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.

151–175 of 758

CriticalFDA (Food)·F-0916-2025·2025-06-11
Fresh Take Tuna Salad Sandwich Recalled for Listeria Monocytogenes (FDA Class I)
Fresh & Ready Foods LLC recalls Fresh Take Tuna Salad Sandwich due to Listeria monocytogenes detected in the manufacturing facility. Approximately 139,863 units with best-by dates May 9-19, 2025, were distributed to the Southwest and military facilities.
Product
Fresh Take Crave Away Tuna Salad on Wheat Sandwich; 5oz PLASTIC CONTAINER; Best By: 05/09/2025 - 05/19/2025 UPC# 8 06795 58575 2
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0899-2025·2025-06-11
Fresh Take Beef Cheesesteak Sub Sandwich Recalled for Listeria Contamination
Fresh Take Crave Away Beef Cheesesteak Sub Sandwich (6 oz containers, Best By May 9–19, 2025) is recalled due to Listeria monocytogenes detected on food contact surfaces at the manufacturing facility. The product was distributed to retailers and government facilities across the Southwest.
Product
Fresh Take Crave Away Beef Cheesesteak Sub Sandwich; 6oz PLASTIC CONTAINER; Best By: 05/09/2025 - 05/19/2025 UPC# 8 06795 61442 8
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0863-2025·2025-06-11
Fresh & Ready Foods Roasted Chicken Sandwich Recalled for Listeria
Fresh & Ready Foods is recalling Roasted Chicken Multigrain Sandwiches due to Listeria monocytogenes detected on food contact surfaces at the manufacturing facility. Affected products have best-by dates May 9-12, 2025.
Product
Fresh & Ready Foods Roasted Chicken Multigrain Sandwich, 6.5oz. plastic container. Best buy: 05/09/2025-05/12/2025 UPC# 6 82906 89063 5
Category
Food
Distribution
4 states
CriticalFDA (Food)·H-0002-2025·2025-06-11
Cucumbers from Bedner Growers recalled due to Salmonella risk
Bedner Growers is recalling 126,159 cartons of wholesale cucumbers distributed in Florida due to potential Salmonella contamination. Cucumbers shipped May 3-12, 2025 may be affected.
Product
Cucumbers, Wholesale Produce Supply, Bedner Growers, Inc. 10066 Lee Road Boynton Beach, FL 33473 (561)733-5490. Cucumbers were packaged in cardboard shipping boxes to customers with packaging sizes consisting of 68, 36, or 24 count per box.
Category
Food
Distribution
0 states
CriticalFDA (Food)·F-0879-2025·2025-06-11
Fresh & Ready Foods PB&J Sandwich Recalled for Listeria Contamination
Fresh & Ready Foods is recalling PB&J on White Sandwiches due to Listeria monocytogenes detected on food contact surfaces in its manufacturing facility. The recall affects approximately 139,863 units distributed to military and civilian facilities in the Southwest.
Product
Fresh & Ready Foods PB&J on White Sandwich, 5oz. plastic container. Best buy: 05/09/2025-05/12/2025 UPC# 6 82906 90620 6
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0866-2025·2025-06-11
Fresh & Ready Foods Mike's Tuna Mac Pasta Recalled for Listeria
Fresh & Ready Foods Mike's Tuna Mac Pasta in 9-ounce containers (best buy May 9-12, 2025) is recalled because Listeria Monocytogenes was detected on food contact surfaces at the manufacturing facility. About 139,863 units were distributed across the Southwest and military facilities.
Product
Fresh & Ready Foods Mike's Tuna Mac Pasta, 9oz. plastic container. Best buy: 05/09/2025-05/12/2025 UPC# 6 82906 89065 6
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0892-2025·2025-06-11
City Point Italian Hoagie Sub Sandwiches recalled for Listeria risk
City Point Market Italian Hoagie Sub Sandwiches are recalled for Listeria contamination detected at the manufacturing facility. The affected products were distributed in the Southwest and to military facilities.
