Severity 5 of 5

Critical recalls

Highest-severity recall. The hazard can cause serious injury or death. 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.

1076–1100 of 7451

CriticalFDA (Food)·F-0285-2024·2023-03-22
Fresh Creative Cuisine Yogurt Recalled for Potential Listeria Contamination
Fresh Creative Cuisine Black Label vanilla yogurt cups are recalled due to potential Listeria monocytogenes contamination. The 9 oz. single-serving products sold between January 24-30, 2023 were distributed across 11 states.
Product
Fresh Creative Cuisine Black Label, Vanilla Low Fat Yogurt, Mixed Berries & Granola, Net Wt. 9 Oz. Single Serving, Keep refrigerated
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0448-2023·2023-03-22
Quick & Fresh Egg Muffin Recalled Due to Potential Listeria Contamination
Fresh Ideation Food Group is recalling Quick & Fresh egg muffins due to potential Listeria monocytogenes contamination. The affected products were distributed across 11 states from January 24–30, 2023.
Product
Quick & Fresh, Colby, Cheddar & Egg Muffin, Net . Wt. 5.5 Oz. Single Serving, Mylar Wrap, Keep refrigerated
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0106-2024·2023-03-22
Fresh Creative Cuisine vegetables and hummus recalled for Listeria
Fresh Creative Cuisine is recalling Black Label Fresh Cut Vegetables & Hummus sold in late January 2023 due to potential Listeria monocytogenes contamination.
Product
Fresh Creative Cuisine Black Label, Fresh Cut Vegetables & Hummus, Net Wt. 6.4 Oz. Single Serving, Keep refrigerated
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0540-2023·2023-03-22
Fresh Creative Cuisine Fresh Grapes recalled for potential Listeria contamination
Fresh Creative Cuisine Fresh Grapes sold January 24-30, 2023 across eleven states are being recalled due to potential Listeria monocytogenes contamination. No illnesses have been reported.
Product
Fresh Creative Cuisine, Fresh Grapes, Net . Wt. 7 Oz. Single Serving, Keep refrigerated
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0482-2023·2023-03-22
Naval Academy1845 Coffee, Gourmet Cheese and Fruit Plate Recalled for Listeria
Naval Academy1845 Coffee, Gourmet Cheese and Fruit Plate products are being recalled due to potential Listeria monocytogenes contamination. The affected products were distributed across multiple states.
Product
Naval Academy1845 Coffee, Gourmet Cheese & Fruit Plate, Net Wt. 6 Oz. Single Serving, Keep refrigerated
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0094-2024·2023-03-22
Cheese and Fruit Plate Recalled for Potential Listeria Contamination
Fresh Creative Cuisine cheese and fruit plates are being recalled due to potential Listeria monocytogenes contamination. The recalled products were sold between January 24 and 30, 2023 across 11 states.
Product
Fresh Creative Cuisine White Label, Fall Cheese & Fruit Plate, Net Wt. 6 Oz. Single Serving, Keep refrigerated
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0130-2024·2023-03-22
Fresh Creative Cuisine Ham & American Hoagie Recalled for Listeria Risk
Fresh Creative Cuisine Ham & American Hoagie sandwiches are recalled for potential Listeria monocytogenes contamination. Affected 6.5 oz products distributed across multiple states from January 24-30, 2023.
Product
Fresh Creative Cuisine White Label, Ham & American Hoagie, Net Wt. 6.5 Oz. Single Serving, Keep refrigerated
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0526-2023·2023-03-22
Caprese Baguette Recalled for Listeria Monocytogenes Contamination
Fresh Creative Cuisine Caprese Baguette products distributed January 24-30, 2023, are recalled for potential Listeria monocytogenes contamination across multiple states and Washington D.C.
Product
Fresh Creative Cuisine, Caprese Baguette, Net . Wt. 8.25 Oz. Single Serving, Keep refrigerated
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0194-2024·2023-03-22
Quick & Fresh Turkey Sandwich Recalled for Potential Listeria Contamination
Fresh Ideation Food Group is recalling Quick & Fresh Peppered Turkey & Havarti sandwiches due to potential Listeria monocytogenes contamination. The affected products were distributed in January 2023 across multiple eastern states.
Product
Quick & Fresh, Peppered Turkey & Havarti on Oat Roll, Net . Wt. 8.25 Oz. Single Serving, Keep refrigerated
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0559-2023·2023-03-22
Marble Loaf from Fresh Creative Cuisine Recalled for Listeria Contamination
Fresh Creative Cuisine marble loaf products sold January 24–30, 2023 are recalled for potential Listeria monocytogenes contamination. The FDA Class I recall affects 10 units distributed across 11 states.
Product
Fresh Creative Cuisine, Marble Loaf, Net . Wt. 3.5 Oz. Single Serving, Keep refrigerated
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0511-2023·2023-03-22
Bistro To Go Turkey & Cheese Finger Sandwiches Recalled for Listeria Contamination
Fresh Creative Cuisine is recalling Bistro To Go Turkey & Cheese Finger Sandwiches due to potential Listeria monocytogenes contamination. The affected products were distributed in January 2023.
Product
Bistro To Go, Turkey & Cheese Finger Sandwiches, Net Wt. 6.5 Oz. Single Serving, Keep refrigerated
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0530-2023·2023-03-22
Cranberry Chicken Salad Brioche Recalled for Listeria Contamination Risk
Fresh Creative Cuisine is recalling Cranberry Chicken Salad Brioche products sold January 24-30, 2023 due to potential Listeria monocytogenes contamination. Affected states include MD, PA, DE, NY, DC, NJ, NC, CT, SC, VA, and MA.
