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.

13501–13525 of 29188

  • SevereFDA (Devices)·Z-3375-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 1,980 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TB19C CONT EPIDURAL TRAY, Material Number 332242 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1991-2018·2018-10-10

    Neighbors LLC Recalls Gluten-Free Cookie Dough for Undeclared Almonds

    Neighbors LLC is recalling 7,264 units of Crazy About Cookies Gluten Free Chocolate Chip Cookie Dough because the packaging fails to declare almonds as an ingredient.

    Product
    Crazy About Cookies***GLUTEN FREE CHOCOLATE CHIP COOKIE DOUGH**Net Wt. 2 lbs. (907.18g)**Nutrition facts***Ingredients: Whole grain sorghum flour, cane sugar, semi sweet chocolates**Contains eggs, milk and soy.***Manufactured in the same equipment that manufactures peanut…
    Category
    Food
    Distribution
    40 states
  • SevereNHTSA·18E095000·2018-10-10

    Alpha Technology Ignition Switch Recall Due to Engine Stall Risk

    Alpha Technology is recalling mechanical key ignition switches that may shift out of the RUN position, causing the engine to turn off and increasing crash risk.

    Product
    ELECTRICAL SYSTEM:IGNITION:SWITCH recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0064-2019·2018-10-10

    Leica HistoCore SPECTRA ST Slide Stainer Recalled for Electrical Safety Hazard

    Leica Microsystems is recalling 67 automated slide stainers because a single fault could expose users to hazardous mains voltage.

    Product
    Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V697000·2018-10-10

    Daimler Recalls 2018-2019 Freightliner Trucks for Engine Ground Stud Defect

    Daimler Trucks North America is recalling 2018-2019 Freightliner MT45G and MT55G vehicles because an improperly tightened engine ground stud may cause overheating and increase the risk of fire.

    Product
    FCCC — FCCC MT55G, MT45G
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0005-2019·2018-10-10

    Pfizer Recalls Elelyso Vials Due to Sterility Assurance Concerns

    Pfizer is recalling 12,416 vials of Elelyso (taliglucerase alfa) because loose metal ferrule crimps may compromise sterility.

    Product
    ELELYSO — ELELYSO (TALIGLUCERASE ALFA)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V703000·2018-10-05

    Daimler Trucks Recalls 2018-2019 Models for Loose Brake Caliper Bolts

    Daimler Trucks North America is recalling 2018-2019 Freightliner, Western Star, and FCCC trucks because brake caliper mounting bolts may be insufficiently tightened, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, FCCC, WESTERN STAR 114SD, XBS, XCM, XCP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V704000·2018-10-05

    Hyundai Recalls Ioniq Hybrids for Potential Fire Risk

    Hyundai is recalling 2017-2018 Ioniq Hybrid and 2018 Plug-In Hybrid vehicles because a faulty relay may overheat the rear seat, increasing the risk of a fire.

    Product
    HYUNDAI — HYUNDAI IONIQ HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V702000·2018-10-05

    Thomas Built Buses Recalls 2018-2019 Models Due to Brake Caliper Bolts

    Daimler Trucks North America is recalling 2018-2019 Thomas Built school buses because brake caliper mounting bolts may be insufficiently tightened, increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V685000·2018-10-04

    Toyota Recalls 2018-2019 Models for Air Bag Software Defect

    Toyota is recalling specific 2018-2019 Avalon, Sequoia, Tundra, and Avalon Hybrid vehicles because the air bag software may prevent deployment in a crash.

    Product
    TOYOTA — TOYOTA AVALON, SEQUOIA, TUNDRA, AVALON HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V694000·2018-10-04

    Suzuki Recalls 2017-2018 Motorcycles for Fuel Pump O-Ring Defect

    Suzuki is recalling 2017-2018 DL650, GSX-R1000, and GSX-S750 motorcycles because a twisted fuel pump O-ring may cause a fuel leak, increasing fire risk.

    Product
    SUZUKI — SUZUKI DL650, GSX-R1000, GSX-S750
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V684000·2018-10-04

    Toyota Recalls Prius and Prius V for Hybrid System Shutdown Risk

    Toyota is recalling 2010-2014 Prius and 2012-2014 Prius V vehicles because excessive voltage may cause the hybrid system to shut down, increasing crash risk.

    Product
    TOYOTA — TOYOTA PRIUS, PRIUS V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3268-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation

    Bausch & Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the body of the device.

    Product
    Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-3255-2018·2018-10-03

    Boston Scientific Recalls ESSENTIO Pacemakers Due to Battery Depletion

    Boston Scientific is recalling ESSENTIO pacemakers and CRT-P systems due to an elevated potential for early replacement caused by hydrogen-induced accelerated battery depletion.

    Product
    ESSENTIO Pacemaker
    Category
    Medical Device
    Distribution
    48 states
  • SevereFDA (Food)·F-1984-2018·2018-10-03

    Zakah Life Recalls Kratom Supplements Due to Salmonella Contamination Risk

    Zakah Life LLC is recalling Top Shelf White Maeng Da Premium Kratom supplements because the ingredient lacks safety assurance and red/green strains are potentially contaminated with Salmonella.

    Product
    Top Shelf White Maeng Da Premium Kratom, Zakah Life Dietary Supplement, Mitragyn Speciosa, packaged in 1) 90 capsules, 500 mg per capsules bottles, or 2) 3.52 oz // 100 grams of Kratom bags. Distributed by Zakah Life LLC Ankeny IA.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1972-2018·2018-10-03

    Men's Health Supplement Recalled for Undeclared Ingredients

    Confidence Inc. is recalling For-Men-10 dietary supplements because they contain undeclared ingredients, including HPMC and artificial colors.

    Product
    FP0392, For-Men-10, All Natural Formula to Overall Men's Health, A Dietary Supplement, 60 Tablets, UPC: 8 92483 00139 7
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1985-2018·2018-10-03

    Swanson Himalayan Crystal Salt Recalled for Metal Wire Contamination

    Swanson Health Products is recalling Himalayan Crystal Salt because it may contain metal wire pieces. The product was distributed nationwide and in Canada and Switzerland.

    Product
    Swanson Ultra, Himalayan Crystal Salt, #SWU403, Net Wt. 35.27 oz. (2.2 lbs) (1,000 grams). Product of Pakistan. Distributed by Swanson Health Products, Fargo, ND 58104.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V692000·2018-10-03

    MCI Recalls 2018-2019 J4500 Motorcoaches for Emergency Exit Window Defect

    Motor Coach Industries is recalling 2018-2019 MCI J4500 motorcoaches with 60-passenger seating due to insufficient emergency egress windows, which may delay passenger exit during an emergency.

    Product
    MCI — MCI J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1209-2018·2018-10-03

    Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defect

    Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.

    Product
    MINIVELLE — MINIVELLE (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3257-2018·2018-10-03

    Boston Scientific Recalls ACCOLADE Pacemakers Due to Battery Depletion Risk

    Boston Scientific is recalling specific ACCOLADE pacemakers and CRT-P systems due to an elevated potential for early replacement caused by hydrogen-induced accelerated battery depletion.

    Product
    ACCOLADE Pacemaker
    Category
    Medical Device
    Distribution
    48 states
  • SevereFDA (Devices)·Z-3261-2018·2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates

    Biomet UK Ltd. is recalling specific HipLOC hip fracture fixation system plates due to an undersized bore that prevents the lag screw from fitting.

    Product
    HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal…
    Category
    Medical Device
    Distribution
    Distributed nationwide