Product
City Point Market Fresh Food to Go Italian Hoagie Sub Sandwich; 6oz, PLASTIC CONTAINER Best By: 05/09/2025 - 05/18/2025 UPC# 4 00694 44201 6
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0825-2025·2025-06-11
Gluten-free sourdough bread recalled for undeclared egg allergen
NEW GRAINS GLUTEN FREE BAKERY is recalling approximately 42 units of its Artisan Sourdough Bread (32 oz) distributed in Utah due to printing defects that render the egg allergen declaration illegible.
Product
Artisan Sourdough Bread: Gluten-free sourdough bread, vacuum-sealed clear plastic, 32 oz, 1 loaf/package Ingredients: White rice flour, Water, Eggs, Tapioca flour, Sugar, Potato flour, Palm fruit oil, Yeast, Psyllium husk powder, Vinegar, Sea salt, Xanthan gum, Powdered sugar.
Category
Food
Distribution
0 states
CriticalFDA (Food)·H-0004-2025·2025-06-11
Ukrop's Marinated Cucumber Salad Recalled Due to Salmonella Risk
Ukrop's Homestyle Foods LLC is recalling Marinated Cucumber Salad with Sell By dates 5/11/25 through 5/26/25 due to potential Salmonella contamination from cucumbers supplied by Bedner Farms. Affected products were distributed in KY, NC, OH, VA, and WV.
Product
Ukrop's Marinated Cucumber Salad INGREDIENTS: Cucumber, distilled vinegar***apple cider vinegar, sugar, red onion, water, canola oil***NET WT 16 OZ (1LB/454g) UPC 7 22515 24902 5; NET WT 36 OZ (2.25LB/1.02kg) UPC 7 22515 25224 7; NET WT 5LB (2.27kg) UPC 7 22515 29354 7 Ukrop's Ho
Category
Food
Distribution
5 states
CriticalFDA (Food)·F-0877-2025·2025-06-11
Roast Beef Sandwich Recalled for Listeria by Fresh & Ready Foods
Fresh & Ready Foods is recalling Roast Beef on Wheat Sandwiches after Listeria Monocytogenes was detected on food contact surfaces at the manufacturing facility. The recall affects approximately 139,863 units distributed across the Southwest and to military facilities.
Product
Fresh & Ready Foods Roast Beef on Wheat Sandwich, 5oz. plastic container. Best buy: 05/09/2025-05/12/2025 UPC# 6 82906 89289 3
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0811-2025·2025-06-04
Mauna Loa Dark Chocolate Macadamias Recalled for Undeclared Almond and Cashew
Mauna Loa Dark Chocolate Covered Macadamias recalled for undeclared almond and cashew allergens. The recall affects specific lot numbers distributed across multiple states.
Product
Mauna Loa Dark Chocolate Covered Macadamias product is a snack product and packaged in 0.6oz and 4oz plastic flexible pouch. Dist. By Mauna Loa Macadamia Nut Corp. Kea au, Hawaii 96749, USA. Label declares Contains: Tree Nuts (Macadamia), Milk and Soy. Each master case contains
Category
Food
Distribution
16 states
CriticalFDA (Food)·F-0810-2025·2025-05-28
Zeke's Daddy's Granola Recalled for Undeclared Tree Nut Allergens
BBF Massachusetts LLC is recalling Zeke's Daddy's Granola because it contains undeclared almond and cashew. People with tree nut allergies face risk of serious allergic reaction.
Product
Zeke's Daddy's Granola; INGREDIENTS: Whole grain rolled oats, maple syrup, expeller pressed canola oil, coconut, brown sugar, molasses, cinnamon, salt, natural flavor; Contains coconut; Manufactured in a facility that uses peanuts, tree nuts, soy, wheat, sesame, and milk; 30 LBS;
Category
Food
Distribution
1 state
CriticalFDA (Devices)·Z-1760-2025·2025-05-28
Centerline Biomedical IOPS Guidewire 2 Coating Delamination Risk Recall
Centerline Biomedical is recalling IOPS Guidewire 2 devices (Lot 2404-2005) because the coating may delaminate during use, potentially compromising device function in critical vascular procedures.
Product
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1746-2025·2025-05-28
Vascular surgical stapler device risks inadvertent lockout during procedures
The Endopath Echelon Vascular White Reload surgical stapler may inadvertently lock during use, preventing cutting or stapling and requiring additional removal steps. Risk of bleeding and hemorrhage if device cannot be removed from tissue.
