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.

2351–2375 of 7439

CriticalFDA (Devices)·Z-0737-2019·2019-01-30
Draeger Medical Recalls VentStar Basic 250 Breathing Circuits Due to Assembly Error
Draeger Medical is recalling 170 units of VentStar Basic 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuiting.
Product
VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with
Category
Medical Device
Distribution
12 states
CriticalUSDA FSIS·008-2019·2019-01-28
Perdue Recalls Chicken Nuggets Due to Undeclared Milk Allergen
Perdue Foods is recalling refrigerated chicken nuggets because they contain milk, a known allergen, that is not listed on the label.
Product
PERDUE FOODS, LLC. — Perdue Foods, LLC Recalls Refrigerated Fun Shapes Chicken Breast Nuggets Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
14 states
CriticalUSDA FSIS·007-2019·2019-01-25
Harvest Food Group Recalls Chicken Fried Rice for Undeclared Milk Allergen
Harvest Food Group is recalling 47,332 pounds of chicken fried rice products because they contain milk, a known allergen, that is not declared on the label.
Product
Harvest Food Group, LLC — Harvest Food Group, Inc. Recalls Poultry Products Due to Misbranding and Undeclared Allergen
Category
Food
Distribution
2 states
CriticalUSDA FSIS·005-2019·2019-01-18
Custom Made Meals Recalls Chicken Skewers Due to Undeclared Coconut Allergen
Custom Made Meals, LLC is recalling Red Chili Orange Chicken Skewers because they contain coconut, a tree nut allergen not listed on the label.
Product
Custom Made Meals, LLC — Custom Made Meals, LLC Recalls Chicken Skewer Products Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
2 states
CriticalFDA (Drugs)·D-0372-2019·2019-01-16
Sun Pharmaceutical Recalls Vecuronium Bromide Due to Glass Particulates
Sun Pharmaceutical Industries is recalling Vecuronium Bromide for Injection because glass particles were detected in the product.
Product
VECURONIUM BROMIDE — VECURONIUM BROMIDE (VECURONIUM BROMIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0358-2019·2019-01-16
Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter
Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP due to the presence of grey rubber particulate matter in the vials.
Product
Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
Category
Drug
Distribution
Distributed nationwide
CriticalNHTSA·19V010000·2019-01-09
Mercedes-Benz Recalls Vehicles Due to Passenger Air Bag Inflator Defect
Mercedes-Benz is recalling specific 2010-2017 models because passenger air bag inflators may explode due to humidity, posing a risk of serious injury or death.
Product
MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES BENZ C300, E350, GLK350, C350
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0552-2019·2019-01-09
Medtronic StealthStation Cranial Software Recall for Biopsy Depth Gauge Error
Medtronic is recalling StealthStation Cranial and Synergy Cranial software due to an incorrect display of the Biopsy Depth Gauge that resulted in the biopsy of healthy tissue.
Product
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc.
Category
Medical Device
Distribution
51 states
CriticalNHTSA·19V008000·2019-01-09
Subaru Recalls Vehicles Due to Passenger Air Bag Inflator Explosion Risk
Subaru is recalling specific 2010-2014 models because passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.
Product
SUBARU — SUBARU OUTBACK, FORESTER, LEGACY, IMPREZA
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0821-2019·2019-01-02
Apio Recalls Eat Smart Salad Shake Ups Due to Listeria
Apio, Inc. is recalling Eat Smart Salad Shake Ups after the Canadian Food Inspection Agency detected Listeria monocytogenes in the product.
Product
Eat Smart Salad Shake Ups - Sweet Kale/Chou Frise Doux: 5.5 oz. (156 g); US UPC 7 09351-30240 4; Canadian UPC: 7 09351 30243 5. Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
Category
Food
Distribution
14 states
CriticalNHTSA·19E002000·2019-01-02
Takata Frontal Passenger Air Bag Inflator Recall for 2011 and Newer Vehicles
Takata is recalling certain frontal passenger air bag inflators in 2011 and newer vehicles registered in 22 states and D.C. due to a risk of explosion.
Product
AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE recall
Category
Vehicle
Distribution
Distributed nationwide
CriticalNHTSA·19E003000·2019-01-02
Takata Frontal Passenger Air Bag Inflator Recall for 2010+ Vehicles
Takata is recalling specific frontal passenger air bag inflators in 2010 or newer vehicles registered in 22 states due to a risk of explosion.
Product
AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE recall
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0819-2019·2019-01-02
Apio Recalls Eat Smart Salad Shake Ups Due to Listeria Risk
Apio, Inc. is recalling Eat Smart Salad Shake Ups in Avocado Ranch flavor because the Canadian Food Inspection Agency detected Listeria monocytogenes in the product.
Product
Eat Smart Salad Shake Ups - Avocado Ranch/Ranch et Avocats: 5.5 oz. (156 g); US UPC: 7 09351-30177 3; Canadian UPC: 7 09351 30195 7; Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
Category
Food
Distribution
14 states
CriticalFDA (Drugs)·D-0347-2019·2019-01-02
Phenylephrine HCl Injectable Solution Recalled for Incorrect Concentration Labeling
Advanced Pharma Inc. is recalling 225 syringes of Phenylephrine HCl injectable solution because the label incorrectly states the concentration as 10 mcg per mL instead of 100 mcg per mL.
