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.

1876–1900 of 4878

  • SevereNHTSA·22V797000·2023-09-10

    Autocar Xpeditor Steering Column Pinch Bolt Defect Recall

    Autocar is recalling 2021-2023 Xpeditor vehicles because the steering column shaft pinch bolt may be improperly secured and bind, causing sudden loss of steering and increasing crash risk.

    Product
    AUTOCAR — 2021 AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V523000·2023-09-07

    2022 and 2023 Land Rover Defender seat belt pretensioner defect recall

    Jaguar Land Rover is recalling certain 2022-2023 Land Rover Defender and other models due to defective front seat belt pretensioners that may fail to properly restrain occupants in a crash, increasing injury risk.

    Product
    LAND ROVER — 2022 LAND ROVER DEFENDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2467-2023·2023-09-06

    EVIS EXERA III Duodenovideoscope Recalled Due to Patient Infection Reports

    Olympus Corporation recalls 6,426 units of the EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to recent reports of patient infections. The device was distributed nationwide in the United States.

    Product
    EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2431-2023·2023-09-06

    Cardiosave Hybrid Intra-Aortic Balloon Pump charging issue recall

    The Cardiosave Hybrid Intra-Aortic Balloon Pump console fails to charge if not fully inserted into the hospital cart. Users unaware of this requirement may attempt to use a non-charged device during critical cardiac care.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2433-2023·2023-09-06

    Cardiosave Hybrid IABP devices recalled for temperature and pumping function failures

    Datascope is recalling Cardiosave Hybrid intra-aortic balloon pumps due to reported temperature alarms that can cause loss of pumping function or unexpected standby mode. Users have reported these system failures in critical cardiac support devices.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1150-2023·2023-09-06

    Vegetal Vigra Capsules Recalled for Containing Unapproved Sildenafil

    The FDA is recalling Vegetal Vigra 200mg capsules nationwide because they contain sildenafil, an active ingredient in FDA-approved medications. The product was marketed without FDA approval.

    Product
    Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2436-2023·2023-09-06

    Cardiosave Rescue IABP Alarms May Trigger Unexpectedly During Therapy

    Datascope Corp. is recalling approximately 9,175 Cardiosave Rescue IABPs because unexpected gas-loss and gas-gain alarms may occur during therapy due to patient movement, blood in the circuit, and hardware issues.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2438-2023·2023-09-06

    Cardiosave Rescue Intra-Aortic Balloon Pumps Recalled Due to Autofill Failure

    Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps due to autofill failures that can cause the pump to stop.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2432-2023·2023-09-06

    Cardiosave Rescue Intra-Aortic Balloon Pumps Fail to Charge When Improperly Inserted

    Datascope Corp. is recalling 9,175 units of Cardiosave Rescue IABP devices because batteries will not charge if the console is not fully inserted into the hospital cart. Users were often unaware of this insertion requirement.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2437-2023·2023-09-06

    Cardiosave Hybrid Intra-Aortic Balloon Pumps recalled for autofill failure

    Datascope Corp. is recalling Cardiosave Hybrid intra-aortic balloon pumps due to autofill failure causing pump stops. The FDA Class I recall affects approximately 9,175 units distributed nationwide.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1476-2023·2023-09-06

    Stonewall Kitchen Peanut Butter Maltballs Recalled for Undeclared Allergens

    Stonewall Kitchen brand Peanut Butter Maltballs (6oz) may contain undeclared peanut, soy, and wheat. Consumers with allergies to these ingredients should not consume this product.

    Product
    Stonewall Kitchen brand Peanut Butter Maltballs packaged in 6oz clear plastic packaging
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2435-2023·2023-09-06

    Intra-Aortic Balloon Pumps recalled for unexpected gas loss and gain alarms

    Datascope's Cardiosave Hybrid Intra-Aortic Balloon Pumps may trigger unexpected alarms indicating gas loss or gain due to undocumented causes including patient movement and blood in the circuit. The FDA Class I recall affects 9,175 units.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2434-2023·2023-09-06

    Cardiosave Rescue IABP Pumps Recalled for System Overheating and Pump Failure

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to system overheating alarms that can cause loss of pumping function and device shutdown.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·23269·2023-08-31

    Frigidaire Gas Cooktops Recalled for Gas Leak and Fire Hazard

    Electrolux Group is recalling about 215 Frigidaire gas cooktops because plastic control knobs with black shafts can crack or break during use, creating a risk of gas leak and fire. Electrolux has received 63 reports of cracking or breaking, including one minor injury from a gas leak and one report of fire.

    Product
    Frigidaire Stainless-Steel 30-inch 4 Burner and 36-inch 5 Burner Gas Cooktops
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·23788·2023-08-31

    Polaris MATRYX PRO RMK and MATRYX RMK KHAOS Snowmobiles Recalled for Puncture Hazard

    Polaris is recalling about 15,900 Model Year 2022–2023 MATRYX PRO RMK and MATRYX RMK KHAOS snowmobiles because handlebar hooks pose a puncture hazard and risk of serious injury during crashes. The firm has received four reports of puncture wounds.