Product
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0771-2025·2025-05-21
Bonya Coconut Yogurt Parfait recalled for undeclared almonds
Knockroe Inc recalled 4,812 units of Bonya Coconut Yogurt Parfait for undeclared almonds across New York, Pennsylvania, Massachusetts, and New Jersey. Consumers with almond allergies should not consume this product.
Product
Bonya Coconut Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate .
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0761-2025·2025-05-14
Ankimo Monkfish Liver Recalled for Undeclared Milk Allergen
Ankimo branded monkfish liver is being recalled due to undeclared milk, an allergen. Consumers with milk allergies should not consume this product.
Product
Ankimo branded Monkfish Liver; NET WT. 7 OZ (200g); Imported and DIST. BY: JJWV Marketing Corporation; Santa Fe Springs, CA 90670 USA; UPC# 8 94042 00256 2
Category
Food
Distribution
0 states
CriticalFDA (Devices)·Z-1668-2025·2025-05-14
Infusion Pump False Alarms May Interrupt Necessary Therapy
Smiths Medical CADD-Solis VIP ambulatory infusion pumps may trigger false upstream occlusion alarms that interrupt patient therapy. Therapy interruption can cause serious injury or death.
Product
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-0
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0762-2025·2025-05-14
Trader Joe's Sesame Miso Salad with Salmon recalled for undeclared milk
Trader Joe's Sesame Miso Salad with Salmon (UPC 00773164) is being recalled due to undeclared milk. The recall affects 1,435 units distributed to Trader Joe's stores across 18 states.
Product
Trader Joe's Sesame Miso Salad with Salmon, net wt. 10.25oz., in clear plastic clamshell container, UPC 00773164
Category
Food
Distribution
18 states
CriticalFDA (Devices)·Z-1631-2025·2025-05-07
GE Carestation 650 A1 anesthesia system ventilation failure
The GE Carestation 650 A1 anesthesia system fails to provide effective ventilation in Volume Control Ventilation (VCV) mode, though ventilation is available in alternative modes.
Product
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0724-2025·2025-04-30
Zaarah Herbals Rasayan Churan Recalled Due to Elevated Lead Levels
Zaarah Herbals brand Rasayan Churan herbal powder has been recalled due to elevated lead contamination. The affected product was distributed in New York, Connecticut, New Jersey, and California.
Product
Zaarah Herbals brand Rasayan Churan; packaged in 100g clear jars with gold lids; UPC:6 35028 99966 3
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-0723-2025·2025-04-30
Zaarah Herbals Vasaka Powder recalled for elevated lead contamination
Zaarah Herbals brand Vasaka Powder is being recalled due to elevated lead contamination. The herbal powder, sold in 100g jars, poses significant health risks to consumers.
Product
Zaarah Herbals brand Vasaka Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99967 0
Category
Food
Distribution
4 states
CriticalFDA (Devices)·Z-1528-2025·2025-04-23
Ballard Closed Suction Catheters recalled due to lack of sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters due to lack of sterility assurance, which poses a serious infection risk.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1524-2025·2025-04-23
Ballard Closed Suction Catheters recalled due to lack of sterility assurance
Avanos Medical is recalling 9,020 units of Ballard Closed Suction Catheters (Model 220135) due to lack of sterility assurance. The affected devices were distributed worldwide and may pose an infection risk.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0633-2025·2025-03-19
Ulker Biskrem Cocoa Biscuits Recalled for Undeclared Wheat and Egg
ZB Importing LLC recalls Ulker Biskrem Cocoa Biscuits due to undeclared wheat and egg. Consumers with these allergies should not consume the product.
Product
Ulker Biskrem Cocoa Biscuit, item 8836, 10.6oz foil pack, 8 per case, UPC 8690504114628
Category
Food
Distribution
36 states
CriticalFDA (Food)·F-0609-2025·2025-03-19
Aleppo Tahini Sesame Paste recalled due to Salmonella contamination
Turkana Food Inc. is recalling Aleppo Tahini Sesame Paste because the product tested positive for Salmonella. The recalled product was distributed to 23 states.
Product
Aleppo Tahini Sesame Paste, 32oz, Plastic jar, 1lb (16oz), 12 per case
Category
Food
Distribution
23 states