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.

226–250 of 758

CriticalFDA (Food)·F-1671-2024·2024-08-14
Palmer Candy and Meijer Popcorn Products Recalled for Salmonella
Palmer & Company is recalling Palmer Candy Drizzled Caramel Corn and Meijer Drizzled Caramel Popcorn Snack Bowls due to potential Salmonella contamination. Products were distributed nationwide in the United States and Canada.
Product
1. Palmer Candy Drizzled Caramel Corn, Item 19271, Net Wt. 16/5oz tubs, UPC 77343 19271 2. Meijer Drizzled Caramel Popcorn Snack Bowl, Net Wt. 12oz, UPC 60236 18830, 8/12oz case
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1677-2024·2024-08-14
Wiers Farm Poblano Peppers recalled for Listeria contamination
Wiers Farm Inc is recalling Poblano peppers in 16oz bags due to Listeria monocytogenes contamination. The product was distributed across multiple states.
Product
Wiers Farm - Poblano packaged in 16oz plastic bag - 10 bags in a case
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-1651-2024·2024-08-14
Shelled walnuts recalled due to Listeria contamination
Stutz Packing Company is recalling 2,538 cases of shelled walnuts due to Listeria contamination. The affected product was distributed in Texas and Arizona.
Product
Shelled Walnuts 1lb package in plastic flexible packaging. 24 packages per case
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-1683-2024·2024-08-14
Wiers Farm Organic Yellow Squash Recalled for Listeria Contamination
Wiers Farm Inc is recalling organic yellow squash in 2-count trays due to Listeria monocytogenes contamination. The recall affects 54 cases distributed across 17 states.
Product
Wiers Farm - Organic Yellow Squash packaged into 2 count trays - cases dependent on customer
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-1678-2024·2024-08-14
Cubanelle Peppers from Wiers Farm Recalled for Listeria Contamination
Wiers Farm is recalling specific lots of cubanelle peppers due to potential Listeria monocytogenes contamination. The affected products were distributed across 18 states.
Product
Wiers Farm - Cubanelle packaged in 16oz plastic bag - 10 bags in a case
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-1645-2024·2024-08-14
Bazzini Raw Almond Butter Recalled for Undeclared Peanuts
Bazzini LLC is recalling 684 jars of Bazzini Raw Almond Butter (Lot code 2E136) due to undeclared peanuts, posing a serious risk to peanut-allergic consumers. The affected product was distributed to retailers in New York.
Product
Bazzini Raw Almond Butter Net Wt. 16 oz (454g) UPC Code 7506284009. Packaged in clear plastic jars with plastic white lids. 12 jars per case
Category
Food
Distribution
1 state
CriticalFDA (Devices)·Z-2446-2024·2024-08-14
Puritan Bennett 500 Series Ventilators recalled due to volatile organic compound release
Covidien recalls 34,642 Puritan Bennett 500 Series Ventilators due to release of volatile organic compound (2-propanol, 1,3-dichloro) from gas pathway components during prolonged use beyond 10 years.
Product
Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, PURITAN BENNETT 560 VENTILATOR APAC/4096600-03, Puritan Bennett 560 Ventilat
Category
Medical Device
Distribution
34 states
CriticalFDA (Devices)·Z-2442-2024·2024-08-14
Medline Medical Procedure Kits Recalled Due to Defective Plastic Syringes
Medline is recalling over 1.6 million medical procedure kits nationwide and internationally due to plastic syringe defects. The affected kits contain syringes with leaks, breakage, and quality issues that may pose risks to patient health.
Product
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1695-2024·2024-08-14
Wiers Farm Tomatillos Recalled Due to Listeria Monocytogenes Contamination
Wiers Farm is recalling 1,467 cases of tomatillos due to Listeria monocytogenes contamination. Affected lot numbers 240705-240712 were distributed across 17 states.
