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.

5651–5675 of 7443

CriticalFDA (Devices)·Z-1228-2014·2014-04-02
Thoratec HeartMate II System Controller Recalled Due to Injury and Death Reports
Thoratec is recalling HeartMate II System Controllers because serious injuries and deaths occurred when patients switched from primary to backup controllers.
Product
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1227-2014·2014-04-02
Thoratec HeartMate II Implant Kit Recalled Due to Controller Switching Injuries
Thoratec is recalling HeartMate II Implant Kits because serious injuries and deaths occurred when patients switched from primary to backup System controllers.
Product
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1230-2014·2014-04-02
Thoratec HeartMate II Pocket Controllers Recalled Due to Reported Deaths
Thoratec is recalling HeartMate II Pocket Controllers because serious injuries and deaths were reported when patients switched from primary to backup controllers.
Product
Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1694-2014·2014-04-02
Kinnikinnick Waffles Recalled for Undeclared Milk Allergen
World Pure Foods Wholesalers is recalling Kinnikinnick Original Homestyle Waffles sold in Michigan due to undeclared milk.
Product
Kinnikinnick Original Homestyle Waffles 210 g/7.4 oz Cardboard Box UPC 620133001981
Category
Food
Distribution
1 state
CriticalFDA (Food)·F-1702-2014·2014-04-02
Dole Italian Blend Salad Recalled for Listeria Monocytogenes
Dole Fresh Vegetables Inc is recalling Italian Blend Salad due to a positive Listeria Monocytogenes test by the Canadian Food Inspection Agency.
Product
Italian blend Salad (Romaine Lettuce and Radicchio) packaged under the following brand names: Dole Italian Blend, (UPC 7143000819); Fresh Selections Italian Style Blend (Kroger) (UPC 1111091045); Little Salad Bar Italian Salad, (UPC 4149811014); Marketside Italian Style Sala
Category
Food
Distribution
15 states
CriticalFDA (Food)·F-1696-2014·2014-04-02
Kinnikinnick Panko Bread Crumbs Recalled for Undeclared Milk
World Pure Foods Wholesalers is recalling Kinnikinnick Panko Style Bread Crumbs sold in Michigan due to undeclared milk.
Product
Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3
Category
Food
Distribution
1 state
CriticalFDA (Drugs)·D-1158-2014·2014-03-26
Baxter Recalls Clinimix E Bags Due to Particulate Matter
Baxter Healthcare is recalling 14,574 bags of Clinimix E IV solution found to contain particulate matter, including wood, sodium citrate, and dextrose.
Product
CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1212-2014·2014-03-26
Abbott Recalls FreeStyle Flash Blood Glucose Meters Due to Inaccurate Results
Abbott Diabetes Care is recalling FreeStyle Flash Blood Glucose Monitors because they may produce inaccurate low blood glucose readings when used with specific test strips.
Product
FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions wi
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1160-2014·2014-03-26
Baxter Recalls Clinimix IV Bags Due to Particulate Matter
Baxter Healthcare is recalling 7,388 bags of Clinimix 5/15 sulfite-free IV solution because they contain particulate matter, including wood, sodium citrate, and dextrose.
Product
CLINIMIX — CLINIMIX (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1677-2014·2014-03-26
Starbucks Greek Yogurt Parfait Recalled for Undeclared Egg
Gretchen's Shoebox Express is recalling Starbucks brand Greek Yogurt Raspberry & Lemon Parfait cups due to undeclared egg.
Product
Starbuck's brand Greek Yogurt Raspberry & Lemon Parfait; 6.1 oz single serve plastic cups, sold as individual unit. Finished product label is affixed to the top of the cup; nutritional labeling is located on the side of the cup, along with the printed code which appears on a whit
Category
Food
Distribution
2 states
CriticalFDA (Drugs)·D-1170-2014·2014-03-26
Silver Sword capsules recalled for undeclared sildenafil ingredient
Fabscout Entertainment is recalling Silver Sword capsules because FDA analysis found they contain sildenafil, an undeclared active pharmaceutical ingredient.
Product
Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1169-2014·2014-03-26
Clalis capsules recalled for undeclared sildenafil ingredient
Fabscout Entertainment, Inc. is recalling Clalis capsules because FDA analysis found they contain sildenafil, an undeclared active pharmaceutical ingredient.
