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.

376–400 of 758

CriticalFDA (Food)·F-0288-2024·2023-10-25
Mooncakes Recalled Due to Undeclared Egg Allergen
Sheng Kee Bakery mooncakes recalled for undeclared egg allergen across CA, IL, TX, GA, WA, and NJ. Consumers with egg allergies should not consume.
Product
Small 12 -3 Flavor Assorted Mooncake Gift Box Small 12- 4 Flavor Assorted Mooncake Gift Box Small 12- 6 Flavor Assorted Mooncake Tin Gift Box Small 6- 3 Flavor Assorted Mooncake Gift Box Small 9- 3 Flavor Assorted Mooncake Gift Box Assorted Large 4 Mooncake Gift Box
Category
Food
Distribution
6 states
CriticalCPSC·24011·2023-10-19
Fortress Safe Biometric Gun Safes: Unauthorized Access and Risk of Death
Xpedition LLC is recalling approximately 61,000 biometric gun safes because the biometric locks can be opened by unauthorized users, posing serious injury and death risks. One death has been reported in a recent lawsuit.
Product
Biometric Gun Safes
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0287-2024·2023-10-18
Quaker Pancakes with Whole Grain Oats Recalled for Undeclared Soy Allergen
Comercializadora Pepsico Mexico recalls Quaker Pancakes with Whole Grain Oats due to undeclared soy allergen. The product contains soy not listed on the label, creating a health risk for consumers with soy allergies.
Product
QUAKER PANCAKES WITH WHOLE GRAIN OATS, NET WT 15.97OZ (1LB)
Category
Food
Distribution
0 states
CriticalFDA (Devices)·Z-0028-2024·2023-10-18
FDA Recalls Fresenius 2008T Hemodialysis Systems Due to PCBA Leaching
Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.
Product
2008T Hemodialysis SYS, with CDX
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0011-2024·2023-10-18
Ginger Snap Milk Chocolate recalled for undeclared peanut allergen
Dick Taylor Inc is recalling Ginger Snap Milk Chocolate due to undeclared peanut allergen. People with peanut allergies may experience serious allergic reaction if they consume this product.
Product
Ginger Snap Milk Chocolate, 2 oz wrapped
Category
Food
Distribution
0 states
CriticalFDA (Drugs)·D-0037-2024·2023-10-11
FDA Recalls Dr. Berne's MSM Drops Due to Non-Sterility Concerns
Dr. Berne's MSM DROPS 5% Solution was recalled by the FDA for non-sterility issues. Lot 6786, with expiration date March 31, 2025, is distributed nationwide and internationally.
Product
Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001111.
Category
Drug
Distribution
Distributed nationwide
CriticalCPSC·24002·2023-10-05
Cocco Candy Rolling Candy Recalled Due to Choking Hazard
KGR Distribution Corp. recalls Cocco Candy Rolling Candy in multiple flavors because the candy's rolling ball can dislodge and pose a choking hazard. One death has been reported.
Product
Cocco Candy Rolling Candy
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1677-2023·2023-10-04
Cup Cake Party products recalled due to Listeria monocytogenes contamination
Ice Cream House is recalling Cup Cake Party products due to potential Listeria monocytogenes contamination. Products were distributed in Ohio, New Jersey, and New York.
Product
Cup Cake Party; dairy / parve; 6 PACK / SINGLE; UPC: 0-91404-15287-7
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1672-2023·2023-10-04
Trimocha Vanilla ice cream recalled for potential Listeria contamination
Ice Cream House is recalling Trimocha Vanilla ice cream due to potential Listeria monocytogenes contamination. The affected product was distributed in Ohio, New Jersey, and New York.
Product
Trimocha Vanilla; dairy / parve; 6 PACK / SINGLE; UPC: 0-91404-15229-7
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1655-2023·2023-10-04
Sorbet Swirl Ice Cream Recalled Due to Listeria Contamination Risk
ICE CREAM HOUSE is recalling Sorbet Swirl ice cream due to potential Listeria monocytogenes contamination. Affected products were distributed in Ohio, New Jersey, and New York.
Product
Sorbet Swirl; parve; 6 PACK / SINGLE; UPC: 0-91404-15400-0
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1601-2023·2023-10-04
Hamburger Buns Recalled for Undeclared Milk Allergen in Michigan
Knickerbocker Homestyle hamburger buns are recalled due to undeclared milk, posing risk to consumers with dairy allergies. The voluntary recall affects 668 retail units distributed to stores and restaurants in southeastern Michigan.
Product
Knickerbocker Homestyle hamburger buns, 16oz, 8 count in clear plastic bag, UPC 6 11625 10020 6
Category
Food
Distribution
1 state
CriticalFDA (Food)·F-1689-2023·2023-10-04
Dessert on Wheels Recalled Due to Listeria Contamination
Ice Cream House is recalling Dessert on Wheels products sold in Ohio, New Jersey, and New York because they may be contaminated with Listeria monocytogenes. Consumers should not consume the affected products.
Product
Dessert on Wheels; dairy / parve; 4 PACK / SINGLE; UPC: 0-91404-15339-3
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1635-2023·2023-10-04
Round cake recalled for potential Listeria monocytogenes contamination
Ice Cream House is recalling round cakes (UPC 0-91404-15181-8) distributed in Ohio, New Jersey, and New York due to potential Listeria monocytogenes contamination. Consumers should not consume the product.
Product
{P} 6' Round Cake; dairy / parve; 1 PACK; UPC: 0-91404-15181-8
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1644-2023·2023-10-04
Ice Cream House Strawberry Shortcake Roll Recalled for Listeria Contamination
Ice Cream House Strawberry Shortcake Roll products may contain Listeria monocytogenes. Consumers in Ohio, New Jersey, and New York should not consume affected products.
