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.

14676–14700 of 29199

  • SevereFDA (Devices)·Z-0990-2018·2018-03-21

    Alden HP59 Toric Contact Lenses Recalled for Lack of Sterility Assurance

    Alden Optical is recalling HP59 Toric Daily Wear Soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.

    Product
    Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0586-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling 205,370 vials of methylprednisolone sodium succinate for injection due to high impurity levels.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0913-2018·2018-03-21

    Progressive Laboratories Recalls Thyroid Resilience Supplement for Undeclared Milk

    Progressive Laboratories is recalling Thyroid Resilience dietary supplements because they may contain undeclared milk. Consumers should stop using the product and return it to the place of purchase.

    Product
    Thyroid Resilience 120 count bottle packaged in an amber plastic bottle with black cap
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1071-2018·2018-03-21

    Zimmer Biomet Recalls TunneLoc Tibial Fixation Devices Due to Sterilization Concerns

    Zimmer Biomet is recalling 14,461 TunneLoc Tibial Fixation Devices because gamma sterilization testing suggests the sterilization dose may be inadequate.

    Product
    TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·025-2018·2018-03-21

    California Jerky Factory Recalls Beef Jerky Due to Processing Deviation

    California Jerky Factory is recalling approximately 1,238 pounds of beef jerky products due to a processing deviation that may have led to under-processing.

    Product
    California Jerky Factory, Inc. — California Jerky Factory, Inc. Recalls Beef Jerky Products Due to Possible Processing Deviation
    Category
    Food
    Distribution
    3 states
  • SevereUSDA FSIS·024-2018·2018-03-20

    Mickey Brown Recalls Beef Burritos Produced Without Federal Inspection

    Mickey Brown, Inc. is recalling beef burrito products produced without federal inspection. No adverse reactions have been reported.

    Product
    Mickey Brown, Inc. — Mickey Brown, Inc Recalls Beef Burrito Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V179000·2018-03-19

    Forest River Recalls Motorhomes Due to Power Steering Hose Fire Risk

    Forest River is recalling specific 2012-2017 motorhomes because an incorrectly routed power steering hose may rub against the starter motor, causing electrical arcing and a fire risk.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN, GLAVAL BUS CHARLESTON, BERKSHIRE, PATHFINDER, CROSS COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V182000·2018-03-19

    McElrath Trailers Recalling 2013-2018 Models Due to Weld Failure Risk

    McElrath Trailers is recalling specific 2013-2018 models because a weld on the trailer neck may fail, potentially causing loss of control and a crash.

    Product
    MCELRATH TRAILERS — MCELRATH TRAILERS VX50-800, 818I, VX30-800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V181000·2018-03-19

    Entegra Aspire Recalled for Power Steering Hose Fire Risk

    Entegra Coach is recalling 2011-2012 and 2015-2016 Aspire motorhomes because an incorrectly routed power steering hose may cause electrical arcing and a fire.

    Product
    ENTEGRA — ENTEGRA ASPIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V183000·2018-03-19

    REV Recalls 2018 Motorhomes Due to HVAC Fire Risk

    REV Recreation Group is recalling 600 2018 motorhomes because HVAC wires may disconnect, creating a fire risk if reconnected incorrectly.

    Product
    MONACO — MONACO, AMERICAN COACH, FLEETWOOD SIGNATURE, MARQUIS, AMERICAN REVOLUTION, AMERICAN DREAM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18T002000·2018-03-16

    Les Schwab Recalls Retreaded Truck Tires Due to Adhesion Defect

    Les Schwab is recalling specific retreaded steel-belted radial truck tires because the vulcanizing compound may not have fully cured, increasing the risk of tread separation and crashes.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V178000·2018-03-15

    Hino Recalls 2018-2019 Trucks Due to Engine Valve Train Defect

    Hino is recalling 2018-2019 NE8J, NJ8J, and NV8J trucks because engine valve train lock nuts may be loose, potentially causing engine damage and shutdown.

    Product
    HINO — HINO NJ8J, NV8J, NE8J
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·022-2018·2018-03-15

    Standard Meat Company Recalls Raw Beef Steaks Due to Salmonella Risk

    Standard Meat Company is recalling raw beef top sirloin steaks that may be contaminated with Salmonella. The products were shipped to restaurants nationwide.

    Product
    Standard Meat Company — Standard Meat Company Recalls Beef Products Due to Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·021-2018·2018-03-15

    Johnsonville Recalls Smoked Pork Sausage Due to Possible Plastic Contamination

    Johnsonville is recalling approximately 109,603 pounds of smoked pork sausage products that may contain hard, green plastic pieces.

    Product
    Johnsonville, LLC — Johnsonville, LLC Recalls Smoked Pork Sausage Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0579-2018·2018-03-14

    Apollo Care Recalls Vancomycin IV Bags Due to Stability Data Issues

    Apollo Care is recalling 360 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.

    Product
    Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·18V172000·2018-03-14

    KME Predator Fire Apparatus Recalled for Front Axle Spindle Defect

    Kovatch Mobile Equipment is recalling specific KME Predator fire apparatus vehicles because inconsistent machining may cause front axle spindles to crack and fail, potentially leading to wheel separation.

    Product
    KME — KME PREDATOR TANKER, PREDATOR RESCUE, PREDATOR AERIAL, PREDATOR PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V173000·2018-03-14

    Maserati Recalls 2017 Quattroporte and Ghibli for Engine Software Defect

    Maserati is recalling 2017 Quattroporte and Ghibli vehicles because an engine software issue may cause the transmission to shift into neutral or the engine to shut off unexpectedly.

    Product
    MASERATI — MASERATI QUATTROPORTE, GHIBLI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2018·2018-03-14

    FDA Recalls 163 Endo GIA Radial Reloads Due to Manufacturing Error

    The FDA is recalling 163 Endo GIA Radial Reloads with Tri-Staple Technology because the device cartridge disengaged during use due to a manufacturing error.

    Product
    Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0580-2018·2018-03-14

    Apollo Care Recalls Vancomycin IV Bags Due to Unsupported Expiry Date

    Apollo Care is recalling 312 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.

    Product
    Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-264-25.
    Category
    Drug
    Distribution
    1 state