    Product
    Polaris Snowmobiles, Model Year 2022-2023 MATRYX PRO RMK and MATRYX RMK KHAOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1478-2023·2023-08-30

    Soft Serve on the Go Peanut Butter ice cream recalled for Listeria contamination

    Real Kosher Ice Cream recalls Soft Serve on the Go Peanut Butter ice cream due to potential Listeria contamination. Consumers should discard the product or return it.

    Product
    Soft Serve on the Go brand Razzle n' Dazzle Peanut Butter flavor; 8 fl oz; UPC 0-91404-15133-7
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-2248-2023·2023-08-30

    Carina Sub-Acute Care Ventilator Recalled for Toxic Chemical Emission

    Draeger Medical is recalling 11,621 Carina Sub-Acute Care Ventilators because polyurethane components emit 1,3-Dichloropropan-2-ol at levels exceeding safe limits during extended use in pediatric patients.

    Product
    Carina Sub-Acute Care Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1451-2023·2023-08-30

    Team Fresh & Go Mixed Fruit Cup Recalled Due to Potential Listeria Contamination

    Freshy Foods, LLC is recalling Team Fresh & Go Mixed Fruit Cup due to potential Listeria monocytogenes contamination in 249 units distributed to facilities in Florida, Louisiana, and Mississippi.

    Product
    Team Fresh & Go: Mixed Fruit Cup, packaged in 16oz plastic cup with lid. Packaged and sold as single unit.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1452-2023·2023-08-30

    Pineapple Cup Recall Due to Listeria Contamination Risk

    Freshy Foods, LLC is recalling Team Fresh & Go Pineapple Cups due to potential Listeria monocytogenes contamination. The recall affects 214 units distributed in Florida, Louisiana, and Mississippi.

    Product
    Team Fresh & Go: Pineapple Cup, packaged in 12oz plastic cup with lid. Packaged and sold as single unit.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1477-2023·2023-08-30

    Soft Serve on the Go Vanilla Chocolate Ice Cream Recalled for Listeria

    Real Kosher Ice Cream, Inc. is recalling Soft Serve on the Go brand Vanilla Chocolate ice cream due to potential Listeria monocytogenes contamination. The product was distributed across multiple U.S. states and several countries.

    Product
    Soft Serve on the Go brand Vanilla Chocolate flavor; 8 fl oz; UPC 0-91404-15129-0 Soft Serve on the Go brand Parve Vanilla Chocolate flavor; 8 fl oz; UPC 0-91404-15113-9
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1480-2023·2023-08-30

    Soft Serve on the Go Strawberry Mango Sorbet Recalled for Listeria Contamination Risk

    Real Kosher Ice Cream, Inc. is recalling Soft Serve on the Go brand Strawberry Mango Sorbet due to potential Listeria monocytogenes contamination. The product was distributed across multiple U.S. states and international locations.

    Product
    Soft Serve on the Go brand Sorbet Strawberry Mango Sorbet flavor; 8 fl oz; UPC 0-91404-15128-3
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1481-2023·2023-08-30

    Soft Zero on the Go Lite Peanut Butter Ice Cream Recalled for Listeria

    Soft Zero on the Go brand Lite Peanut Butter ice cream is being recalled due to potential Listeria monocytogenes contamination. The affected product was distributed across multiple U.S. states and internationally.

    Product
    Soft Zero on the Go brand Lite Peanut Butter flavor; 8 fl oz; UPC 0-91404-15285-3
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1450-2023·2023-08-30

    Freshy Foods Recalls Team Fresh & Go Cantaloupe Cups for Listeria Risk

    Freshy Foods is recalling Team Fresh & Go Cantaloupe Cups due to potential Listeria monocytogenes contamination. The affected product was distributed in Florida, Louisiana, and Mississippi.

    Product
    Team Fresh & Go: Cantaloupe Cup, packaged in 12oz plastic cup with lid. Packaged and sold as single unit.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1479-2023·2023-08-30

    Soft Serve on the Go Ice Cream Recalled Due to Listeria Contamination

    Real Kosher Ice Cream's Soft Serve on the Go Caramel Vanilla ice cream (8 fl oz) may be contaminated with Listeria monocytogenes. The product was distributed across multiple US states and internationally.

    Product
    Soft Serve on the Go brand Caramel Vanilla flavor; 8 fl oz; UPC 0-91404-15131-3
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-2389-2023·2023-08-23

    MAHURKAR Dialysis Catheter Recalled for Center Lumen Obstruction Risk

    Covidien LP recalled 15,209 MAHURKAR dialysis catheters due to excessive lubricant in the center lumen, which may cause catheter occlusion, reduce blood flow, or lead to hemolysis and blood clots.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP
    Category
    Medical Device
    Distribution
    Distributed nationwide