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.

4976–5000 of 29102

  • SevereFDA (Devices)·Z-1797-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Reduced Energy Output

    Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a manufacturing issue. The recall affects 1,354 units distributed in the United States and internationally.

    Product
    ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1813-2023·2023-06-28

    Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect

    Medtronic implantable defibrillators may fail to deliver therapy during critical cardiac events due to a feedthrough defect. Approximately 25,058 units are affected nationwide and worldwide.

    Product
    ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1766-2023·2023-06-28

    Implantable defibrillators may deliver reduced or no energy during therapy

    Medtronic implantable defibrillators and cardiac resynchronization devices with a specific glassed feedthrough may fail to deliver full energy during therapy. Approximately 8,575 units affected worldwide.

    Product
    CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1767-2023·2023-06-28

    Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect

    Certain Medtronic implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a specific feedthrough defect. The 4,767 affected units were distributed nationwide and worldwide.

    Product
    CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1805-2023·2023-06-28

    Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output

    Medtronic ICDs and CRT-Ds with a specific feedthrough defect may produce reduced or no energy output during high-voltage therapy. The recall involves approximately 4,546 units distributed nationwide and worldwide.

    Product
    ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1734-2023·2023-06-28

    Medtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output

    Medtronic is recalling 14 units of CRTD VIVA QUAD XT implantable cardioverter defibrillators due to rare potential for reduced or no energy output during high voltage therapy. Affected devices were manufactured with a specific feedthrough defect.

    Product
    CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1807-2023·2023-06-28

    Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy

    Medtronic recalls approximately 5,622 implantable cardioverter defibrillators that may produce reduced or no energy output during high-voltage therapy due to a specific feedthrough component defect.

    Product
    ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V453000·2023-06-28

    Freightliner eCascadia Recalled for Electronic Stability Control Software Defect

    Daimler Trucks North America is recalling 2023-2024 Freightliner eCascadia vehicles because the service brake system may incorrectly calculate vehicle mass, impairing electronic stability control performance.

    Product
    FREIGHTLINER — FREIGHTLINER E-CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V443000·2023-06-26

    Porsche Recalls Macan and Panamera Models for Seat Belt Anchor Defect

    Porsche is recalling certain 2016-2020 Macan and Panamera models because a rear seat belt anchor screw may not be tightened properly, increasing injury risk in a crash.

    Product
    PORSCHE — PORSCHE MACAN S, MACAN, MACAN TURBO, PANAMERA TURBO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V438000·2023-06-22

    Altec Recalls 2019-2022 Aerial Devices for Electrical Safety Defect

    Altec is recalling 2019-2022 AT335 aerial devices because an inverter-powered outlet may lack ground-fault protection, increasing the risk of injury or fire.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E046000·2023-06-22

    Lippert Recalls 5200 and 6000 CURT RV Axles Due to Grease Fitting Defect

    Lippert is recalling 5200 and 6000 CURT RV axles because improperly tightened grease fittings may separate, potentially causing wheel detachment and increasing crash risk.

    Product
    SUSPENSION:MULTIPLE AXLE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23229·2023-06-22

    Zuru Recalls 7.5 Million Baby Shark Bath Toys for Impalement Risk

    Zuru is recalling about 7.5 million Robo Alive Junior Baby Shark bath toys due to hard plastic top fins that pose risks of impalement, laceration, and puncture injuries to children. Twelve reported injuries have been documented, including nine cases requiring stitches or medical attention.

    Product
    Robo Alive Junior Baby Shark Sing & Swim Bath Toys (full-size) and Robo Alive Junior Mini Baby Shark Swimming Bath Toys (mini-size)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·23231·2023-06-22

    Research Products Steam Humidifiers Recalled for Fire Hazard

    Research Products is recalling about 36,200 steam humidifiers with faulty electrode connector wires that can loosen, cause arcing, and overheat. The company has received 103 reports of overheating, including 10 residential fires causing over $10 million in damage.

    Product
    Steam Humidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0874-2023·2023-06-21

    Hand sanitizer recalled nationwide for methanol contamination

    SOFT HANDS Alcohol Antiseptic 80% hand sanitizer is recalled nationwide due to FDA detection of methanol contamination. Approximately 7,303 gallons were distributed with manufacture dates from March to August 2020.

    Product
    SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon / 3785.41ml, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0873-2023·2023-06-21

    Hand Sanitizer Containing Methanol Recalled Due to Chemical Contamination

    Jarman's Midwest Cleaning Systems recalled 2,365 gallons of 80% alcohol antiseptic hand sanitizer nationwide due to FDA-detected methanol contamination. Consumers should stop using affected products immediately.

    Product
    Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1667-2023·2023-06-21

    Nitric Oxide Delivery System check valve misalignment risk

    NOxBOXi Nitric Oxide Delivery System devices may malfunction due to misaligned check valves, risking gas leaks and therapy interruption. This could lead to oxygen desaturation if the device fails during patient use.

    Product
    NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0985-2023·2023-06-21

    Van Leeuwen ice cream recalled for undeclared walnuts

    Van Leeuwen brand ice cream may contain undeclared walnuts. Consumers with walnut allergies should not consume this product.

    Product
    Van Leeuwen brand BROWN SUGAR CHUNK WITH COOKIE DOUGH & BROWNIES FENCH ICE CREAM; 14 FL OZ (414 ML); ingredients: cream, milk, dark brown sugar, cane sugar, egg yolks, wheat flour, unbleached flour (wheat flour, malted barley flour), water, cocoa processed with alkali, canola oil
    Category
    Food
    Distribution
    10 states
  • SevereUSDA FSIS·026-2023·2023-06-20

    BCI Foods Recalls Chicken Noodle Soup for Import Violation

    BCI Foods Inc. is recalling approximately 13,561 pounds of chicken noodle soup products that were not presented for FSIS import reinspection.

    Product
    BCI Foods Inc. Recalls Chicken Noodle Soup Products Produced Without Benefit of Import Reinspection
    Category
    Food
    Distribution
    4 states
  • SevereUSDA FSIS·025-2023·2023-06-20

    USDA Recalls Ineligible Imported Ready-to-Eat Pork Rind Product

    Distribuidora El Paisano Import is recalling 1,715 pounds of TorTrix Con Chicharrón pork rinds imported from Guatemala, a country ineligible to export meat to the U.S.

    Product
    Distribuidora El Paisano Import, LLC, Recalls Ineligible Ready-To-Eat Pork Rind Product Imported from Guatemala
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·23V433000·2023-06-16

    Altec Recalls L and LR Series Aerial Devices for Hydraulic Hose Defect

    Altec is recalling 1999-2022 L and LR Series aerial devices because a hydraulic hose may fail, causing the platform or load to move unexpectedly.

    Product
    ALTEC — ALTEC LR SERIES AERIAL DEVICE, L SERIES AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide