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.

5076–5100 of 7439

CriticalFDA (Devices)·Z-1035-2015·2015-02-25
GE Healthcare MRI Systems Recalled for Potential Ferrous Object Removal Delay
GE Healthcare is recalling MRI systems because a disconnected MRU could delay the removal of ferrous objects, posing a life-threatening injury risk.
Product
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1210-2015·2015-02-25
Del Monte Snack Pack Apple Slices Recalled for Listeria Risk
Del Monte is recalling specific lots of Snack Pack Apple Slices with Grapes and Cheese Litehouse Caramel Dip due to potential Listeria monocytogenes contamination.
Product
Del Monte Snack Pack Apple Slices w. Grapes & Cheese Litehouse Caramel Dip 7 ounces UPC: 7-17524-77394-4
Category
Food
Distribution
1 state
CriticalFDA (Food)·F-1221-2015·2015-02-25
Happy Apples Cinnamon Crunch Caramel Apple Recalled Due to Listeria Outbreak
Lochirco Fruit & Produce Inc. is recalling Happy Apples Cinnamon Crunch Caramel Apple products linked to a Listeria monocytogenes outbreak.
Product
Happy Apples Cinnamon Crunch Caramel Apple, Net Wt. 3.5 oz., with Best By Date range - 8/25-11/23/2014, Responsible firm name on label is Happy Apple Inc., Washington, MO., and Orosi, CA.
Category
Food
Distribution
9 states
CriticalFDA (Food)·F-1217-2015·2015-02-25
FDA Recalls Caramel Apples Linked to Listeria Outbreak
Lochirco Fruit & Produce Inc. is recalling specific Happy Apple and Kroger branded caramel apples with peanuts due to a Listeria monocytogenes outbreak.
Product
Caramel Apples with Peanuts, with Best By date range - 8/25-11/23/2014, Responsible firm name on label is Happy Apple Inc., Washington, MO., and Orosi, CA., packaged in the following configurations: Happy Apples, Net Wt. 3.75 oz., Happy Apples 3 Pack, Net Wt. 9 oz., Happy
Category
Food
Distribution
9 states
CriticalFDA (Drugs)·D-0392-2015·2015-02-25
Hospira Recalls Lactated Ringer's Injection Due to Confirmed Mold Particulates
Hospira Inc. is recalling 142,644 bags of Lactated Ringer's and 5% Dextrose Injection USP due to confirmed mold particulates in the solution.
Product
LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1216-2015·2015-02-25
FDA Recalls Caramel Apples Linked to Listeria Outbreak
Lochirco Fruit & Produce Inc. is recalling Happy Apples Crunch Topping Caramel Apples because CDC epidemiologists linked a Listeria monocytogenes illness outbreak to the product.
Product
Happy Apples Crunch Topping Caramel Apples, Net Wt. 3.5 oz., with Best By date range - 8/25-11/23/2014, Responsible firm name on label is Happy Apple Inc., Washington, MO., and Orosi, CA.
Category
Food
Distribution
9 states
CriticalUSDA FSIS·034-2015·2015-02-19
Kenosha Beef International Recalls Ready-to-Eat Beef Patties for Listeria Risk
Kenosha Beef International is recalling approximately 21,427 pounds of ready-to-eat beefsteak patties due to possible Listeria monocytogenes contamination.
Product
Kenosha Beef International, Ltd. — Kenosha Beef International Recalls Beef Product Due to Possible Listeria Contamination
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-1195-2015·2015-02-18
Freeland Foods Recalls Go Raw Organic Spice Seed Mix Due to Salmonella
Freeland Foods Inc. is recalling Go Raw Organic Spice Seed Mix because the FDA found Salmonella in the product. Consumers should stop using the recalled items.
Product
Go Raw Organic Spice Seed Mix; Net Wt. 1 lb (454 g) USDA Organic UPC 8 59888 00040 Ingredients: Sprouted Organic Pumpkin Seeds, Sprouted Organic Sunflower seeds, Organic Jalapeno, Organic Cilantro, Organic Lime Juice, Organic Spices, Celtic Sea Salt, Organic Garlic Powder
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1051-2015·2015-02-18
Teleflex Recalls MAQUET SERVO Humidifiers Due to Cracked Flex Tubes
Teleflex Medical is recalling MAQUET SERVO Humidifier 163 units because cracks may occur in the corrugated flex tube, posing a risk to patients.
Product
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tu
Category
Medical Device
Distribution
4 states
CriticalFDA (Food)·F-1037-2015·2015-02-18
Whole Foods Recalls Fat Bottom Girl Cheese for Listeria Risk
Whole Foods Market is recalling Fat Bottom Girl cheese sold in California, Arizona, and Hawaii due to potential Listeria monocytogenes contamination.
Product
Cheese sold under the brand name, Fat Bottom Girl, Ingredients: Raw sheeps' milk, salt, cheese cultures Contains Milk: 071612. Sold with a Whole Foods Market scale label in clear plastic wrap. Variable weight item.
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1070-2015·2015-02-18
Rosa Maria Ground Cumin Recalled for Undeclared Peanut Protein
N.A.C. Foods is recalling Rosa Maria Ground Cumin because it may contain undeclared peanut protein. The product was distributed in New Jersey, New York, and Pennsylvania.
Product
Rosa Maria Ground Cumin, (Comino Molido), 6 oz. (173g), UPC 707425-16041-7, Packed by NAC Foods Corp., Palisades Park, NJ.