Product
{P} Strawberry Shortcake Roll; parve; 1 PACK / SINGLE; UPC: 0-91404-15298-0
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1631-2023·2023-10-04
Heart Cakes from Ice Cream House Recalled for Listeria Contamination
Heart cakes from Ice Cream House are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Ohio, New Jersey, and New York.
Product
10' Heart Cake; dairy / parve; 1 PACK; UPC: 0-91404-15171-9 and 8' Heart Cake; dairy / parve; 1 PACK; UPC: 0-91404-15309-6 and 6' Heart Cake; dairy / parve; 1 PACK; UPC: 0-91404-15172-6 and Mini Heart Cake; dairy / parve; 1 PACK; UPC: 0-91404-15173-3
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1617-2023·2023-10-04
Ice cream product recalled for undeclared egg allergen
Weis Quality Brownie Moose Tracks Ice Cream (48oz) is recalled due to undeclared egg. The product was distributed to retail locations in Delaware, Maryland, New Jersey, New York, Pennsylvania, Virginia, and West Virginia.
Product
Weis Quality Brownie Moose Tracks Ice Cream (48oz)UPC of 041497-01194 Packaged in a scround container. 6 units per case.
Category
Food
Distribution
7 states
CriticalFDA (Food)·F-1626-2023·2023-10-04
FDA Recalls Ice Cream Pie for Listeria Monocytogenes Contamination
ICE CREAM HOUSE is recalling 9-inch ice cream pies distributed in Ohio, New Jersey, and New York due to potential Listeria monocytogenes contamination. Consumers should not consume the product.
Product
9'' Ice Cream Pie Vanilla / Chocolate; dairy / parve; 1 PACK; UPC: 0-91404-15428-4
Category
Food
Distribution
3 states
CriticalCPSC·23299·2023-09-29
Future Motion Onewheel Electric Skateboards Recalled for Crash Hazard
Future Motion is recalling approximately 300,000 Onewheel self-balancing electric skateboards because they can stop balancing and cause the rider to crash. Four deaths and dozens of injuries including head trauma, fractures, and paralysis have been reported.
Product
Onewheel Electric Skateboards (all models)
Category
Consumer Product
Distribution
Distributed nationwide
CriticalCPSC·23290·2023-09-21
HONEY JOY Infant Swings Recalled for Suffocation Hazard
HONEY JOY infant swings are recalled due to a suffocation hazard. The product violates federal safety standards because it has an incline angle greater than 10 degrees and was marketed for infant sleep, and infant fatalities have been reported in similar inclined sleepers.
Product
HONEY JOY Infant Swings
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2509-2023·2023-09-20
Abbott Proclaim DRG Implantable Pulse Generators cannot exit MRI mode
Abbott Medical is recalling approximately 17,394 Proclaim DRG Implantable Pulse Generators worldwide due to reports that patients cannot exit MRI mode on affected devices. This malfunction may prevent normal device operation when mode-switching is needed.
Product
Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery with
Category
Medical Device
Distribution
Distributed nationwide
CriticalCPSC·23286·2023-09-14
Chuckle & Roar Ultimate Water Beads Activity Kits Recalled for Ingestion and Choking Hazards
Buffalo Games and Target are recalling Chuckle & Roar Ultimate Water Beads Activity Kits because ingested water beads expand and can cause choking and intestinal obstruction in children. One infant death and one serious injury requiring surgery have been reported.
Product
Chuckle & Roar Ultimate Water Beads Activity Kits
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1454-2023·2023-08-23
Black melon seeds recalled for undeclared soy and wheat allergens
Richin Trading Inc is recalling Tim Heung Yuen Black Melon Seed due to undeclared soy and wheat allergens. The product was distributed across 12 U.S. states. Consumers with these allergies should not consume the product.
Product
Tim Heung Yuen Black Melon Seed 6 oz., 12 oz. Ingredients: Melon Seeds, Salt, Sugar & Anise Seed Distributed By Richin Trading Inc. TEL (626) 308-3212 Allergen Warning: This repacked product was processed on shared equipments that also processed peanuts, soybean, and nuts. UPC 7
Category
Food
Distribution
12 states
CriticalFDA (Devices)·Z-2383-2023·2023-08-23
FDA Recalls Dialysis Catheters for Center Lumen Obstruction Risk
Covidien is recalling MAHURKAR dialysis catheters because the center lumen may be blocked by excess silicone lubricant. This could delay treatment and cause blood clots, hemolysis, or embolism.
Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
Category
Medical Device
Distribution
Distributed nationwide
CriticalCPSC·23263·2023-08-17
Zipadee Kids Convertible House Bed Frames Recalled for Entrapment and Strangulation Risk
Zipadee Kids Convertible House Bed Frames and Montessori Floor Beds are being recalled due to spindle spacing that can trap a child's torso while preventing their head from passing through, creating a strangulation hazard. At least two children have become entrapped.
Product
Zipadee Kids Convertible House Bed Frames and Montessori Floor Beds
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1399-2023·2023-08-16
Burger buns recalled for undisclosed wheat and sesame allergens
Saffron Inc. is recalling burger buns because labels fail to disclose wheat and sesame allergens present in the product. The affected products were distributed to one distributor in South Carolina.
Product
BURGER BUN WITH SEEDS 3507402 Flour, water, potato flour, eggs, sugar, shortening, milk powder, salt, yeast, S200 UPC 682863 049657
Category
Food
Distribution
0 states