Product
Wiers Farm - Tomatillos packaged in 1lb cartons - case size dependent on customer
Category
Food
Distribution
18 states
CriticalFDA (Food)·F-1535-2024·2024-08-07
Diamond Shruumz Gummies Recalled for Toxic Levels of Muscimol
Diamond Shruumz Gummies (Micro Dose Sour Peach Apple) manufactured by Prophet Premium Blends, LLC, are being recalled by the FDA due to toxic levels of muscimol. The Class I recall affects approximately 248,007 products distributed nationwide.
Product
Diamond Shruumz Gummies - Micro Dose Sour Peach Apple UPC 755003861386
Category
Food
Distribution
51 states
CriticalFDA (Food)·F-1540-2024·2024-08-07
Diamond Shruumz Gummies recalled for toxic muscimol levels
Diamond Shruumz Gummies Mega/Extreme Dose Peach Paradise contain toxic levels of muscimol. The FDA is recalling all 248,007 units distributed nationwide.
Product
Diamond Shruumz Gummies - Mega/Extreme Dose Peach Paradise UPC 810133320384
Category
Food
Distribution
51 states
CriticalFDA (Drugs)·D-0620-2024·2024-08-07
Dietary Supplement Recalled for Undeclared Diclofenac and Omeprazole
SoloVital's Umary Hyaluronic Acid supplement was recalled because FDA testing found it contains undeclared Diclofenac and Omeprazole. The product, marketed without approved NDA/ANDA, affected 1,331 bottles distributed nationwide.
Product
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2319-2024·2024-07-24
Abiomed Impella CP with SmartAssist heart pump units recalled for failed inspection
Abiomed is recalling 9 Impella CP with SmartAssist heart pump units that failed inspection and were inadvertently released. The devices were distributed in Florida, Massachusetts, Ohio, and Texas.
Product
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Category
Medical Device
Distribution
4 states
CriticalFDA (Food)·F-1483-2024·2024-07-24
Deluxe Roasted Salted Mixed Nuts recalled for undeclared peanut allergen
DSD Merchandisers recalls Deluxe Roasted Salted Mixed Nuts (Item 99651) for undeclared peanut allergen, with distribution in six western states and a sell-by date of October 9, 2024. Consumers with peanut allergies should not consume this product.
Product
Deluxe Roasted Salted Mixed Nuts ITEM NUMBER 99651 UPC: 6-51433-99651-6 SELL BY: 10/09/2024
Category
Food
Distribution
6 states
CriticalFDA (Food)·F-1464-2024·2024-07-17
Crecelac Infant Powdered Formula Recalled Due to Cronobacter
Dairy Manufacturers' Crecelac Infant formula (5,376 cans distributed in Texas) is recalled due to Cronobacter spp. detected during FDA testing. Products lack required premarket evaluation for food safety and nutritional standards.
Product
Crecelac Infant 0-12 powdered infant formula with iron 12.4 oz cans
Category
Food
Distribution
0 states
CriticalFDA (Devices)·Z-2252-2024·2024-07-17
Medical Device Recall: Bausch+Lomb Intravitreal Injection Kit Unvalidated Sterilization
Synergetics Inc is recalling Bausch+Lomb I-PACK Intravitreal Injection Kits because sterilization certificates could not be validated by the supplier. The FDA classified this as Class I.
Product
BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1424-2024·2024-07-03
Pop a Nosh Mixed Munch snacks recalled for undeclared wheat
AMB FOODS INC is recalling Pop a Nosh Mixed Munch snacks due to undeclared wheat allergen. Approximately 2,100 units distributed in New York contain wheat, which is not labeled on the product.
Product
Pop a Nosh Mixed Munch; Regular Flavor; 8oz plastic bag; Potato Chips, Popcorn, Pretzels; UPC 914669941
Category
Food
Distribution
0 states
CriticalFDA (Devices)·Z-2140-2024·2024-07-03
Life2000 Ventilator systems recalled due to battery charging failure risk
The Life2000 Ventilator may fail to charge or experience intermittent charging behavior due to damage to the battery charger dongle. This FDA Class I recall affects approximately 2,510 units distributed nationwide.
