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.

15426–15450 of 29205

  • SevereFDA (Devices)·Z-3193-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because a raw material anomaly may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·106-2017·2017-10-04

    Thompson's Ground Beef Recalled for Possible E. coli O157:H7 Contamination

    Clair D. Thompson & Sons, Inc. is recalling approximately 700 pounds of ground beef products due to possible E. coli O157:H7 contamination.

    Product
    Clair D. Thompson & Sons, Inc. Recalls Ground Beef Products Due To Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·17V616000·2017-10-03

    Braun Recalls 2016 BraunAbility MXV Vehicles Due to Airbag Sensor Defect

    Braun is recalling 2016 BraunAbility MXV wheelchair accessible vehicles because a seat position sensor may dislodge, potentially causing the frontal airbag to deploy with improper force.

    Product
    BRAUN — BRAUN BRAUNABILITY MXV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V615000·2017-10-03

    Great Dane Recalls 2018 Everest Trailers Due to Brake Caliper Bolt Issue

    Great Dane is recalling 2018 Everest trailers because brake caliper bolts may not be properly torqued, which could cause the caliper to detach and result in a loss of braking ability.

    Product
    GREAT DANE — GREAT DANE EVEREST SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V614000·2017-10-02

    Trail King Recalls 2018 Fifth-Wheel Trailers Due to Brake Caliper Bolt Issue

    Trail King is recalling 2018 Fifth Wheel Live Bottom trailers because improperly torqued brake caliper bolts may allow the caliper to detach, increasing crash risk.

    Product
    TRAIL KING — TRAIL KING FIFTH-WHEEL LIVE BOTTOM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17E055000·2017-10-02

    IMMI Recalls School Bus Seats Due to Fracturing Buckle Mount Rods

    Indiana Mills and Manufacturing is recalling Generation IV school bus seats because the buckle mount rods may fracture, increasing injury risk in crashes.

    Product
    SEAT BELTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17T016000·2017-09-29

    Max-Trac Recalls Avon Viper Stryke Tires for Tread Separation Risk

    Max-Trac is recalling specific Avon Viper Stryke tires because a tread bulge or separation could cause loss of vehicle control and increase crash risk.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V608000·2017-09-29

    Kia Recalls 2014-2016 Soul Models Due to Steering Gear Separation Risk

    Kia is recalling 2014-2016 Soul and Soul EV vehicles because a pinion plug defect may allow the pinion gear to separate, potentially causing loss of steering and increasing crash risk.

    Product
    KIA — KIA SOUL, SOUL EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V609000·2017-09-29

    Mitsubishi Recalls Outlander and Lancer Models for Defective Starter Relays

    Mitsubishi is recalling 2015-2017 Outlander, Outlander Sport, Lancer, and Lancer Evolution vehicles because defective relays may cause engine stalls, reduced power, or overheating.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT, OUTLANDER, LANCER, LANCER EVOLUTION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V606000·2017-09-28

    Silver Eagle Vast-20W Trailer Brake Caliper Bolt Recall

    Silver Eagle is recalling 2018 Vast-20W converter dolly trailers because brake caliper bolts may not be properly torqued, risking caliper detachment and loss of braking ability.

    Product
    SILVER EAGLE — SILVER EAGLE VAST-20W
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3143-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage

    Medtronic Navigation is recalling Spine Referencing Instrumentation sets due to a risk that clamps may break during use, potentially leaving components in the patient's body.

    Product
    Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for…
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Food)·F-3559-2017·2017-09-27

    Dierbergs Cabernet Grille Butter Recalled for Undeclared Wheat and Soy

    Dierbergs Markets is recalling Cabernet Grille Butter because it contains undeclared wheat and soy allergens.

    Product
    Cabernet Grille Butter, Net Wt. 3 OZ, packaged in clear plastic tubs. Dierbergs Kitchens
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-3141-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Damage

    Medtronic Navigation is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall units due to a risk of component breakage or damage during use.

    Product
    Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the…
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-3139-2017·2017-09-27

    Medtronic Spine Referencing Clamp Recall for Potential Breakage

    Medtronic is recalling Spine Referencing Instrumentation clamps due to a risk of breakage that could leave components in the patient's body.

    Product
    Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the…
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-3140-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Damage

    Medtronic is recalling Spine Referencing Instrumentation because the clamps may be damaged if opened beyond limits, potentially leaving components in the patient.

    Product
    Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the…
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Drugs)·D-1168-2017·2017-09-27

    Pfizer Recalls Levophed Injection Due to Sterility Assurance Concerns

    Pfizer is recalling specific lots of Levophed (norepinephrine bitartrate) injection because a damaged sterilizing filter may have compromised sterility.

    Product
    LEVOPHED — LEVOPHED (NOREPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3142-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage

    Medtronic is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Short units because they may break during use, potentially leaving components in the patient's body.

    Product
    Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of…
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Food)·F-3555-2017·2017-09-27

    Kelejete Dark Chocolate Energy Bar Recalled for Allergen Mislabeling

    Kelejete LLC is recalling Dark Chocolate Jete Nutritional Energy Bars because the label failed to declare peanuts and pecans in the 'Contains' statement.

    Product
    Dark Chocolate Jete Nutritional Energy Bar, One Mother of a Bar, Net wt. 61 gram. Product is package in a cellophane sealed wrapper. UPC 6 16320 77469 1. The label is read in parts: ***Dark Chocolate***Jete Nutritional Energy Bar***Contains Nuts***INGREDIENTS: Peanut Butter…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1167-2017·2017-09-27

    Pfizer Recalls Hydromorphone Hydrochloride Injection Due to Sterility Assurance Concerns

    Pfizer is recalling 115,370 vials of Hydromorphone Hydrochloride Injection because a damaged sterilizing filter may have compromised sterility assurance during manufacturing.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1175-2017·2017-09-27

    Genentech Recalls Activase Due to Cracked Sterile Water Vials

    Genentech is recalling 16,882 units of Activase (alteplase) because the included sterile water vials may have cracked or chipped glass.

    Product
    Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V604000·2017-09-27

    Polar Tank SRJ7 Trailer Recall for Brake Caliper Bolt Torque Issues

    Polar Tank is recalling 2018 SRJ7 trailers because brake caliper bolts may not be properly torqued, risking caliper detachment and loss of braking ability.

    Product
    POLAR TANK — POLAR TANK SRJ7 TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide