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.

14701–14725 of 29199

  • SevereNHTSA·18V169000·2018-03-12

    Ford Recalls Focus and Fusion Vehicles for Clutch Fracture Risk

    Ford is recalling 2013-2016 Focus and Fusion vehicles with manual transmissions because the clutch may fracture, causing transmission damage and fluid leaks that could lead to fire.

    Product
    FORD — FORD FOCUS, FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V163000·2018-03-12

    Freightliner Custom Chassis Recalls 2011-2017 RV Chassis for Fire Risk

    Daimler Trucks North America is recalling 9,480 Freightliner Custom Chassis vehicles due to a power steering hose defect that may cause electrical arcing and fire.

    Product
    FCCC — FCCC XBR, XCM, XCL, XCR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V167000·2018-03-12

    Ford Recalls 2014-2018 Fusion and Lincoln MKZ for Steering Wheel Defect

    Ford is recalling 2014-2018 Fusion and Lincoln MKZ vehicles because the steering wheel bolt may loosen, allowing the wheel to detach and causing loss of control.

    Product
    LINCOLN — LINCOLN, FORD MKZ, FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E015000·2018-03-09

    SynTec Recalls S3B School Bus Seats Due to Bracket Crack Risk

    SynTec Seating Solutions is recalling S3B Non-Restraint Wall Mounted Seats because the mounting bracket may crack, increasing injury risk in a crash.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V160000·2018-03-08

    Dodge Ram 1500 Fuel Tank Strap Corrosion Recall

    Chrysler is recalling 2009-2012 Dodge Ram 1500 trucks in 21 states and D.C. because a fuel tank bracket may corrode, causing the tank to drop and leak fuel.

    Product
    DODGE — DODGE, RAM RAM 1500, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V159000·2018-03-08

    Volkswagen Recalls 2018 Tiguan Models Due to Engine Support Bolt Issue

    Volkswagen is recalling 2018 Tiguan long wheel base vehicles because engine support bolts may not be properly tightened, which could lead to engine breakdown or loss of power.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0738-2018·2018-03-07

    Ventana Hematoxylin II and HRP Dispensers Recalled for Leaking and Sticking

    Ventana Medical Systems is recalling Hematoxylin II and specific HRP dispensers due to increased reports of leaking and sticking.

    Product
    Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0775-2018·2018-03-07

    Zimmer Biomet Recalls 337 Femoral Intramedullary Nail Loaner Kits

    Zimmer Biomet is recalling 337 femoral intramedullary nail loaner kits because the bolt connecting the insertion guide to the nail can fracture during insertion.

    Product
    979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1171-2018·2018-03-07

    Circulatory Technology Recalls Cardiopulmonary Bypass Blood Reservoirs

    Circulatory Technology Inc is recalling specific models of cardiopulmonary bypass blood reservoirs because they may collapse during use, potentially causing a drop in circuit blood flow.

    Product
    **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
    Category
    Medical Device
    Distribution
    20 states
  • SevereNHTSA·18V155000·2018-03-07

    New Flyer Recalls Transit Buses Due to Drive Shaft End-Cap Failure Risk

    New Flyer is recalling 2016-2018 XDE40, XDE60, and 2017 XDE35 buses because plastic drive shaft end-caps may crack, causing loss of drive power and increasing crash risk.

    Product
    NEW FLYER — NEW FLYER XDE40, XDE60, XDE35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E012000·2018-03-07

    S&B Filters Recalls Cold Air Intake Kits for Ford Trucks

    S&B Filters is recalling specific Cold Air Intake Kits for Ford Super Duty trucks because a missing hole in the battery tray may prevent proper grounding, increasing fire risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0547-2018·2018-03-07

    Fagron Recalls SyrSpend SF Suspending Base Due to Microbial Contamination

    Fagron, Inc. is recalling SyrSpend SF Suspending Base because the product was found to be contaminated with yeast and mold.

    Product
    SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0732-2018·2018-03-07

    Ventana ultraView SISH Detection Kit Recalled for Leaking Reagent Dispensers

    Ventana Medical Systems is recalling 6 units of the ultraView SISH Detection Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0774-2018·2018-03-07

    Zimmer Biomet Recalls Antegrade Femoral Nail Instrument Kits

    Zimmer Biomet is recalling 337 Antegrade Femoral Nail Instrument Kits because a bolt may fracture during use, potentially affecting patients undergoing orthopedic surgery.

    Product
    14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0740-2018·2018-03-07

    Ventana Medical Systems Recalls NEXES VEN IVIEW DAB DET KT JPN-US EXPORT

    Ventana Medical Systems is recalling NEXES VEN IVIEW DAB DET KT JPN-US EXPORT in vitro diagnostic kits due to increased reports of leaking and sticking reagent dispensers.

    Product
    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E013000·2018-03-07

    Norcold Recalls RV Refrigerators Due to Propane Leak Risk

    Norcold is recalling specific RV refrigerators because loose gas valve screws may allow propane to leak into the passenger compartment, creating a fire risk.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0719-2018·2018-03-07

    Medistim Veriq System Recalled Due to Component Overheating and Smoke Emission

    Medistim Asa is recalling two Medistim Veriq System units because a component overheated, causing connector melting and smoke emission.

    Product
    MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0817-2018·2018-03-07

    Circulatory Technology Recalls Better-Bladder ECMO Blood Reservoirs

    Circulatory Technology Inc is recalling Better-Bladder cardiopulmonary bypass blood reservoirs because they may collapse during use, potentially causing a drop in circuit blood flow.

    Product
    Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
    Category
    Medical Device
    Distribution
    20 states
  • SevereNHTSA·18V156000·2018-03-07

    Nissan Recalls 2011-2012 Juke Vehicles for Fuel Leak Risk

    Nissan is recalling 2011-2012 Juke vehicles because a previous repair may have left the fuel pressure sensor loose, creating a potential fire hazard.

    Product
    NISSAN — NISSAN JUKE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0544-2018·2018-03-07

    Acyclovir Tablets Recalled Due to Presence of Torsemide Tablets

    Apace KY LLC is recalling 630 cartons of Acyclovir 400 mg tablets because some blister cavities may contain Torsemide tablets instead.

    Product
    ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0549-2018·2018-03-07

    B. Braun Recalls Sodium Chloride Irrigation Due to Particulate Matter

    B. Braun Medical Inc. is recalling 17,360 units of 0.9% Sodium Chloride Irrigation USP due to the presence of polyethylene particulate matter.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0734-2018·2018-03-07

    Ventana Recalls CINtec PLUS Cytology Kit Due to Leaking Reagent Dispensers

    Ventana Medical Systems is recalling 748 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0713-2018·2018-03-07

    Siemens SOMATOM Go.Up CT Table Recall for Potential Instability

    Siemens Medical Solutions is recalling six SOMATOM Go.Up CT system tables because improperly tightened bolts may loosen, causing the table to become unstable.

    Product
    SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0715-2018·2018-03-07

    Mobius AIRO Mobile CT System Recalled for Unintended Motion Risk

    Mobius Imaging is recalling 105 AIRO Mobile CT Systems due to a risk of unintended device motion during startup or scan preparation.

    Product
    AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
    Category
    Medical Device
    Distribution
    Distributed nationwide