Product
Fresh Creative Cuisine, Cranberry Chicken Salad Brioche, Net . Wt. 7.6 Oz. Single Serving, Keep refrigerated
Category
Food
Distribution
11 states
CriticalFDA (Drugs)·D-0455-2023·2023-03-15
Hand Sanitizer Recalled for Methanol and Acetaldehyde Contamination
Snowy Range Blue hand sanitizer is recalled due to FDA findings of methanol, acetaldehyde, and acetal above permissible limits. The product was distributed nationwide across all lot codes.
Product
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1148-2023·2023-03-15
Cardiosave Rescue intra-aortic balloon pump may shut down unexpectedly
The Cardiosave Rescue intra-aortic balloon pump may suddenly stop working due to communication failure between internal circuit boards, interrupting patient therapy and threatening hemodynamic stability.
Product
Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
CriticalCPSC·23150·2023-03-09
Calico Critters Animal Figures Recalled Due to Choking Hazard; Two Deaths Reported
Epoch Everlasting Play is recalling more than 3.2 million Calico Critters animal figures and sets sold with bottle and pacifier accessories due to choking hazard. Two fatal incidents have been reported.
Product
Calico Critters® Animal Figures and Sets sold with Bottle and Pacifier Accessories
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0371-2023·2023-03-01
Harvest Biscuits recalled for undeclared soy and peanut allergens
Harvest Biscuits 4Kinds of Nuts (94g units) are recalled because the product contains soy and peanuts that are not listed on the ingredient label. The product was distributed to Daiso stores across multiple US states and Canada.
Product
Harvest Biscuits 4Kinds of Nuts 94g units UPC:4901940041558
Category
Food
Distribution
6 states
CriticalFDA (Food)·F-0374-2023·2023-03-01
Daiso: Fly Beans Senbei cracker recall due to unlabeled peanuts
Daiso is recalling KASHIWADO Hitoritoiro Fly Beans Senbei because the product contains peanuts not listed on the label, creating a risk for consumers with peanut allergies.
Product
KASHIWADO Hitoritoiro Fly Beans Senbei UPC:4904036008213
Category
Food
Distribution
6 states
CriticalFDA (Food)·F-0402-2023·2023-03-01
Ready-to-Eat Soup Recalled: Rao's Contains Undeclared Egg Allergen
Rao's Made for Home Slow Simmered Soup labeled as Chicken & Gnocchi is being recalled because it actually contains vegetable minestrone with an undeclared egg allergen. The recall affects 13,751 cases distributed across multiple states.
Product
Rao's Made for Home Slow Simmered Soup, labeled as Chicken & Gnocchi, Soup in 16-ounce glass jars, 6 jars per case. Shelf stable, refrigerate after opening.
Category
Food
Distribution
12 states
CriticalFDA (Food)·F-0370-2023·2023-03-01
Harvest Sesame Recalled for Undeclared Soy and Sesame Allergens
Daiso is recalling Harvest Sesame 94g units due to undeclared soy and sesame allergens on the label. The recall affects 317,751 units distributed across Daiso retail locations in six U.S. states and Canada.
Product
Harvest Sesame 94g units UPC:4901940041312
Category
Food
Distribution
6 states
CriticalCPSC·23136·2023-02-23
LumaRail Bed Assist Rails recalled for entrapment and asphyxia hazard
Platinum Health is recalling about 53,000 LumaRail bed assist rails because users can become entrapped between the rail and mattress, risking death by asphyxiation. One death has been reported.
Product
LumaRail Bed Assist Rails
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1056-2023·2023-02-15
GE Nuclear Medicine Imaging Systems detector fall hazard
GE Nuclear Medicine 600/800 series imaging systems may have faulty detectors that could fall, causing serious injury. Mitigation measures may not be properly implemented on 34 units distributed worldwide.
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0246-2023·2023-02-08
First Aid Kit with Burn Cream Recalled for Bacterial Contamination
GFA Production is recalling Adventure First Aid 1.0 kits containing Easy Care After Burn Cream due to confirmed bacterial contamination found in FDA testing. The affected product was distributed nationwide and in Canada.
Product
Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0213
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0250-2023·2023-02-08
Easy Care First Aid Kit Recalled for Bacterial Contamination
GFA Production is recalling Easy Care First Aid Kits distributed nationwide and in Canada due to bacterial contamination of included After Burn Cream packets. The FDA confirmed the presence of Bacillus lichenformis and Bacillus sonorensis.
Product
Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2150
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0244-2023·2023-02-08
Easy Care first aid burn cream recalled for microbial contamination
Easy Care first aid burn cream distributed nationwide and in Canada is recalled due to FDA-detected contamination with Bacillus lichenformis and Bacillus sonorensis. The product should not be used.
Product
Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9 g (0.03 oz) packets packaged in boxes of 10, Treatment for Burns, Made in China for Adventure Ready Brands, 944 Industrial Park Rd., Littleton, NH 03561, NDC 90107-0210, Product #…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0184-2023·2023-02-01
Vancomycin Hydrochloride Injection Recalled for Glass Particulate Matter
Pfizer recalls approximately 89,700 vials of Vancomycin Hydrochloride for Injection due to glass particulate matter contamination. The recalled product (Lot 33045BA) was distributed across the USA and Puerto Rico.
Product
VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide