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.

2501–2525 of 4878

  • SevereFDA (Devices)·Z-1485-2023·2023-05-17

    ANGIOGUARD RX/XP Guidewire System May Separate During Medical Procedures

    The ANGIOGUARD RX/XP Emboli Capture Guidewire System may separate during medical procedures, potentially delaying treatment or requiring unplanned intervention. The recall affects 471 units distributed worldwide.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1490-2023·2023-05-17

    ANGIOGUARD RX/XP Emboli Capture Guidewire System May Separate During Procedures

    ANGIOGUARD RX/XP emboli capture guidewire systems may separate from their delivery sheaths during interventional procedures, potentially causing stroke. Cordis is recalling 56 units distributed worldwide.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0832-2023·2023-05-17

    Meijer Chicken Cobb Salad Recalled Due to Listeria Contamination Risk

    Meijer Inc. is recalling Fresh From Meijer Chicken Cobb Salad due to potential Listeria monocytogenes contamination. The product was distributed to Meijer stores in six states.

    Product
    Fresh From Meijer Chicken Cobb Salad 8.8 Oz UPC - 719283679321
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1427-2023·2023-05-17

    Blue Rhino G2 Tracheostomy Introducer Sets Recalled for Unsecure Connections

    Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets due to unsecure connections with 15mm caps and circuit components that may disconnect during medical procedures.

    Product
    Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1495-2023·2023-05-17

    Emboli Capture Guidewire System Separation Risk Recalls ANGIOGUARD RX/XP

    Cordis US Corp is recalling ANGIOGUARD RX/XP Emboli Capture Guidewire Systems worldwide due to potential separation of the delivery system and capture sheath during procedures, which could cause stroke or require emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0840-2023·2023-05-17

    Salad Product Recalled by Meijer for Listeria Contamination

    Meijer Inc is recalling Fresh From Meijer Cranberry Spinach Shareable Salad due to potential Listeria monocytogenes contamination. The product was distributed to Meijer stores in Michigan, Indiana, Illinois, Ohio, Kentucky, and Wisconsin.

    Product
    Fresh From Meijer Cranberry Spinach Shareable Salad 12 Oz UPC - 708820304321
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0567-2023·2023-05-17

    Atovaquone Oral Suspension Recalled for Bacillus cereus Contamination

    Camber Pharmaceuticals is recalling Atovaquone Oral Suspension due to contamination by Bacillus cereus bacteria. The contamination was discovered during testing of repackaged medication.

    Product
    ATOVAQUONE — ATOVAQUONE (ATOVAQUONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0836-2023·2023-05-17

    Fresh From Meijer Shareable Garden Salad Recalled for Listeria

    Fresh From Meijer Shareable Garden Salad 11.5 oz is being recalled due to potential Listeria monocytogenes contamination. The recall affects salads distributed to Meijer stores across six states with a sell-by date of 3/31/2023.

    Product
    Fresh From Meijer Shareable Garden Salad 11.5 Oz UPC - 713733295376
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0827-2023·2023-05-17

    Revolution Farms Sesame Ginger Crunch Salad Kit Recalled for Listeria Monocytogenes

    Revolution Farms Sesame Ginger Crunch 6oz salad kits (UPC 856791008233, 'Sell By 3/23/23') are recalled due to potential Listeria monocytogenes contamination. Affected units were distributed in Michigan, Ohio, and Wisconsin.

    Product
    Revolution Farms Sesame Ginger Crunch 6oz salad kit in plastic container UPC 856791008233
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0828-2023·2023-05-17

    Revolution Farms Salad Kits Recalled for Listeria Contamination

    Revolution Farms is recalling Traverse City Cherry 6-ounce salad kits due to potential Listeria monocytogenes contamination. Affected products were distributed in Michigan, Ohio, and Wisconsin.

    Product
    Revolution Farms Traverse City Cherry 6oz salad kit in plastic container UPC 856791008226
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1493-2023·2023-05-17

    ANGIOGUARD Emboli Capture Guidewire System recalled due to potential device separation

    Cordis US Corp's ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled by the FDA (Class I) because the delivery system and capture sheath may separate during medical procedures, potentially requiring emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1428-2023·2023-05-17

    Cook Blue Rhino G2 Tracheostomy Introducer Trays Recalled for Connection Defect

    Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays because the device connectors are not making secure connections with 15mm caps and other circuit components, resulting in unsecure connections.