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1179-2015·2015-02-18
Numbskull LLC Recalls Mango Sorbet Due to Listeria Risk
Numbskull LLC is recalling approximately 27.5 gallons of bulk Mango Sorbet because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to ice cream shops and restaurants in Washington and Idaho.
Product
Mango Sorbet; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-1163-2015·2015-02-18
Numbskull LLC Recalls Black Raspberry Gelato Due to Listeria Risk
Numbskull LLC is recalling Black Raspberry Gelato because raw materials may be contaminated with Listeria monocytogenes. The product was sold in Washington and Idaho.
Product
Black Raspberry Gelato; 5 liter plastic trays. Product is labeled with flavor name and production code.
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-1162-2015·2015-02-18
Numbskull LLC Recalls Choc Mint Chip Gelato Due to Listeria Risk
Numbskull LLC is recalling Choc Mint Chip Gelato because raw materials may be contaminated with Listeria monocytogenes. The product was sold in Washington and Idaho.
Product
Choc Mint Chip Gelato; 5 liter plastic trays. Product is labeled with flavor name and production code.
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-1178-2015·2015-02-18
Numbskull Lemon Sorbet Recalled for Potential Listeria Contamination
Numbskull LLC is recalling approximately 64 gallons of bulk Lemon Sorbet because raw materials may be contaminated with Listeria monocytogenes.
Product
Lemon Sorbet; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-1103-2015·2015-02-18
Numbskull LLC Recalls Dirt Ice Cream Due to Listeria Risk
Numbskull LLC is recalling approximately 650 gallons of Dirt ice cream because raw materials may be contaminated with Listeria monocytogenes.
Product
Dirt ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-1033-2015·2015-02-18
Whole Foods Recalls Mixtress Bleating Heart Cheese for Listeria Risk
Whole Foods Market is recalling Mixtress Bleating Heart cheese sold in California, Arizona, and Hawaii due to potential Listeria monocytogenes contamination.
Product
Cheese sold unde the brand name, MIXTRESS BLEATING HEART NEW JERSEY COW MILK RAW SHEEPS MILK SALT CULTURES. Sold with a Whole Foods Market scale label in clear plastic wrap. Variable weight item.
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1036-2015·2015-02-18
Whole Foods Recalls Goldette Tommette Cheese for Listeria Risk
Whole Foods Market is recalling Goldette Tommette cheese in California, Arizona, and Hawaii due to potential Listeria monocytogenes contamination.
Product
Cheese sold under the brand name, Goldette Tommette Bleating Heart, Ingredients: Raw Jersey Cow Milk, Salt, Cultures Contains Milk: 032814. Sold with a Whole Foods Market scale label in clear plastic wrap. Variable weight item.
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1034-2015·2015-02-18
Whole Foods Recalls Moolicious Blue Cheese for Listeria Risk
Whole Foods Market is recalling Moolicious Blue Bleating Heart raw cow milk cheese sold in California, Arizona, and Hawaii due to potential Listeria monocytogenes contamination.
Product
Cheese sold under the brand name, MOOLICIOUS BLUE BLEATING HEART RAW COW MILK SALT CULTURES. Sold with a Whole Foods Market scale label in clear plastic wrap. Variable weight item.
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1051-2015·2015-02-18
Full Tilt Green Tea Chip Ice Cream Recalled for Listeria Risk
Full Tilt Ice Cream is recalling Green Tea Chip ice cream due to potential Listeria monocytogenes contamination from a recalled ingredient.
Product
Green Tea Chip ice cream, labeled in part, "***Full Tilt ice cream Green Tea Chip***Ingredients: Cream, milk, skim milk, sugar, green tea powder, Chocolate Chips (unsweetened chocolate, sugar, cocoa fat, soy lecithin, vanilla), corn syrup solids, carob bean gum, guar gum, soy lec
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1050-2015·2015-02-18
Full Tilt Dark Chocolate Ice Cream Recalled for Listeria Risk
Full Tilt Ice Cream is recalling Dark Chocolate ice cream due to potential Listeria monocytogenes contamination from a recalled ingredient.
Product
Dark Chocolate ice cream, labeled in part, "***Full Tilt ice cream Dark Chocolate***Ingredients: Cream, milk, skim milk powder, sugar, skim milk, bittersweet chocolate, Dutch process cocoa, vanilla, corn syrup solids, chocolate liquor, carob bean gum, guar gum, soy lecithin, carr
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1131-2015·2015-02-18
Numbskull LLC Recalls Peanut Butter Bacon Ice Cream Due to Listeria Risk
Numbskull LLC is recalling Peanut Butter Bacon ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed in Washington and Idaho.
Product
Peanut Butter Bacon ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-1133-2015·2015-02-18
Numbskull LLC Recalls Peanut Butter Fudge Ice Cream Due to Listeria Risk
Numbskull LLC is recalling approximately 12 gallons of Peanut Butter Fudge ice cream because raw materials may be contaminated with Listeria monocytogenes.
Product
Peanut Butter Fudge ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-1077-2015·2015-02-18
Numbskull LLC Recalls Banana Ice Cream Due to Listeria Risk
Numbskull LLC is recalling approximately 30 gallons of bulk banana ice cream because raw materials may be contaminated with Listeria monocytogenes.
Product
Banana ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-1140-2015·2015-02-18
Numbskull LLC Recalls S'Morchata Ice Cream Due to Listeria Risk
Numbskull LLC is recalling S'Morchata ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to scoop shops and restaurants in Washington and Idaho.
Product
S'Morchata ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
Category
Food
Distribution
2 states