The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

1226–1250 of 4878

  • SevereCPSC·24130·2024-02-22

    Bulldog Biometric Firearm Safes Recalled Due to Lock Failure Risk

    Bulldog Cases is recalling about 33,500 Magnum Biometric Pistol Vaults because the biometric lock can fail and be opened by unauthorized users, creating a serious injury hazard and risk of death when firearms are stored in the safe.

    Product
    Bulldog Biometric Firearm Safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0874-2024·2024-02-21

    Mighty Fine Chocolate Ice Cream Recalled for Undeclared Peanuts

    Byrne Dairy, Inc is recalling Mighty Fine Chocolate Ice Cream because it contains undeclared peanuts. Consumers with peanut allergies should not consume this product.

    Product
    Mighty Fine Chocolate Ice Cream
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0903-2024·2024-02-21

    Mexican Style Quinoa Salad Recalled for Undeclared Soy and Egg Allergens

    Hans Kissle Company is recalling Mexican Style Quinoa Salad due to undeclared soy and egg allergens. The product was distributed in the Northeast and may pose serious risk to consumers with allergies.

    Product
    MEXICAN STYLE QUINOA SALAD
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0865-2024·2024-02-21

    Dragonfly Jelly Bar Handbags and Backpacks Recalled for Choking Hazard

    U.S. Tov, Inc. is recalling Dragonfly Jelly Bar Handbags and Backpacks due to a potential choking hazard from konjac. The products were distributed nationwide.

    Product
    Dragonfly Jelly Bar Handbag 11.64oz, 17.63oz UPC Code 721557357156, 721557357163 Dragonfly Jelly Bar Backpack 7.93oz, 28.22oz UPC Code 721557357170, 721557357187
    Category
    Food
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0958-2024·2024-02-21

    GE Healthcare Care Plus and Lullaby incubators recalled for bedside panel latching defect

    GE Healthcare is recalling 1,410 neonatal incubators worldwide because bedside panels and portholes can appear closed while not properly latched. If impacted, they may fall open and fail to protect patients from falls.

    Product
    GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0961-2024·2024-02-21

    GE Healthcare Incubators Bedside Panel Latch Failure Poses Fall Risk

    GE Healthcare incubators have defective bedside panels that may appear closed but not be properly latched, creating a patient fall risk when the panels disengage upon impact.

    Product
    GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0866-2024·2024-02-21

    Utz Wavy Originals Potato Chips recalled for undeclared milk allergen

    Utz Wavy Originals Potato Chips (2.75 oz) distributed in New York may contain undeclared milk and could pose a risk to people with milk allergies.

    Product
    Utz Wavy Originals Potato Chips, Net WT. 2.75 oz (78g), UPC 0-41780-19014-7.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0960-2024·2024-02-21

    GE Healthcare incubator bedside panel may disengage and fall open

    The bedside panel on GE Healthcare Care Plus incubators may appear closed while unlatched. If impacted, the panel can fall open, exposing patients to injury risk.

    Product
    GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0869-2024·2024-02-21

    Al Amir Baba Ghannooj Recalled for Undeclared Sesame Allergen

    Al Amir Fresh Foods Baba Ghannooj Grilled Eggplant is recalled for undeclared sesame. The product contains tahini but the label does not list sesame as an ingredient, posing a risk to consumers with sesame allergies.

    Product
    Al Amir Fresh Foods Baba Ghannooj Grilled Eggplant, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. UPC on 8oz container: 7 55134 12342 1. The recalled product label declares: Ingredients: Fresh Grilled Eggplant, Tahini Paste, Garlico (F
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0875-2024·2024-02-21

    Fresh Express Chopped Salad Kit Southwest Recalled for Listeria Risk

    Fresh Express Incorporated is recalling Chopped Salad Kit Southwest products due to potential Listeria monocytogenes contamination in the cheese condiment pack. Consumers should not consume the product.

    Product
    Chopped Salad Kit Southwest with condiments(toppings that include cheese), labeled salad bag (Green Cabbage, Green Leaf Lettuce, Kale, Red Cabbage, Carrots, Green Onions, Tortilla Strips, Cheddar Cheese, and Chipotle Ranch Dressing), Net Wt 13.4 oz, 6 bags per case. UPC 681131305
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0876-2024·2024-02-21

    Fresh Express Salad Kit Recalled for Potential Listeria Contamination

    Fresh Express Kit Salsa! Ensalada salad kits are recalled for potential Listeria monocytogenes contamination in the cheese condiment. The affected 12.1 oz bags were distributed to AL, FL, GA, CA, UT, WA, and Canada.