    Product
    Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1492-2023·2023-05-17

    ANGIOGUARD Emboli Capture Guidewire System Recalled Due to Device Separation

    The FDA has recalled the ANGIOGUARD RX/XP Emboli Capture Guidewire System because the delivery system and capture sheath could separate during use, potentially causing stroke or requiring emergency surgery.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1483-2023·2023-05-17

    ANGIOGUARD RX / XP Emboli Capture Guidewire System separation during procedures

    The ANGIOGUARD RX / XP emboli capture guidewire system may separate from its delivery sheath during medical procedures, potentially leading to stroke or complications requiring emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1486-2023·2023-05-17

    Emboli Capture Guidewire System Recalled Due to Potential Component Separation

    Cordis US Corp recalls 54 units of the ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of device components. This could delay procedures or result in unplanned intervention, including possible stroke.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
    Category
    Medical Device
    Distribution
    0 states
  • SevereCPSC·23201·2023-05-11

    Peloton Exercise Bikes Recalled for Seat Post Breakage and Fall Risk

    Peloton is recalling approximately 2.2 million Model PL01 exercise bikes because the seat post assembly can break during use, causing users to fall. The company has received 35 reports of seat post breakage, including 13 reports of injuries such as fractured wrists, lacerations, and bruises.

    Product
    Peloton Bikes Model PL01
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·23755·2023-05-11

    Ski-Doo Snowmobiles Recalled for Fire Hazard from Fuel Leaks

    BRP U.S. Inc. is recalling about 12,500 Ski-Doo snowmobiles from model years 2021 and 2022 because a fuel injector hose retainer screw can loosen, cause fuel leaks, and pose a fire hazard. Four fires have been reported.

    Product
    Ski-Doo snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0815-2023·2023-05-10

    Tandoori Roasted Chana Recalled Due to Undeclared Milk Allergen

    Tandoori Roasted Chana (chickpeas) from Jabsons Foods is recalled because it contains undeclared milk, a major allergen. Consumers with milk allergies should not consume this product.

    Product
    Tandoori Roasted Chana (Chick Peas); Net. Wt 4.94 oz Laminated Pouches; packed in cases consisting of 24 pouches
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0774-2023·2023-05-10

    Dark Chocolate Pineapple Bites Recalled Due to Undeclared Milk

    Salento Organics has recalled Dark Chocolate Pineapple Bites due to undeclared milk. The affected product contains milk not identified on the label, posing a risk to consumers with milk allergies.

    Product
    Salento Organics, Dark Chocolate Pineapple Bites, Net WT. 4oz (113G)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0573-2023·2023-05-10

    Unapproved Drug Capsule Recalled for Undeclared Sexual Enhancement Ingredients

    DYNAMITE SUPER capsule is being recalled nationwide because it was marketed without FDA approval and contains undeclared sildenafil and tadalafil, active ingredients used in sexual enhancement products.

    Product
    DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0773-2023·2023-05-10

    Chocolate Peanut Bites Recalled Due to Undeclared Milk Allergen

    Salento Organics is recalling Dark Chocolate Peanut Bites due to undeclared milk. Consumers with milk allergies should not consume this product.

    Product
    Salento Organics, Dark Chocolate Peanut Bites, Net WT. 4oz (113G)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0775-2023·2023-05-10

    Food Recall: Salento Organics Dark Chocolate Banana Bites Contain Undeclared Milk

    Salento Organics is recalling Dark Chocolate Banana Bites due to undeclared milk content, a major allergen. The recall affects multiple lot numbers distributed domestically and internationally.

    Product
    Salento Organics, Dark Chocolate Banana Bites, Net WT. 4oz (113G)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0777-2023·2023-05-10

    Dark Chocolate Pitaya Bites Recalled for Undeclared Milk

    Salento Organics Dark Chocolate Pitaya Bites are recalled for undeclared milk. The product poses a risk to consumers with milk allergies.

    Product
    Salento Organics, Dark Chocolate Pitaya Bites, Net WT. 4oz (113G)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0572-2023·2023-05-10

    NUX Male Enhancement Capsules Recalled for Undeclared Prescription Ingredients

    The FDA recalls NUX Male Enhancement capsules distributed nationwide because they contain undeclared sildenafil and tadalafil, making them an unapproved drug. Consumers should not use this product.

    Product
    NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0771-2023·2023-05-10

    Scarpetta Pink Pesto Pasta Sauce Recalled for Undeclared Pine Nuts

    Scarpetta brand Pink Pesto Pasta Sauce contains undeclared pine nuts. Consumers with tree nut allergies are at risk of allergic reactions.

    Product
    Scarpetta brand Pink Pesto Pasta Sauce; INGREDIENTS: Tomatoes (tomatoes, tomato juice, citric acid), Cream, Onions, Olive Oil, Basil, Garlic, Salt, Black Pepper, Citric Acid.; CONTAINS: MILK.; BC Gourmet USA, Inc., Lynn, MA;
    Category
    Food
    Distribution
    3 states