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.

926–950 of 7451

CriticalFDA (Devices)·Z-2218-2023·2023-08-02
Intra-Aortic Balloon Catheter Introducer Dilator May Fracture During Insertion
Datascope TRANS-RAY IAB catheters may have introducer dilators that fracture during insertion, risking arterial damage or blood clots. The firm reports 1 death and 3 serious injuries.
Product
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR.…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2222-2023·2023-08-02
Intra-aortic balloon catheter recall due to introducer dilator fracture risk
Datascope Corp. is recalling SENSATION PLUS 8Fr. intra-aortic balloon catheters because the introducer dilator may fracture during insertion, risking blood vessel damage and surgical intervention. The company received 10 complaints, including 1 death.
Product
SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1261-2023·2023-07-26
Frozen Cherries Recalled Due to Potential Listeria Contamination
SunOpta Grains and Foods Inc. is recalling frozen cherries sold under Great Value, Good & Gather, and Best Choice brands nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.
Product
Cherries packaged under the following brands and sizes: 1. Great Value Dark Sweet Cherries, Pitted. Net Wt 16 oz (1 lb) 454g, UPC 0 78742-11209 1. Keep Frozen. Distributed by: Walmart Inc., Bentonville, AR 72716 2. Good & Gather Dark Sweet Whole Pitted Cherries. Net…
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2016-2023·2023-07-26
Olympus Bronchovideoscope Recalled for Endobronchial Combustion Risk
Olympus is recalling 17,609 bronchovideoscope units nationwide due to complaints of endobronchial combustion during therapeutic laser procedures, which poses a fire and burn risk to patients.
Product
Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1267-2023·2023-07-26
365 Whole Foods Organic Tropical Fruit Medley recalled due to Listeria contamination risk
365 Whole Foods Market Organic Tropical Fruit Medley is recalled nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume this product.
Product
365 Whole Foods Market Organic Tropical Fruit Medley. Strawberries, Mangoes, Bannas & Pineapples. Net Wt 32 oz (2 lb) 907g. UPC 0 99482-45715 0. Keep Frozen. Distributed by: Whole Foods Market, Austin, TX 78703
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1236-2023·2023-07-19
FDA Recalls Rader Farms Organic Fresh Start Smoothie for Hepatitis A
Rader Farms Organic Fresh Start Smoothie, a frozen fruit and vegetable blend, has been recalled due to potential Hepatitis A contamination. The recall affects 62,380 bags distributed across 31 states.
Product
Rader Farms Organic Fresh Start Smoothie Blueberry, Strawberry, Raspberry, Kale, Spinach. Item # 1399671. Frozen, packed into 8oz. flexible plastic pouches and six 8oz pouches are packed into one flexible plastic bag. Net Wt. 48oz. UPC on retail bag: 8 84038 08326 2. A total…
Category
Food
Distribution
32 states
CriticalFDA (Drugs)·D-0921-2023·2023-07-19
Artificial Tears Eye Drops Recalled for Bacterial Contamination
Delsam Pharma's Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. Consumers should stop using affected products immediately.
Product
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1240-2023·2023-07-19
Jumbo Deviled Crabs recalled for undeclared milk and sesame allergens
SANTOS FROZEN FOODS is recalling Jumbo Deviled Crabs (6oz packages) because they contain undeclared milk and sesame seeds. Consumers with allergies or sensitivities to these allergens should not consume this product.
Product
Jumbo Deviled Crabs, 6oz
Category
Food
Distribution
0 states
CriticalFDA (Drugs)·D-0938-2023·2023-07-19
Prescription albuterol inhalers recalled nationwide due to defective valve seals
Cipla USA is recalling 278,538 albuterol sulfate inhalers nationwide with specific lot numbers due to defective valve gaskets that cause empty inhalers or medication leakage. Check your lot number and contact your healthcare provider if affected.
Product
ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1242-2023·2023-07-19
Multiple Pretzel Brands Recalled for Undeclared Milk Allergen
Honey mustard pretzel products from multiple brands are being recalled due to potential undeclared milk. The recall affects 334,357 bags distributed nationwide.
Product
1. Hy-Vee Honey Mustard Braided Pretzels, 10oz poly bags, UPC: 75450-24309, 12 pack; 2. Dakota Style Honey Mustard Pretzel Kravings, 10oz poly bags, UPC 84872-60031, 12 pack and 6 pack; 3. Four Brothers Honey Mustard Pretzels, 10oz poly bags, UPC: 33147-89145, 12 pack; 4.…
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1212-2023·2023-07-12
Lemon Garlic Seasoning for Chicken Recalled for Salmonella Contamination Risk
Newly Weds Foods is recalling Lemon Garlic Seasoning for Chicken (code SE280822) due to potential Salmonella contamination. The product was distributed across 28 US states and Canada.
