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.

1101–1125 of 7451

CriticalFDA (Devices)·Z-0886-2023·2023-01-25
Cardiosave IABP may shut down unexpectedly due to blood contamination
The Cardiosave Rescue Intra-Aortic Balloon Pump may shut down unexpectedly if blood enters the device through a compromised balloon catheter. Approximately 46 units have been distributed worldwide.
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0296-2023·2023-01-25
Dough Ball Products Recalled for Undeclared Milk Allergen
Sysco Merchandising and Supply is recalling Greco and Sons Dough Room dough ball products because they contain undeclared milk allergen, which poses a serious risk to milk-allergic consumers.
Product
Greco and Sons Dough Room Product No. 9009 Teresa's 9 oz.; Greco and Sons Dough Room Product No. 9012 Teresa's 12 oz.; Greco and Sons Dough Room Product No. 9020 Teresa's 22 oz.; Greco and Sons Dough Room Product No. 9046 Teresa's 48 oz.
Category
Food
Distribution
6 states
CriticalCPSC·23088·2023-01-09
Fisher-Price Recalls 4.7 Million Rock 'n Play Sleepers Due to Infant Deaths
Fisher-Price is recalling approximately 4.7 million Rock 'n Play Sleepers after at least 8 deaths were reported following the initial April 2019 recall announcement. Infants have died after rolling from their back to their stomach or side while unrestrained.
Product
All models of Rock 'n Play Sleepers
Category
Consumer Product
Distribution
Distributed nationwide
CriticalCPSC·23089·2023-01-09
Kids2 Rocking Sleepers Recalled After 15 Infant Deaths
Kids2 is recalling approximately 694,000 Rocking Sleepers after 15 infant fatalities were reported. Infants died after rolling from their back to their stomach or side while unrestrained.
Product
All models of Kids2 Rocking Sleepers
Category
Consumer Product
Distribution
Distributed nationwide
CriticalCPSC·23078·2022-12-22
Target Recalls Pillowfort Weighted Blankets Due to Asphyxiation Risk
Target is recalling about 204,000 Pillowfort Weighted Blankets because children can become entrapped inside the blanket cover, creating a risk of asphyxiation. Two children have died from this hazard.
Product
Pillowfort™ Weighted Blankets
Category
Consumer Product
Distribution
Distributed nationwide
CriticalUSDA FSIS·045-2022·2022-12-22
Morasch Meats Recalls Raw Frozen Diced Beef Due to E. Coli O157:H7
Morasch Meats is recalling approximately 3,930 pounds of raw frozen diced beef products produced on August 24, 2022, due to possible E. coli O157:H7 contamination.
Product
Morasch Meats, Inc — Morasch Meats Inc. Recalls Raw Frozen Diced Beef Products Due to Possible E. Coli O157:H7 Contamination
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0438-2023·2022-12-21
Arrow AC3 Optimus IABP recalled for shortened battery run-times
Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP) devices are recalled worldwide due to a potential issue with shortened battery run-times. All lot and serial numbers of model IAP-0700 are affected.
Product
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0330-2023·2022-12-14
Sensititre Medical Device Recall: False Antibiotic Susceptibility Test Results
Remel Inc. is recalling Sensititre HPB1 diagnostic plates that may produce false susceptible results for specific bacteria when tested with seven antibiotics. This could lead to inaccurate susceptibility information affecting clinical treatment decisions.
Product
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0169-2023·2022-11-30
Tiramisu Twist Cookies recalled for undeclared tree nuts
DAISO CALIFORNIA WAREHOUSE is recalling Tiramisu Twist Cookie 3.4 oz. packages due to undeclared tree nuts. Consumers with tree nut allergies face allergic reaction risk if they consume this product unknowingly.
Product
Tiramisu Twist Cookie 3.4 oz. packaged in a gold bag with a large image of two cookies on the package. SKU 4562138450820 3.4 oz. packages, 12 units per case Product of Malaysia
Category
Food
Distribution
8 states
CriticalFDA (Food)·F-0176-2023·2022-11-30
Everything But The Sushi & Dumplings sauce recalled for undeclared soy
Seed Ranch Flavor Co. is recalling Everything But The Sushi & Dumplings sauce due to undeclared soy allergen. Approximately 11,449 bottles were distributed nationwide and internationally.
