The Recall Desk

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.

401–425 of 758

  • CriticalFDA (Devices)·Z-2223-2023·2023-08-02

    LINEAR intra-aortic balloon catheter introducer dilator fracture risk

    Datascope's LINEAR intra-aortic balloon catheters may develop a fractured introducer dilator that can injure blood vessels or cause dangerous blockages. The company has received 10 complaints including 1 death and 3 serious adverse events.

    Product
    LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2217-2023·2023-08-02

    Datascope SENSATION 7 Intra-Aortic Balloon Catheters Recalled for Introducer Fracture Risk

    The SENSATION 7 Fr. intra-aortic balloon catheter introducer dilator may fracture during insertion, potentially damaging blood vessels and requiring surgery. One death has been reported among 10 total complaints.

    Product
    SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2219-2023·2023-08-02

    Intra-Aortic Balloon Catheter kits recalled due to dilator fracture risk

    Datascope's MEGA 7.5Fr. intra-aortic balloon catheter kits may have introducers that fracture during insertion, risking arterial damage and embolization. The firm has received 10 complaints including 3 serious events and 1 death.

    Product
    MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2224-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Set fracture causes vascular injury

    Datascope Corp. recalls Reinforced Introducer Sets because the dilator may fracture during catheter insertion, risking arterial damage and embolization. One patient death has been reported.

    Product
    REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2220-2023·2023-08-02

    MEGA Intra-Aortic Balloon Catheter Introducer Fracture Poses Arterial Injury Risk

    Datascope's MEGA 8Fr. intra-aortic balloon catheter introducer may fracture during insertion, leaving fragments that can damage blood vessels. The firm has reported 10 complaints, including 1 death.

    Product
    MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D68
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2221-2023·2023-08-02

    Datascope SENSATION PLUS Intra-Aortic Balloon Catheter Dilator Fracture Risk

    Datascope's SENSATION PLUS intra-aortic balloon catheter dilator may fracture during insertion, potentially damaging the femoral artery or aorta. The firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

    Product
    SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2216-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Dilator Fracture During Insertion

    The YAMATO PLUS intra-aortic balloon catheter's introducer dilator may fracture during insertion, risking arterial damage, aortic damage, or blood clots. Datascope has received 10 complaints, including 1 death and 3 serious adverse events.

    Product
    YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIE
    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 I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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. 4
    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 (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-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 (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. Schn
    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-1198-2023·2023-07-12

    Ole Chicken Fajita Seasoning recalled due to potential Salmonella contamination

    Newly Weds Foods, Inc. is recalling Ole Chicken Fajita Seasoning (product code MT559558) because it may contain Salmonella. The product was distributed across the United States and Canada.

    Product
    S04774 OLE CHICKEN FAJITA SEASONING X5 50.00 BOX
    Category
    Food
    Distribution
    0 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
    0 states
  • 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
    0 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
    0 states
  • CriticalFDA (Food)·F-1047-2023·2023-07-12

    W Crispy Chicken Batter Mix recalled due to Salmonella contamination risk

    Newly Weds Foods, Inc. is recalling W Crispy Chicken Batter Mix due to potential Salmonella contamination. The product was distributed across multiple U.S. states and Canada.

    Product
    A86554 W CRISPY CHICKEN BATTER MIX X2 50.00 BAG
    Category
    Food
    Distribution
    0 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
    0 states