device kits and trays nationwide due to potential sterility failures in irrigating solution components. The affected products may not be sterile, creating a risk of infection.
Product
Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518H; e) KIT ULTRASOUND PIV START, REF DYNDV2445;
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1010-2024·2024-03-06
Sargento Parmesan Cheese Products Recalled for Listeria Monocytogenes Contamination
Sargento is recalling 1,791 cases of Parmesan cheese products distributed to 15 states due to potential Listeria monocytogenes contamination.
Product
Parmesan cheese packaged in the following configurations: 1. Sargento Fresh Grated Parmesan Cheese Pack Size 500/0.5 oz. Material #10000278, UPC 46100348659. 2. Sargento Part #10132 Fancy Shredded Parmesan Cheese Pack Size 500/0.5 oz. Material #10000284, UPC 4610033499
Category
Food
Distribution
15 states
CriticalFDA (Devices)·Z-1136-2024·2024-03-06
Centurion LVAD Maintenance Kits Recalled for Potential Sterility Failure
Medline Industries is recalling Centurion LVAD maintenance kits and driveline management trays due to sterility concerns in irrigation solution components from Nurse Assist. The solutions may be non-sterile and could pose infection risks.
Product
Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM, REF DM600; d) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; e) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; f
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1011-2024·2024-03-06
Sargento Fancy Shredded Swiss Cheese Recalled for Listeria Contamination
Sargento Foods is recalling 1,143 cases of Fancy Shredded Swiss Cheese due to potential Listeria monocytogenes contamination. The affected products were distributed across 15 US states.
Product
Swiss cheese packaged in the following configurations: 1. Sargento Fancy Shredded Swiss Cheese, Pack Size 400/1 oz. Net Wt 25.000 lbs. Material #10000390, UPC 46100349816. 2. Sargento Fancy Shredded Swiss Cheese, Pack Size 500/0.5 oz. Net Wt 15.625 Material #100010
Category
Food
Distribution
15 states
CriticalFDA (Food)·F-1000-2024·2024-03-06
ELV Alipotec tejocote supplement recalled due to toxic yellow oleander contamination
World Green Nutrition's ELV Alipotec tejocote supplement contains toxic yellow oleander instead of the labeled ingredient. FDA Class I recall affects approximately 113,500 units.
Product
ELV ALIPOTEC brand MEXICAN TEJOCOTE ROOT SUPPLEMENT PIECES (RAIZ DE TEJOCOTE MEXICANO SUPLEMENTO EN TROZOS), NET. WT, 0.3 0Z (7g)
Category
Food
Distribution
8 states
CriticalFDA (Devices)·Z-1120-2024·2024-03-06
Medline wound care trays recalled due to sterility defect
Medline Industries is recalling Wound Care Trays due to potential lack of sterility in solution components. The recall affects 72,624 units distributed nationwide and internationally.
Product
Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1081-2024·2024-02-28
Surgical ocular pack kits recalled due to saline sterility assurance loss
Windstone Medical Packaging is recalling 80 Aligned Medical Solutions ocular pack surgical kits because sterility of the included saline cannot be guaranteed.
Product
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Category
Medical Device
Distribution
3 states
CriticalFDA (Devices)·Z-1046-2024·2024-02-28
Dover Foley catheter kits recalled due to defective supplier components
Cardinal Health is recalling Dover brand Foley catheter kits due to components recalled by supplier Nurse Assist. Approximately 435,060 units were distributed to the US, Europe, Japan, and Latin America.
Product
Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R, DRAIN TUBE, PREP TRAY, 30 ML
Category
Medical Device
Distribution
0 states