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.

4376–4400 of 29102

  • SevereFDA (Drugs)·D-1180-2023·2023-09-20

    WEFUN Capsules Recalled: Unapproved Drug with Undisclosed Sildenafil

    WEFUN Capsules 825 mg are being recalled due to contamination with sildenafil, an undisclosed active pharmaceutical ingredient not approved for the product. Distribution was nationwide.

    Product
    WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E068000·2023-09-18

    Hyundam Fuel Pump Recall for Potential Loss of Drive Power

    Hyundam Industrial is recalling fuel pumps where the impeller may deform, causing pump failure and loss of drive power, which increases the risk of a crash.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·044-2023·2023-09-15

    American Foods Group Recalls Ground Beef Due to E. Coli O103 Contamination

    American Foods Group is recalling approximately 58,281 pounds of ground beef products that may be contaminated with E. coli O103. The products were shipped to distributors in Georgia, Michigan, and Ohio.

    Product
    Green Bay Dressed Beef, LLC — American Foods Group, LLC Recalls Ground Beef Products Due to Possible E. Coli O103 Contamination
    Category
    Food
    Distribution
    3 states
  • SevereCPSC·23288·2023-09-14

    Generac Portable Generators Recalled for Fire and Burn Hazards

    Generac is recalling about 64,000 portable generators because the fuel tank can fail to vent properly, causing excess pressure and fuel expulsion that poses fire and burn hazards. Generac has received 27 incident reports, including three with severe burn injuries.

    Product
    Generac Portable Generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V635000·2023-09-14

    Gillig Recalls 2022-2023 Low Floor Buses Due to Driveshaft Fastener Issue

    Gillig is recalling 223 Low Floor transit buses from 2022-2023 because improperly tightened driveshaft fasteners could allow the driveshaft to detach, increasing crash risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V634000·2023-09-13

    2020 Kia Stinger: Fuel Pump Defect Causes Loss of Drive Power

    Kia is recalling 2018-2021 Stinger vehicles due to a fuel control valve defect that can cause loss of drive power and increased crash risk. Dealers will update engine software and replace the fuel pump as needed.

    Product
    KIA — KIA STINGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1169-2023·2023-09-13

    Digoxin Tablets Nationwide Recall: Bottles Mislabeled with Incorrect Dosages

    Marlex Pharmaceuticals recalls Digoxin Tablets nationwide due to a labeling error where bottles are mislabeled with incorrect dosages. Bottles labeled as 0.125mg contain 0.25mg and vice versa.

    Product
    Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·043-2023·2023-09-09

    Custom Made Meals Recalls Bacon-Wrapped Chicken Products Due to Undeclared Milk Allergen

    Custom Made Meals, LLC is recalling approximately 1,345 pounds of bacon-wrapped chicken products because they contain undeclared milk, a known allergen.

    Product
    Custom Made Meals, LLC — Custom Made Meals, LLC Recalls Bacon Wrapped Chicken Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V625000·2023-09-08

    2025 Ford E-350 Recalled for Transmission Park Pawl Defect

    Ford is recalling 2025 E-350 trucks and related models due to a transmission park pawl casting defect that may not fully engage, potentially causing vehicle rollaway.

    Product
    FORD — FORD E-350, F-750 SD, F-650 SD, F-650 INCOMPLETE CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V626000·2023-09-08

    Lincoln Aviator and Ford Explorer battery defect poses fire and power-loss risk

    Ford is recalling 2020-2022 Lincoln Aviators and Ford Explorers with 3.0L plug-in hybrid engines. A high-voltage battery manufacturing defect may cause battery failure, loss of drive power, and fire risk.

    Product
    FORD — FORD, LINCOLN EXPLORER, AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V624000·2023-09-07

    Midwest Fire Recalls 2022-2023 All-Poly Series Tanker-Pumper Fire Trucks

    Midwest Fire is recalling 2022-2023 All-Poly Series Tanker-Pumper fire trucks due to a software error that may cause a sudden loss of drive power, increasing the risk of a crash.

    Product
    MIDWEST FIRE — MIDWEST FIRE ALL-POLY SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·042-2023·2023-09-07

    USDA Recalls Frozen Pork Products Imported Without Reinspection

    Empacadora Frape, USA LLC is recalling approximately 20,455 pounds of frozen pork chicharron and carnitas that were imported without the required reinspection.

    Product
    Empacadora Frape, USA LLC, Recalls Pork Products Imported Without Benefit of Import Reinspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V623000·2023-09-07

    2023-2024 Alfa Romeo Tonale plug-in hybrid electric vehicles recalled for fire risk

    Chrysler is recalling 2023-2024 Alfa Romeo Tonale and Dodge Hornet plug-in hybrid electric vehicles. Improperly tightened battery and high voltage connector cables can overheat and cause fires while parked or driving.

    Product
    DODGE — DODGE, ALFA ROMEO HORNET, TONALE, TONALE PHEV
    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-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-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-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 (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-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
  • 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 (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-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 (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