Product
Everything But The Sushi & Dumplings, 5 fl. oz. (148 mL) glass bottle, UPC 8-60008-58851-7, Made for Seed Ranch Flavor Co., LLC Boulder, CO 80302. Ambient storage - minimum 35 degrees, maximum 85 degrees.
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0174-2023·2022-11-30
Umami Everyday Sauce recalled for undeclared soy allergen
Umami Everyday Sauce is being recalled due to undeclared soy allergen. This poses a risk to consumers with soy allergies and sensitivities.
Product
Umami Everyday Sauce, 5 fl. oz. (148 mL) glass bottle, UPC 8-67732-00032-2, Made for Seed Ranch Flavor Co., LLC, Boulder, CO 80302 Ambient storage - minimum 35 degrees, maximum 85 degrees.
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0066-2023·2022-11-23
Hand Sanitizer Recalled for Methanol Contamination — FDA Class I
Adam's Polishes ALCOHOL BASED HAND SANITIZER (multiple sizes) is recalled nationwide because FDA analysis found methanol contamination. This Class I recall poses a serious chemical health risk.
Product
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl.…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0058-2023·2022-11-16
Octreotide Acetate Injection Recalled for Glass Particle Contamination
Viatris Inc is recalling Octreotide Acetate Injection due to glass particles found in syringes. Approximately 22,400 syringes of lot #AJ21002 (expiration 03/2024) were distributed nationwide.
Product
OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0116-2023·2022-11-09
Multiple brands of triple creme brie cheese recalled for Listeria contamination
Old Europe Cheese, Inc. is recalling multiple brands of triple creme brie cheese due to potential contamination with Listeria monocytogenes. The recall affects products distributed across the United States and Mexico.
Product
FREDERICKS 8 oz Brie - triple cr¿me, rounds UPC 708820301214 FRESH THYME 8 oz Brie - triple cr¿me, rounds UPC 841330111987 HEINEN 8 oz Brie - triple cr¿me, rounds UPC 020601418028 JOAN OF ARC 6.5 lb Joan of Arc Triple Creme Wheel no UPC JOAN OF ARC 8 oz Joan of Arc Triple…
Category
Food
Distribution
25 states
CriticalFDA (Devices)·Z-0153-2023·2022-11-09
CritiCool Thermoregulation Device Recalled Due to Pump Failure
The CritiCool thermoregulation device may experience premature pump failure leading to a HALT 4 error from which the device cannot recover, potentially delaying treatment. One death has been reported.
Product
CritiCool, thermoregulation device
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0108-2023·2022-11-09
Brie Cheese Products Recalled Due to Potential Listeria Contamination
Old Europe Cheese, Inc. is recalling multiple brands of herb-flavored Brie cheese due to potential contamination with Listeria monocytogenes. Affected products have best-by dates ranging from September 28 to December 14, 2022.
Product
LA BONNE VIE 7 oz Brie - dbl cr¿me w/Herbs, wedges, foil wrapped UPC 820581678661 JOAN OF ARC 2.2 lb Joan of Arc Herb and Garlic Wheel no UPC MARKET 32 8 oz Brie-dbl cr¿me w/Herbs, wedges, saran wrapped UPC 41735052889 PRIMO TAGLIO 6.5 lb Brie - w/Herbs, whole wheel no UPC…
Category
Food
Distribution
25 states
CriticalCPSC·23027·2022-10-27
Goalsetter Wall-Mounted Basketball Goals Recall Due to Detachment Hazard
Goalsetter is recalling about 18,000 wall-mounted basketball goals because they can detach from walls and fall. One fatality and multiple injuries have been reported.