Product
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
Category
Medical Device
Distribution
Distributed nationwide
CriticalCPSC·24744·2024-06-27
Dania Furniture Recalls Hayden Bookcase Due to Tip-Over Hazard
Dania Furniture is recalling about 940 Hayden Bookcases sold from November 2017 through February 2024 because the bookcase can tip over and cause entrapment injuries if not anchored to the wall. A 4-year-old child died from a tip-over incident in August 2023.
Product
Hayden Bookcase
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1388-2024·2024-06-26
New Seasons Market Strawberry Rhubarb Bakewell Tart Recalled for Undeclared Almond
New Seasons Market is recalling its Strawberry Rhubarb Bakewell Tart due to undeclared almond. The 261 units distributed in Oregon and Washington pose an allergen risk to consumers with almond allergies.
Product
New Seasons Market Strawberry Rhubarb Bakewell Tart, packaged in a plastic clamshell with scale label. Contains Milk, Wheat, Eggs.
Category
Food
Distribution
0 states
CriticalFDA (Food)·F-1353-2024·2024-06-19
Frozen Scallop Ingredient Recalled Due to Potential Salmonella Contamination
Kerry, Inc is recalling Scallop Pot Seas frozen scallop ingredient due to potential Salmonella contamination. The product was distributed to commercial customers in multiple U.S. states and Canada.
Product
Scallop Pot Seas 703161, 860 kg. SAP Code: 30589206. Kerry Ingredients, 3400 Millington Road, Beloit, WI 53511
Category
Food
Distribution
8 states
CriticalFDA (Food)·F-1345-2024·2024-06-19
Baraka Brand Ground Black Pepper Recalled for Potential Salmonella Contamination
U.B.C. Food Distributors is recalling Baraka brand ground black pepper due to potential Salmonella contamination. The product is packaged in 7oz retail containers with UPC 8 22514 26626 6.
Product
Baraka brand ground black pepper packaged in 7oz retail containers with UPC 8 22514 26626 6; 10 units per case
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1370-2024·2024-06-19
Cultured Dairy Product Recalled for Possible Salmonella Contamination
Grande Grande Primo Y45 cultured dairy product is being recalled due to possible Salmonella contamination. The product was distributed across multiple U.S. states and internationally to Canada, Ecuador, and Japan.
Product
Grande Grande Primo Y45 Cultured Dairy Product. Product Code: 32400. Grade A. Pasteurized. Net Wt 50 lbs. Ingredients: Whey Protein Concentrate, Skim Milk, Yogurt Cultures (L. bulgaricus, S. thermophilus). Heat Treated After Culturing. Contains Milk. Grande Custom Ingr
Category
Food
Distribution
24 states
CriticalFDA (Food)·F-1366-2024·2024-06-19
Grande Bravo 600 Whey Protein Recalled for Possible Salmonella Contamination
Grande Cheese Company is recalling Grande Bravo 600 Functional Whey Protein for possible Salmonella contamination. The affected product was distributed to 24 US states and to Canada, Ecuador, and Japan.
Product
Grande Bravo 600 Functional Whey Protein SKU 32106. 34% Protein. Grade A. Pasteurized. Net Wt 50 lbs. Ingredients: Whey Protein Concentrate Contains Milk. Grande Custom Ingredients Group, 250 Camelot Drive, Fond du Lac, WI
Category
Food
Distribution
24 states
CriticalFDA (Food)·F-1352-2024·2024-06-19
Newly Weds Foods Breader Recalled for Potential Salmonella Contamination
Newly Weds Foods is recalling its Breader X7 in 50-pound bags due to potential Salmonella contamination in an ingredient. The contamination poses a serious health risk.
Product
Newly Weds Foods, LLC A51638 Breader X7 50lb bag
Category
Food
Distribution
3 states