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.

8626–8650 of 29123

  • SevereFDA (Devices)·Z-1073-2021·2021-02-17

    Argon Medical Devices Recalls Transjugular Liver Biopsy Systems

    Argon Medical Devices is recalling 863 TLAB Transjugular Liver Biopsy Systems due to a manufacturing error that may cause the sheath to separate during use.

    Product
    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,
    Category
    Medical Device
    Distribution
    46 states
  • SevereNHTSA·21E014000·2021-02-17

    Cummins Recalls B6.7N Natural Gas Engines Due to Software Calibration Error

    Cummins is recalling certain Westport B6.7N natural gas engines because incorrect software calibration may prevent the engine from limiting speed or torque, potentially compromising safety functions like braking and stability control.

    Product
    ENGINE AND ENGINE COOLING:ENGINE:ENGINE CONTROL MODULE (ECU/ECM):SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1074-2021·2021-02-17

    Argon Medical Devices Recalls Transjugular Liver Biopsy System Due to Sheath Separation

    Argon Medical Devices is recalling the TLAB Transjugular Liver Biopsy System because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.

    Product
    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-0990-2021·2021-02-17

    Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals

    Aomori Olympus is recalling SD-240U-25 electrosurgical snares because inspection found some sterile packages have inadequate seals, posing an infection risk.

    Product
    SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0960-2021·2021-02-17

    Cook Medical Kwart Retro-Inject Ureteral Stent Set Recalled for Material Defect

    Cook Inc. is recalling 42 units of Kwart Retro-Inject Ureteral Stent Sets because they were manufactured with incorrect material, which may cause the stent to be stiffer and susceptible to degradation, breakage, or fragmentation.

    Product
    Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
    Category
    Medical Device
    Distribution
    6 states
  • SevereNHTSA·21E013000·2021-02-16

    Ford Recalls Air Bag Inflator Parts for Collision Repair

    Ford is recalling specific air bag inflator and module replacement parts used in collision repairs. These parts may explode due to propellant degradation, posing a risk of serious injury or death.

    Product
    MERCURY — MERCURY, FORD, LINCOLN MILAN, FUSION, MKZ, MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E012000·2021-02-16

    Reyco Granning Recalls Fire Truck Independent Front Suspensions

    Reyco Granning is recalling fire truck independent front suspensions because steering gear mounting bolts may loosen, potentially causing steering difficulties or loss of control.

    Product
    STEERING:CRITICAL FASTENERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V081000·2021-02-16

    Ford Recalls Vehicles Due to Air Bag Inflator Explosion Risk

    Ford is recalling specific 2004-2014 models because replacement air bag inflators may explode during deployment, potentially causing serious injury or death.

    Product
    FORD — FORD, MERCURY, LINCOLN RANGER, MUSTANG, FUSION, GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21T001000·2021-02-15

    Continental Recalls Tires Cured Too Long During Production

    Continental Tire is recalling certain Continental, General, and Barum brand tires cured too long during production. This defect may cause sudden air loss or tread loss, increasing crash risk.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V073000·2021-02-12

    2021-2022 Freightliner Cascadia trucks recalled for improper flywheel attachment

    Certain 2021-2022 Freightliner Cascadia vehicles equipped with Cummins X15 engines are being recalled due to improperly torqued capscrews on the flywheel. This could allow the flywheel to detach, causing loss of drive power and creating crash and injury risks.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21078·2021-02-12

    NZXT Recalls H1 Computer Cases Due to Fire Hazard

    NZXT is recalling H1 computer cases because metal screws can cause a short circuit and fire. Consumers should stop using the cases and contact NZXT for a free repair kit.

    Product
    NZXT H1 computer cases
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V069000·2021-02-12

    2021 Newmar Ventana motorhomes recalled for loose brake caliper bolts

    Newmar is recalling 2021 Ventana and Kountry Star motorhomes with incorrectly tightened brake caliper mounting bolts that could reduce brake effectiveness and increase crash risk.

    Product
    NEWMAR — NEWMAR KOUNTRY STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V066000·2021-02-11

    Trail King Recalls 2019-2021 Trailers Due to Brake Sealant Defect

    Trail King is recalling 2019-2021 trailers because missing sealant on the front axle brake extension tube may allow water intrusion, leading to corrosion or freezing of the brake caliper.

    Product
    TRAIL KING — TRAIL KING TKAHG, TKHG, TKMG, TKMB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0255-2021·2021-02-10

    Champlain Chocolate Company Recalls Dark Chocolate Containing Plastic Pieces

    Champlain Chocolate Company is recalling specific lots of Five Star Almond Dark Chocolate because the product may contain plastic pieces.

    Product
    Lake Champlain chocolates -FIVE STAR ALMOND Dark Chocolate 1.9oz - online stock code 1Y304-024008-1;UPC: 76993385800
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0270-2021·2021-02-10

    Dole Endless Summer Salad Kit Recalled for Undeclared Fish and Eggs

    Dole is recalling Endless Summer Salad Kits because some bags contain Caesar dressing with undeclared fish and eggs.

    Product
    Dole Endless Summer Salad Kit; 13 oz. bag UPC: 0-71430-01073-0 Contains Milk, Wheat Distributed by Dole Fresh Vegetables, Inc., Monterey, CA 93940 Contains Swiss cheese, Sunflower seeds, romaine lettuce, red cabbage, summer vinaigrette, herbs & spices, artisan croutons
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0946-2021·2021-02-10

    Medtronic HVAD Pump Implant Kits Recalled for Startup Failures

    Heartware, Inc. is recalling 19,562 Medtronic HVAD Pump Implant Kits because they may fail to start or restart at a higher rate than expected.

    Product
    Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0249-2021·2021-02-10

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling 7,071 bottles of Metformin Hydrochloride Extended-Release Tablets, 750 mg, because the product contains N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0925-2021·2021-02-10

    Hill-Rom Liko Multirall 200 Overhead Lifts Recalled for Detachment Risk

    Hill-Rom is recalling Liko Multirall 200 overhead lifts because a strap lock may not fully engage, causing the lift to detach from the rail and potentially drop the patient.

    Product
    Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabilitation. Affected devices: Liko Multirall 200 (product number 3130001) Universal SlingBar 450 R2R (product number 3156095) Universal Sling
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V062000·2021-02-10

    Certain 2019–2021 BMW Models Recalled for Brake System Defect

    BMW is recalling certain 2019–2021 models due to improper welding of the integrated brake system rotor and shaft, which could separate during hard braking and cause loss of braking assistance. Owners should contact BMW customer service at 1-800-525-7417 for a free replacement.

    Product
    BMW — BMW M850I, X5, 750LI, M760LI
    Category
    Vehicle
    Distribution
    Distributed nationwide