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.

14651–14675 of 29199

  • SevereFDA (Devices)·Z-1104-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage

    Boston Scientific is recalling certain Malecot Nephrostomy Catheters because they are breaking at the mid-shaft bond during use.

    Product
    Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V200000·2018-03-28

    Toyota Recalls 2018 Camry Vehicles Due to Engine Piston Defect

    Toyota is recalling 2018 Camry vehicles with 2.5L engines because oversized pistons may cause the engine to stall, increasing crash risk.

    Product
    TOYOTA — TOYOTA CAMRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V198000·2018-03-27

    Newmar Recalls Motorhomes Due to Power Steering Hose Routing Defect

    Newmar is recalling 2011-2017 Mountain Aire, Dutch Star, and Ventana motorhomes because the power steering hose may rub against the starter motor, causing fluid leaks or electrical arcing.

    Product
    NEWMAR — NEWMAR MOUNTAIN AIRE, DUTCH STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V191000·2018-03-26

    Western Star Trucks Recalled for Electrical Arc Fire Risk

    Daimler Trucks North America is recalling 2017-2019 Western Star trucks because a power stud may contact the bulkhead, causing an electrical arc that increases fire risk.

    Product
    WESTERN STAR — WESTERN STAR 6900, 4900, 4700, 5700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V192000·2018-03-26

    Thomas Built Buses Recall School Buses Due to Seat Bracket Crack Risk

    Daimler Trucks North America is recalling 2014-2018 Thomas Built Buses school buses because a wall mounting bracket may crack, causing seats to detach in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, MINOTOUR, SAF-T-LINER C2, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V190000·2018-03-26

    Thomas Built Buses Saf-T-Liner C2 Propane Leak Recall

    Daimler Trucks North America is recalling 2014-2019 Thomas Built Buses Saf-T-Liner C2 school buses with propane engines due to a fuel line chafing risk that could cause a leak and fire.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V193000·2018-03-26

    Thomas Built Buses Recall Transit Models Due to Seat Bracket Defect

    Daimler Trucks North America is recalling 2014-2018 Thomas Built Buses transit models because a wall mounting bracket may crack, increasing injury risk in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX, SAF-T-LINER C2, MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V188000·2018-03-23

    Ferrari Recalls 458 Italia and California Models for Air Bag Defect

    Ferrari is recalling 2009-2011 California and 2010-2011 458 Italia vehicles because passenger air bag inflators may explode during a crash, posing a risk of serious injury or death.

    Product
    FERRARI — FERRARI 458 ITALIA, CALIFORNIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0984-2018·2018-03-21

    Alden Optical Recalls HP49 Sphere Daily Wear Soft Contact Lenses

    Alden Optical is recalling 23 units of HP49 Sphere Daily Wear Soft contact lenses because they lack sterility assurance.

    Product
    Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Product Usage: The ALDEN SPHERE 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V184000·2018-03-21

    MaxxD Recalls 2017-2018 A3X, A5X, and A6X Trailers for Suspension Defect

    Maxey Trailers is recalling 2017-2018 A3X, A5X, and A6X trailers because suspension arms may crack, potentially causing the axle to come loose and increasing crash risk.

    Product
    MAXXD — MAXXD A5X, A3X, A6X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0930-2018·2018-03-21

    Plant Devas Blemish Face Care Kit Recalled for Microbial Contamination

    Plant Devas Inc. is recalling Blemish Face Care Kits because FDA sampling found excessive and virulent microorganisms.

    Product
    Blemish Face Care Kit; Each kit contains: Tea Tree Gel Cleanser 1 fl oz bottle Lemon Thyme Facial Tonic HydroSoul 1 fl oz bottle Pomegranate Repair Serum 0.13 fl oz vial Green Tea Clay 0.1 oz. jar Blemish Purifying Serum 0.06 fl oz vial Light Moisture…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0931-2018·2018-03-21

    Plant Devas Ayurvedic Face Care Kit Recalled for Microbial Contamination

    Plant Devas Inc. is recalling 144 units of Ayurvedic Face Care Kits because FDA testing found excessive numbers of microorganisms.