Product
Goalsetter wall-mounted basketball goals
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0023-2023·2022-10-12
Small Ranch Tray with Dip Recalled Due to Listeria Contamination
Renaissance Food Group is recalling its Small Ranch Tray with Dip due to positive test results for Listeria monocytogenes. Products were distributed to Alabama, Georgia, and South Carolina.
Product
Small Ranch Tray with Dip, NET WT, 21.9 OZ (1 lb 5.9 OZ) 620g, Dist. By: Renaissance Food Group LLC 4322 Moreland Ave. Conley, GA 30288, UPC, 8 26766 19087 4
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-0018-2023·2022-10-12
Mexican Style Layered Bean Dip Recalled for Listeria Contamination
Renaissance Food Group is recalling Mexican Style Layered Bean Dip (1.25 lb) distributed in Alabama, Georgia, and South Carolina due to positive test results for Listeria monocytogenes.
Product
Mexican Style Layered Bean Dip, NET WT, 1.25 lb (567g), Dist. By: Renaissance Food Group LLC 4322 Moreland Ave. Conley, GA 30288, UPC, 8 26766 14810 2
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-0005-2023·2022-10-12
Candy Corn Recalled Due to Undeclared Egg Allergen
Arcade Industries candy corn sold at Shapiro Produce stores in Massachusetts and Connecticut is recalled due to undeclared egg allergen. People with egg allergies risk allergic reaction.
Product
Candy Corn packed for Shapiro Produce stores; 15 oz; clear plastic container; UPC 0 18586 00114 4; Best by date 3/8/2023
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-0027-2023·2022-10-12
Renaissance Food Group Recalls Veggie Kabobs Due to Listeria Contamination
Renaissance Food Group is recalling 3 Skewer Veggie Kabobs due to confirmed Listeria monocytogenes contamination. Products were distributed in Alabama, Georgia, and South Carolina.
Product
3 Skewer Veggie Kabobs, NET WT, 1 LB 6 OZ (623g), Dist. By: Renaissance Food Group LLC 4322 Moreland Ave. Conley, GA 30288, UPC, ? 26766 19008 ?
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-0020-2023·2022-10-12
Mushroom Stir Fry Blend recalled due to Listeria contamination
Renaissance Food Group is recalling Mushroom Stir Fry Blend after testing detected Listeria monocytogenes in the finished product. Products were distributed to Alabama, Georgia, and South Carolina.
Product
Mushroom Stir Fry Blend, NET WT, 9 OZ (255g), Dist. By: Renaissance Food Group LLC 4322 Moreland Ave. Conley, GA 30288, UPC 8 26766 19110 2
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-0015-2023·2022-10-12
Large Mild Salsa Recalled for Listeria Monocytogenes Contamination
Renaissance Food Group is recalling Large Mild Salsa (13 oz) due to positive Listeria monocytogenes test results. Products were distributed to Alabama, Georgia, and South Carolina.
Product
Large Mild Salsa, NET WT, 13 OZ (368g), Dist. By: Renaissance Food Group LLC 4322 Moreland Ave. Conley, GA 30288, UPC, 8 26766 19089 ?
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1809-2022·2022-10-05
Scottish Smoked Salmon Recalled Due to Listeria Monocytogenes Risk
St. James Smokehouse is recalling Scottish Smoked Salmon due to possible Listeria monocytogenes contamination. The recall affects 11,141 four-ounce packs distributed domestically and internationally.
Product
St. James Smokehouse, Scotch Reserve, Scottish Smoked Salmon, Net Wt 4oz (114g)
Category
Food
Distribution
0 states
CriticalFDA (Food)·F-1802-2022·2022-10-05
Keswick Creamery Recalls Bovre Cheese for Potential Listeria Contamination
Keswick Creamery is recalling Bovre cheese in multiple flavors due to potential Listeria monocytogenes contamination. The product was distributed to farm stores and farmers markets in Washington DC, Maryland, Virginia, and Pennsylvania.
Product
Bovre, multiple flavors: plain; oregano and garlic; herbes de Provence; cranberry and honey. 8oz clear deli container, expiration dates 7/25/22, 8/1/22, 8/8/22, 8/22/22
Category
Food
Distribution
5 states