Product
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1163-2014·2014-03-26
Baxter Recalls Sodium Chloride IV Solutions Due to Particulate Matter
Baxter Healthcare is voluntarily recalling 0.9% Sodium Chloride Injection IV solutions due to the presence of particulate matter, including fibers and plastic particles.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1630-2014·2014-03-19
Elite Spice Recalls Chipotle Nut Seasoning Due to Salmonella Risk
Elite Spice Inc. is recalling 500 lbs of Chipotle Nut Seasoning because it may be contaminated with Salmonella. The product was distributed to nine states.
Product
Chipotle Nut Seasoning, Elite Code # 38113A2, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-1654-2014·2014-03-19
Pecan Shed Plain Chocolate Fudge Recalled for Undeclared Soy and Milk
Pecan Shed is recalling Plain Chocolate Fudge because it contains undeclared soy and milk allergens. The product was sold in multiple states and online.
Product
Plain Chocolate Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
Category
Food
Distribution
10 states
CriticalFDA (Drugs)·D-1154-2014·2014-03-19
CTV Best Group Recalls BEST Slim Weight Loss Pills
CTV Best Group is recalling BEST Slim weight loss pills because they contain the undeclared drug sibutramine, making them unapproved new drugs.
Product
BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle, Distributed by CTV Best Group Inc., P.O. Box 956452, Duluth, GA 30095.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1156-2014·2014-03-19
FDA Recalls Dextrose Vials Due to Mold Contamination
Specialty Medicine Compounding Pharmacy is recalling 50% Dextrose vials after mold was found in the product. The recall affects 1,000 vials distributed in Michigan.
Product
Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Category
Drug
Distribution
1 state
CriticalFDA (Food)·F-1655-2014·2014-03-19
Pecan Shed Recalls Butter Pecan Fudge Due to Undeclared Allergens
Pecan Shed is recalling Butter Pecan Fudge because the product contains undeclared soy, milk, and pecans. The fudge was sold in retail stores and online to customers in multiple states.
Product
Butter Pecan Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-1664-2014·2014-03-19
Pecan Shed Recalls Divinity with Pecans Fudge for Undeclared Allergens
Pecan Shed is recalling Divinity with Pecans Fudge because the product contains undeclared soy, milk, and pecans. The fudge was sold in retail stores and online to customers in multiple states.
Product
Divinity with Pecans Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-1629-2014·2014-03-19
Elite Spice Recalls Jalapeno Nut Seasoning Due to Salmonella Risk
Elite Spice Inc. is recalling 500 lbs of Jalapeno Nut Seasoning because it may be contaminated with Salmonella. The product was distributed to nine states for further manufacturing.
Product
Jalapeno Nut Seasoning, Elite Code # 35076A2, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-1656-2014·2014-03-19
Pecan Shed Recalls Turtle Fudge Due to Undeclared Allergens
Pecan Shed is recalling Special Turtle Fudge because it contains undeclared soy, milk, and pecans. The product was sold in-store and online to customers in nine states and Washington DC.
Product
Pecan Shed Special Turtle Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-1665-2014·2014-03-19
Pecan Shed Recalls Fudge Due to Undeclared Allergens Soy, Pecans, and Milk
Pecan Shed is recalling Sucrose Free Chocolate Pecan fudge because it contains undeclared soy, pecans, and milk, posing a risk to allergic consumers.
Product
Sucrose Free Chocolate Pecan; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-1659-2014·2014-03-19
Pecan Shed Recalls Tiger Fudge Due to Undeclared Allergens
Pecan Shed is recalling Tiger Fudge because it contains undeclared soy, milk, and peanuts. The product was sold in multiple states and online.
Product
Tiger Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-1663-2014·2014-03-19
Pecan Shed Recalls Pumpkin Pie Fudge Due to Undeclared Allergens
Pecan Shed is recalling Pumpkin Pie with Pecans Fudge because it contains undeclared soy, milk, and pecans. The product was sold in multiple states and online.
Product
Pumpkin Pie with Pecans Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
Category
Food
Distribution
10 states
CriticalFDA (Food)·F-1660-2014·2014-03-19
Pecan Shed Recalls Sucrose Free Chocolate Plain Fudge for Undeclared Allergens
Pecan Shed is recalling Sucrose Free Chocolate Plain Fudge due to the presence of undeclared soy and milk allergens.
Product
Sucrose Free Chocolate Plain Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
Category
Food
Distribution
10 states