    Product
    Ayurvedic Face Care Kit; Each kit contains: Coconut Cream Cleanser 0.5 fl oz jar Tulsi Facial Tonic HydroSoul 1 fl oz bottle Argan Intensive Facial Serum 0.13 fl oz vial Neem Immortelle Purifying Infusion 0.13 fl oz vial Lemongrass Facial Polish 0.4 oz jar…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0985-2018·2018-03-21

    Alden Optical Recalls Contact Lenses Lacking Sterility Assurance

    Alden Optical is recalling specific daily wear soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.

    Product
    Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The ALDEN SPHERE 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-0587-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling 176,410 vials of methylprednisolone sodium succinate injection due to high impurity levels.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0597-2018·2018-03-21

    Pfizer Recalls Hydromorphone Hydrochloride Injection Vials Due to Non-Sterility

    Pfizer is recalling 29,680 vials of Hydromorphone Hydrochloride Injection due to confirmed customer complaints of empty or cracked glass containers.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0981-2018·2018-03-21

    Alden Optical Recalls NovaKone Daily Wear Soft Contact Lenses

    Alden Optical is recalling NovaKone Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the US and Canada.

    Product
    NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1073-2018·2018-03-21

    Smiths Medical Recalls Misassembled Port-A-Cath Implantable Port Kits

    Smiths Medical ASD Inc. is recalling certain Port-A-Cath II kits that may contain incorrect introducer sizes or locking collars due to misassembly.

    Product
    PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V185000·2018-03-21

    Forest River Surveyor Recalled for Refrigerator Fire Risk

    Forest River is recalling 2018 Surveyor trailers because a missing fan in the refrigerator may cause overheating and fire.

    Product
    FOREST RIVER — FOREST RIVER SURVEYOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0588-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling methylprednisolone sodium succinate for injection vials due to high impurity levels. The affected lots were distributed nationwide.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0912-2018·2018-03-21

    Testosterzone dietary supplement recalled for undeclared milk allergen

    Progressive Laboratories is recalling Testosterzone dietary supplements because they may contain undeclared milk, a major food allergen.

    Product
    Testosterzone 180 count bottle packaged in an amber plastic bottle with a black cap
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0924-2018·2018-03-21

    Plant Devas Clay Mask Kit Recalled for Excessive Microorganisms

    Plant Devas Inc. is recalling 500 kits of the evanhealy Clay Mask Kit because FDA testing found excessive and virulent microorganisms.

    Product
    Clay Mask Kit; 2 glass jars of clay: Green Tea Clay 0.3 oz., and French Rose Clay 0.4 oz. 1 fan mask brush; and 1 terra cotta mixing bowl. Ingredients: Green tea clay, Green (Montmorillonite) clay, Organic Green Tea (Camellia Sinensis) French Rose Clay, Rose Clay (Kaolin…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0927-2018·2018-03-21

    Plant Divas Green Tea Clay Recalled for Excessive Microorganisms

    Plant Divas Inc. is recalling Green Tea Clay because FDA testing found excessive and virulent microorganisms in the product.

    Product
    Green Tea Clay; 2.1 and 0.17 oz. jars evanhealy Hand Made in CA by Plant Divas Inc., San Diego, CA 92064
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0991-2018·2018-03-21

    Alden Optical Recalls ASTERA Multifocal Toric Contact Lenses for Sterility Issues

    Alden Optical is recalling ASTERA Multifocal Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.

    Product
    ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0926-2018·2018-03-21

    Plant Divas Clay Products Recalled for Excessive Microorganisms

    Plant Divas Inc. is recalling French Rose Clay and Moroccan Rhassoul Clay products because FDA testing found excessive numbers of microorganisms.

    Product
    French Rose Clay; with Mineral Rish Moroccan Rhassoul Clay 2.1 and 0.17 oz. jars evanhealy Hand Made in CA by Plant Divas Inc., San Diego, CA 92064
    Category
    Consumer Product
    Distribution
    Distributed nationwide