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.

14226–14250 of 29192

  • SevereFDA (Devices)·Z-2039-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.

    Product
    LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: a. Product Code LXMC-13; b. Product Code LXMC-14; c. Product Code LXMC-15; d. Product Code LXMC-16; e. Product Code LXMC-17; Laparoscopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V375000·2018-06-06

    Volkswagen Recalls 2018 Atlas and Tiguan for Passenger Air Bag Defect

    Volkswagen is recalling 2018 Atlas and Tiguan vehicles because the passenger frontal air bag may tear or fail to unfold properly in a crash, increasing injury risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2035-2018·2018-06-06

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Charging Failure

    Philips is recalling five HeartStart MRx monitor/defibrillators because a faulty circuit board may prevent charging, potentially delaying life-saving therapy.

    Product
    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2048-2018·2018-06-06

    Ethicon HARMONIC ACE Shears Recalled for Inadvertent Activation Risk

    Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears because an internal component may cause continuous or inadvertent activation of the device.

    Product
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2041-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.

    Product
    LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1952-2018·2018-06-06

    Gyrus ACMI Reusable Active Cord Recalled for Fire Hazard

    Gyrus Acmi is recalling 6,447 reusable active cords for electrosurgical generators due to a potential risk of sparking and causing a fire.

    Product
    Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2038-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device discontinuous or open.

    Product
    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-17…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·045-2018·2018-06-04

    Goodman Recalls Fully Cooked Ground Beef Due to Plastic Contamination

    Goodman Food Products is recalling approximately 34,400 pounds of fully cooked ground beef products due to possible contamination with hard, white plastic.

    Product
    Goodman Food Products, Texas Inc. — Goodman Food Products Recalls Fully Cooked Ground Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·18V361000·2018-06-01

    Forest River Recalls 2019 Wildcat Trailers Due to Underrated Tires

    Forest River is recalling 2019 Wildcat recreational trailers because they were equipped with underrated tires, which could lead to tire failure and increase the risk of a crash.

    Product
    FOREST RIVER — FOREST RIVER WILDCAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V357000·2018-06-01

    2019 Forest River and Coachmen Motorhomes Recalled for Rear Axle Defect

    Forest River is recalling 2019 Forester, Sunseeker, and Coachmen Leprechaun and Freelander motorhomes because rear axle U-Bolts may loosen, increasing crash risk.

    Product
    COACHMEN — COACHMEN, FOREST RIVER LEPRECHAUN, SUNSEEKER, FORESTER, FREELANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V366000·2018-06-01

    Forest River Recalls Transit Buses Due to Rear Axle U-Bolt Defect

    Forest River is recalling certain 2018-2019 transit buses because insufficiently tightened rear axle U-bolts may break, causing the axle to separate and increasing crash risk.

    Product
    STARCRAFT BUS — STARCRAFT BUS, FOREST RIVER, ELKHART SENATOR II MVP, ALLSTAR MVP, SENATOR II, ROCKPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V369000·2018-06-01

    Volkswagen and Audi Recall 2018 Models for Brake Caliper Coating Defect

    Volkswagen and Audi are recalling 2018 models because brake caliper pistons may have insufficient coating, potentially reducing braking performance and increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI PASSAT, GTI, GOLF, SQ5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V364000·2018-06-01

    Jayco Recalls 2018-2019 Fifth-Wheel Trailers Due to Propane Strap Defect

    Jayco is recalling 2018-2019 fifth-wheel trailers because the propane tank strap may separate, increasing the risk of a crash or fire.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL, JAYCO TRAVEL TRAILER, JAYCO NORTH POINT, PINNACLE, SEISMIC, EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V363000·2018-06-01

    Kia Recalls 507,587 Vehicles Due to Air Bag Control Unit Short Circuit Risk

    Kia is recalling 507,587 vehicles because the air bag control unit may short circuit, preventing frontal air bags and seat belt pretensioners from deploying in a crash.

    Product
    KIA — KIA FORTE, SEDONA, OPTIMA, OPTIMA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V362000·2018-06-01

    Starcraft Telluride Fifth-Wheel Trailer Propane Strap Recall

    Starcraft is recalling 2019 Telluride fifth-wheel trailers because the propane tank strap may separate, increasing the risk of a crash or fire.

    Product
    STARCRAFT RV FW — STARCRAFT RV FW TELLURIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V367000·2018-06-01

    MORryde Recalls 2018 Ford E-450 Chassis Due to Loose U-Bolts

    MORryde is recalling 2018 Ford E-450 chassis modified for transit bus use because insufficiently tightened U-bolts may allow the rear axle to separate, increasing crash risk.

    Product
    FORD — FORD E-450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E037000·2018-05-31

    Dorman Front Control Arms Recalled for Potential Steering Loss

    Dorman is recalling specific front control arms where a ball stud may pull through the steering knuckle, causing partial loss of steering.

    Product
    SUSPENSION:FRONT:CONTROL ARM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V358000·2018-05-31

    GM Recalls 2015-2018 Vehicles for Fuel Pump Fire Risk

    General Motors is recalling specific 2015-2018 GMC, Chevrolet, Buick, and Cadillac vehicles because a fuel pump may detach and cause a leak, increasing fire risk.

    Product
    GMC — GMC, CHEVROLET, BUICK CANYON, MALIBU, ENVISION, ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V359000·2018-05-31

    Kenworth Recalls 2019 T270 and T370 Trucks for Axle Nut Issue

    PACCAR is recalling 2019 Kenworth T270 and T370 vehicles because over-tightened rear axle nuts may cause bearing failure or fire, increasing crash risk.

    Product
    KENWORTH — KENWORTH T270, T370
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1480-2018·2018-05-30

    FDA Recalls Nature's Only Choice B17 Apricot Extract Dietary Supplement

    Nature's Only Choice is recalling B17 Bitter Raw Apricot Extract Amygdalin dietary supplements because the product is considered an unapproved new drug.

    Product
    Nature's Only Choice B17 BITTER RAW APRICOT EXTRACT AMYGDALIN Dietary Supplement 100 Capsules
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0835-2018·2018-05-30

    Ideaz Recalls Screamin' Menthol Pain Gel Due to Benzene Levels

    Ideaz Llc is recalling Screamin' Menthol Pain Relieving Gel because it contains benzene levels exceeding FDA limits.

    Product
    screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC…
    Category
    Drug
    Distribution
    Distributed nationwide