Product
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
Category
Drug
Distribution
3 states
CriticalFDA (Food)·F-0820-2019·2019-01-02
Apio Recalls Eat Smart Salad Shake Ups Due to Listeria
Apio, Inc. is recalling specific varieties of Eat Smart Salad Shake Ups after the Canadian Food Inspection Agency detected Listeria monocytogenes.
Product
Eat Smart Salad Shake Ups - Raspberry Acai/Framboises ET: 5.5 oz. (156 g); US UPC 7 09351-30178 0; Canadian UPC: 7 09351 30196 4. Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
Category
Food
Distribution
14 states
CriticalNHTSA·19E001000·2019-01-02
Takata Frontal Passenger Air Bag Inflator Recall for Humidity-Related Explosion Risk
Takata is recalling specific frontal passenger air bag inflators that may explode due to humidity and heat, posing a risk of serious injury or death.
Product
AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE recall
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0818-2019·2019-01-02
Apio Recalls Eat Smart Salad Shake Ups Due to Listeria
Apio, Inc. is recalling specific varieties of Eat Smart Salad Shake Ups after the Canadian Food Inspection Agency detected Listeria monocytogenes.
Product
Eat Smart Salad Shake Ups - Asian Sesame/Sesame Asiatique; 5.5 oz. (156 g); UPC 7 09351-30241 1, 7 09351 30244 2 Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
Category
Food
Distribution
14 states
CriticalFDA (Drugs)·D-0360-2019·2018-12-26
Lubrisine eye drops recalled for undeclared colloidal silver and sterility issues
Results RNA, LLC is recalling Lubrisine eye drops nationwide due to lack of sterility assurance and the presence of undeclared colloidal silver.
Product
Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0775-2019·2018-12-26
Inspired Organic Sunflower Butter Recalled for Listeria monocytogenes Contamination
Lipari Foods is recalling Inspired Organic Sunflower Butter because product testing found Listeria monocytogenes. The recall covers 972 cases distributed across 15 states and Canada.
Product
Inspired Organic Sunflower Butter 16oz. plastic jar, 6 per case UPC #: 863669742526 refrigerate after opening
Category
Food
Distribution
15 states
CriticalFDA (Food)·F-0733-2019·2018-12-26
Sprout Creek Farm Raw Cows' Milk Cheese Recalled for Listeria Risk
Sprout Creek Farm is recalling four wheels of Kinkead raw cows' milk cheese due to potential Listeria monocytogenes contamination.
Product
Sprout Creek Farm Kinkead raw cows' milk cheese semi-firm savory brothy. The product is packaged with an orange label.
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-0730-2019·2018-12-26
Achdut Recalls Tahini Products Due to Potential Salmonella Contamination
Achdut is recalling specific Baron's and Galil tahini products because they may be contaminated with Salmonella. The products were distributed in New York, California, Pennsylvania, and Israel.
Product
Tahini sold under the following brand names: Baron's Tahini double pack, 454g, UPC: X000EZ2HCB; Galil whole tahini, 500g, UPC: 814968020037
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-0726-2019·2018-12-26
Marich Recalls Milk Chocolate Maltballs Due to Undeclared Macadamia Nuts
Marich Confectionery is recalling 15 lb cases of Milk Chocolate Maltballs because a customer found undeclared macadamia nuts in the shipment.
Product
Milk Chocolate Maltballs: NET Wt. 15 lbs. Item number 992 Case UPC 00797817-00992-9 Allergy Information: This product contains Wheat, milk and soy and may contain peanuts and tree nuts.
Category
Food
Distribution
23 states
CriticalFDA (Food)·F-0728-2019·2018-12-26
Achdut Recalls Raw Tahini Products Due to Salmonella Contamination Risk
Achdut is recalling specific lots of raw tahini because the product may be contaminated with Salmonella. The recall affects units distributed to New York, California, Pennsylvania, and Israel.
Product
Raw Tahini sold under the following brand names: Baron's raw Tahini, 454g, UPC: 816412010083; Soom raw Tahini 220kg (no barcode on product); Soom raw Tahini 18kg, UPC: 718088347329; Soom raw Tahini, 454g, UPC: 718088347411
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-0748-2019·2018-12-26
Bakkavor Baked Macaroni and Cheese Recalled for Undeclared Allergens
Bakkavor Foods USA Inc. is recalling Baked Macaroni and Cheese because it contains lobster, shrimp, and soy that are not listed on the label.
Product
Baked Macaroni and Cheese, NET WT 12 OZ (340g), CONTAINS: WHEAT, MILK, EGG, Produced By BAKKAVOR USA, 2700 Westinghouse Blvd. Charlotte, NC 28273, Phone: 704-522-1977, UPC 7 61088 80502 3
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-0776-2019·2018-12-26
Lipari Foods Recalls Inspired Organic Almond Butter Due to Listeria
Lipari Foods is recalling Inspired Organic Almond Butter because product testing found Listeria monocytogenes. Consumers should stop using the product.
Product
Inspired Organic Almond Butter 16oz. plastic jar, 6 per case UPC #: 863669742540 refrigerate after opening
Category
Food
Distribution
15 states