    Product
    Fresh Express Kit Salsa! Ensalada with condiments(toppings that include cheese), labeled salad bag (Iceberg & Romaine Lettuce, Salsa Ranch Dressing, Nacho Taco Seasoned Cheese Yellow & Blue Tortilla Strips), Net Wt 12.1 oz, 6 bags per case. UPC 071279309026
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0980-2024·2024-02-21

    Impella Cardiac Support Catheters: Risk of Left Ventricle Perforation

    Impella cardiac catheters are being recalled due to risk of left ventricle perforation during operator use. The FDA has classified this Class I recall affecting 91,914 units worldwide.

    Product
    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0867-2024·2024-02-21

    Al Amir Fresh Foods Hummus Recalled for Undeclared Sesame Allergen

    Al Amir Fresh Foods Classic Hummus Creamy Garbanzo is recalled because it contains sesame (tahini) but the label does not declare sesame as an allergen. Consumers with sesame allergies may experience allergic reactions.

    Product
    Al Amir Fresh Foods Classic Hummus Creamy Garbanzo, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. UPC on 8oz container: 7 55134 12341 4. The recalled product label declares: Ingredients: Garbanzo Beans, Tahini Paste, Garlico (Fresh G
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0959-2024·2024-02-21

    GE Healthcare Care Plus Incubator Hood Latching Defect Increases Fall Risk

    GE Healthcare incubator hoods can appear closed but may not be properly latched, posing a fall risk if patients impact an unsecured panel.

    Product
    GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0962-2024·2024-02-21

    GE Healthcare Lullaby Incubator bedside panels may fail to latch properly

    GE Healthcare Lullaby Incubator bedside panels and portholes may appear closed but not be properly latched. If impacted, these panels can disengage and fall open, creating a fall risk for patients.

    Product
    GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0868-2024·2024-02-21

    Al Amir Fresh Foods Hummus recalled for undeclared sesame allergen

    Al Amir Fresh Foods Harissa Spicy Hummus With a Kick is being recalled due to an undeclared sesame allergen. The product declares tahini but not sesame, which could cause serious allergic reactions in people with sesame sensitivity.

    Product
    Al Amir Fresh Foods Harissa Spicy Hummus With a Kick, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. UPC on 8oz container: 7 55134 12352 0. The recalled product label declares: Ingredients: Garbanzo Beans, Tahini Paste, Garlico (Fresh G
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0957-2024·2024-02-21

    GE Healthcare neonatal incubator bedside panels may fail to latch properly

    GE Healthcare is recalling neonatal incubators because the bedside panel can appear closed while unlatched. Impact could cause it to fall open, risking patient injury.

    Product
    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0859-2024·2024-02-14

    Cardinal Health Monoject Syringes Removal Due to Manufacturing Changes

    Cardinal Health is removing Monoject brand syringes due to manufacturing changes and rebranding efforts. The removal includes Luer-Lock and ENFit connection models distributed nationwide in the US and Canada.

    Product
    Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0851-2024·2024-02-14

    Cardinal Health Monoject Syringes and Enteral Syringes Removed

    Cardinal Health is removing all Monoject sterile syringes and enteral syringes due to manufacturing changes and rebranding efforts. These products are distributed across the U.S. and Canada.

    Product
    Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0310-2024·2024-02-14

    FDA Recalls Rugby Lubricating Tears Eye Drops for Non-Sterility

    Rugby brand Lubricating Tears Eye Drops have been recalled nationwide for non-sterility. Kilitch Healthcare India Limited initiated the voluntary recall of 56,520 bottles due to potential contamination concerns.

    Product
    Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0849-2024·2024-02-14

    Cardinal Health Enteral Feeding Syringes Recalled for Pump Compatibility Issues

    Cardinal Health Monoject enteral syringes in sizes 6mL to 60mL have compatibility issues with certain feeding pumps and may not properly connect. Cardinal Health recommends not using these syringes with enteral feeding pumps.

    Product
    Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0842-2024·2024-02-14

    HeartMate Touch Communication System recalled for software pump operation defects

    Thoratec Corp. is recalling HeartMate Touch Communication Systems (1,560 units) due to software and controller defects causing unexpected LVAD pump starts or stops, potentially affecting patient safety.

    Product
    1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0853-2024·2024-02-14

    Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes

    Cardinal Health is removing all sizes of Monoject sterile syringes and enteral syringes from the market due to manufacturing and rebranding changes. Products were distributed in the US and Canada.

    Product
    Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0852-2024·2024-02-14

    Cardinal Health Monoject Sterile Syringes Recalled for Manufacturing Change

    Cardinal Health is recalling Monoject sterile syringes due to manufacturing changes. The recall affects Luer-Lock and Enteral syringe models distributed in the US and Canada.

    Product
    Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
    Category
    Medical Device
    Distribution
    Distributed nationwide