Product
S16997 LEMON GARLIC SEASONING FOR CHICKEN P1 50.00 BOX
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1202-2023·2023-07-12
Newly Weds Foods ADNE-ARC Blend Recalled Due to Salmonella Risk
Newly Weds Foods is recalling its ADNE-ARC Blend due to possible Salmonella contamination. The product was distributed across multiple US states and Canada.
Product
S09557 ADNE-ARC BLEND X1 36.00 BAG
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1175-2023·2023-07-12
Spice Blend Recalled Nationwide for Potential Salmonella Contamination
Newly Weds Foods is recalling its spice blend product due to potential Salmonella contamination. The product was widely distributed across 28 U.S. states and Canada.
Product
G95516 SPICE BLEND FOR 01851 X1 34.20 BAG
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1109-2023·2023-07-12
Breader Product Recalled Due to Potential Salmonella Contamination
Newly Weds Foods is recalling breader products that may contain Salmonella. The product was distributed across 28 US states and Canada.
Product
B97608 BREADER X3 50.00 BAG
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1145-2023·2023-07-12
Meatball Seasoning Recalled Due to Potential Salmonella Contamination
Newly Weds Foods is recalling G60040 Meatball Seasoning due to potential Salmonella contamination. The product was distributed across 28 U.S. states and Canada.
Product
G60040 MEATBALL SEASONING X1 50.00 BAG
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1180-2023·2023-07-12
Fajita seasoning recalled for potential Salmonella contamination
Newly Weds Foods, Inc. is recalling Fajita Seasoning (G97638) due to possible Salmonella contamination in widely distributed product batches.
Product
G97638 FAJITA SEASONING X1 50.00 BAG
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1177-2023·2023-07-12
Lotta Zing Sauce Mix recalled for potential Salmonella contamination
Newly Weds Foods is recalling Lotta Zing Sauce Mix due to potential Salmonella contamination. Consumers with affected products should not use them.
Product
G96378 LOTTA ZING SAUCE MIX X2 15.00 CASE
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1126-2023·2023-07-12
Newly Weds Foods Issues Salmonella Recall for Smoky Injection
Newly Weds Foods is recalling Smoky Injection X2, a food injection product, due to potential Salmonella contamination. The product was distributed across multiple US states and Canada.
Product
G27424 SMOKY INJECTION X2 50.00 BAG
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1137-2023·2023-07-12
Savory Chicken Seasoning Recalled Due to Potential Salmonella Contamination
Newly Weds Foods, Inc. is recalling Savory Chicken Seasoning X5 products distributed across 27 U.S. states and Canada because they may contain Salmonella.
Product
G39203 SAVORY CHICKEN SEASONING X5 50.00 BAG
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1038-2023·2023-07-12
Seasoned Flour Recalled Due to Potential Salmonella Contamination
Newly Weds Foods is recalling A52541 seasoned flour (product code MT110322C) due to potential Salmonella contamination. The product has been distributed across the United States and Canada.
Product
A52541 SEASONED FLOUR X1 50.00 BAG
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1148-2023·2023-07-12
Jalapeno Beef Stick Seasoning Recalled for Possible Salmonella Contamination
Newly Weds Foods is recalling Jalapeno Beef Stick Seasoning #1912 due to possible Salmonella contamination affecting approximately 6.5 million pounds. Consumers should not use the affected product.
Product
G62843 JALAPENO BEEF STICK SEASONING #1912 48.00 CASE
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1034-2023·2023-07-12
Newly Weds Foods Batter Mix Recalled for Potential Salmonella Contamination
Newly Weds Foods, Inc. is recalling approximately 6.5 million pounds of batter mix due to potential Salmonella contamination. The product was distributed across 28 U.S. states and Canada.
Product
A28460 BATTER MIX X1 50.00 BAG
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1194-2023·2023-07-12
BBQ Seasoning Recalled Due to Possible Salmonella Contamination
Newly Weds Foods is recalling Chix BBQ Seasoning due to possible Salmonella contamination. The product was distributed to 28 US states and Canada.
Product
S02192 CHIX BBQ SEASONING X1 52.72 BAG
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1026-2023·2023-07-12
Batter Mix Products Recalled for Potential Salmonella Contamination
Newly Weds Foods is recalling A20180 Batter Mix in 50-pound bags due to potential Salmonella contamination. The recall affects products distributed across 28 US states and Canada.
Product
A20180 BATTER MIX X4 50.00 BAG
Category
Food
Distribution
28 states
CriticalFDA (Food)·F-1082-2023·2023-07-12
Newly Weds Foods Issues Salmonella Contamination Recall for Breading Product
Newly Weds Foods, Inc. is recalling approximately 6.5 million pounds of breading product due to potential Salmonella contamination. The affected product was distributed across multiple U.S. states and Canada.
Product
B54907 BREADER X1 50.00 BAG
Category
Food
Distribution
28 states