The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

14026–14050 of 29192

  • SevereFDA (Devices)·Z-2397-2018·2018-07-18

    Stryker Recalls Specific Femoral Nail Due to Potential Breakage Risk

    Stryker GmbH is recalling specific femoral nails due to potential manufacturing defects that could cause the device to break prematurely.

    Product
    Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2417-2018·2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 8,890 EnTrust ICDs due to a potential loss of high voltage therapy near end-of-life. Patients should contact their healthcare provider.

    Product
    Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2406-2018·2018-07-18

    Stryker Recalls Femoral Nails Due to Potential Premature Breakage

    Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.

    Product
    Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2418-2018·2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 3 EnTrust ICDs because they may lose high voltage therapy near battery end-of-life without prior warning.

    Product
    Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2393-2018·2018-07-18

    Stryker Tibial Nail Recall Due to Potential Premature Breakage

    Stryker GmbH is recalling specific Tibial Nails because non-conforming cannulation may reduce strength and cause premature breakage.

    Product
    Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2420-2018·2018-07-18

    Medtronic EnTrust Escudo ICD Recall for Potential Loss of Therapy

    Medtronic is recalling EnTrust Escudo ICDs due to a potential loss of high voltage and anti-tachycardia pacing therapy as the battery nears its end of life.

    Product
    Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V475000·2018-07-18

    Forest River Recalls 2018-2019 Trailers Due to Wheel Bearing Defect

    Forest River is recalling 2018-2019 Rockwood and Flagstaff trailers because inner wheel bearings may seize, causing wheels to lock up and increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER ROCKWOOD, FLAGSTAFF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2405-2018·2018-07-18

    Stryker Recalls Femoral Nails Due to Potential Premature Breakage

    Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce component strength and lead to premature breakage.

    Product
    Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Food)·F-1615-2018·2018-07-18

    Hee Chang Dairy Black Bean Cereal Latte Recalled for Undeclared Allergens

    Hee Chang Dairy & Food Co., LTD is recalling Black Bean Cereal Latte because FDA inspection found undeclared allergens in the product.

    Product
    Black Bean Cereal Latte; 28.2 oz. package Ingredients: Non Dairy Creamer (corn syrup, vegetable oil, Sodium Caseinate, Silicon dioxide), Rice Powder, Bean Powder, Silicon dioxide, Refined Salt, Black Sesame. Corn syrup 57% Hydrogenated coconut oil 28% Sweet whey powder…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2395-2018·2018-07-18

    Stryker Recalls 17 Femoral Nails Due to Potential Premature Breakage

    Stryker GmbH is recalling 17 femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.

    Product
    Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2408-2018·2018-07-18

    Stryker Recalls Ankle Arthrodesis Nails Due to Potential Breakage Risk

    Stryker GmbH is recalling specific ankle arthrodesis nails because non-conforming cannulation may reduce strength and cause premature breakage.

    Product
    Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2401-2018·2018-07-18

    Stryker Recalls Specific Femoral Nail Products Due to Potential Breakage

    Stryker GmbH is recalling specific femoral nails due to potential manufacturing defects that could cause the device to break prematurely.

    Product
    Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Drugs)·D-1030-2018·2018-07-18

    AuroMedics Recalls Piperacillin and Tazobactam Injection Vials Due to Particulate Matter

    AuroMedics Pharma LLC is recalling 73,620 vials of Piperacillin and Tazobactam for Injection due to the presence of glass and silicone particulate matter.

    Product
    PIPERACILLIN AND TAZOBACTAM — PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0994-2018·2018-07-18

    Gaia Kratom Powder Recalled for Salmonella Contamination

    Gaia Ethnobotanical LLC is recalling specific lots of Gaia Kratom powder due to FDA-confirmed Salmonella contamination.

    Product
    Gaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2394-2018·2018-07-18

    Stryker Recalls Two Femoral Nails Due to Potential Premature Breakage

    Stryker GmbH is recalling two femoral nails that may have non-conforming cannulation, potentially leading to reduced strength and premature breakage.

    Product
    Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2419-2018·2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 8,821 EnTrust ICDs due to a potential loss of high voltage therapy near end-of-life. Patients should contact their healthcare provider.

    Product
    Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2404-2018·2018-07-18

    Stryker Recalls Femoral Nails Due to Potential Premature Breakage

    Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.

    Product
    Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2398-2018·2018-07-18

    Stryker Recalls Seven Femoral Nails Due to Potential Breakage Risk

    Stryker GmbH is recalling seven femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.

    Product
    Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Food)·F-1613-2018·2018-07-18

    Del Monte Vegetable Tray Recalled for Potential Cyclospora Contamination

    Del Monte is recalling 28 oz. vegetable trays with dip due to a potential link to a recent cluster of illnesses and possible Cyclospora contamination.

    Product
    Del Monte 28 oz. Small Veg Tray w/dip contains baby carrots, broccoli, cauliflower, celery sticks and dill dip
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1612-2018·2018-07-18

    Del Monte Vegetable Trays Recalled for Potential Cyclospora Contamination

    Del Monte is recalling 6 oz. and 12 oz. vegetable trays with dip due to a potential link to a recent cluster of illnesses and possible Cyclospora contamination.

    Product
    Del Monte 6 oz. Veg Tray w/dip; Del Monte 12 oz. Veg Tray w/dip contains baby carrots, broccoli, cauliflower and dill dip
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2380-2018·2018-07-18

    Intuitive Surgical Recalls da Vinci Xi Stapler Reloads Due to Missing Component

    Intuitive Surgical is recalling da Vinci Xi Stapler 45 Reloads because a missing knife mechanism component may prevent the device from cutting tissue.

    Product
    da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2400-2018·2018-07-18

    Stryker Recalls Femoral Nails Due to Potential Premature Breakage

    Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce component strength and lead to premature breakage.

    Product
    Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2407-2018·2018-07-18

    Stryker Recalls Ankle Arthrodesis Nails Due to Potential Breakage Risk

    Stryker GmbH is recalling specific ankle arthrodesis nails because non-conforming cannulation may reduce strength and cause premature breakage.

    Product
    Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2399-2018·2018-07-18

    Stryker Recalls Femoral Nails Due to Potential Premature Breakage

    Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.

    Product
    Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S
    Category
    Medical Device
    Distribution
    8 states
  • SevereNHTSA·18E055000·2018-07-17

    Martinrea Brake Hose Recall for Corrosion-Related Fluid Leak Risk

    Martinrea is recalling brake hose assemblies for Chrysler and Ford vehicles that may lack anti-corrosion plating, posing a risk of brake fluid leaks and reduced braking effectiveness.

    Product
    SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide