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.

14551–14575 of 29192

  • SevereFDA (Drugs)·D-0649-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Pregnenolone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Pregnenolone 100 mg pellets because they were sterilized using a non-approved method.

    Product
    Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1411-2018·2018-04-25

    Philips Brilliance Big Bore CT Systems Recalled for Emergency Stop Defect

    Philips is recalling 119 Brilliance Big Bore CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient load or unload.

    Product
    Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0645-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Injectable Solution Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling TM #1 Injectable solution because a non-approved sterilization method was used. The product was distributed only in Nevada.

    Product
    TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0666-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone 40 mg pellets in Nevada due to a non-approved sterilization method.

    Product
    Testosterone 40 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0665-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone 37.5 mg pellets because they were sterilized using a non-approved method.

    Product
    Testosterone 37.5 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0660-2018·2018-04-25

    Partell Specialty Pharmacy Recalls TM Drug Vials Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling specific lots of TM drug vials because they were sterilized using a non-approved method.

    Product
    TM (ALP 50/PAPAV 30/PHENT1.5 mg), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·18V260000·2018-04-24

    Hyundai Recalls 2017 Ioniq Hybrid Vehicles for Fire Risk

    Hyundai is recalling 2017 Ioniq Hybrid vehicles because a leaking oil seal may cause an electrical short, increasing the risk of a fire.

    Product
    HYUNDAI — HYUNDAI IONIQ HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V257000·2018-04-20

    Kia Recalls 2017 Niro Vehicles Due to Hybrid System Fire Risk

    Kia is recalling 2017 Niro vehicles because a leaking hydraulic clutch actuator seal may cause an electrical short, increasing the risk of a fire.

    Product
    KIA — KIA NIRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V255000·2018-04-20

    Altec Recalls 1992-2006 Digger Derrick Trucks Due to Boom Pivot Pin Failure

    Altec Industries is recalling 1992-2006 Digger Derrick trucks because a specific boom pivot pin may fail, causing unexpected boom movement that increases the risk of injury or death.

    Product
    ALTEC — ALTEC DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V256000·2018-04-20

    Supreme Recalls 2013-2017 Kold King Vehicles Due to Frame Rail Defect

    Supreme Corporation is recalling 2013-2017 Kold King vehicles because the floor frame rail may detach from cross members due to insufficient weld penetration.

    Product
    SUPREME — SUPREME KOLD KING
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E024000·2018-04-19

    Bosch Electric Power Steering System Recall for Corroding Bolts

    Bosch is recalling electric power steering systems where aluminum bolts may corrode and fracture, potentially causing loss of steering assist.

    Product
    STEERING:ELECTRIC POWER ASSIST SYSTEM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V251000·2018-04-19

    Freightliner M2 Trucks Recalled for Rear Brake Caliper Orientation Issue

    Daimler Trucks is recalling 2016-2019 Freightliner Business Class M2 trucks because rear brake calipers may be mounted incorrectly, reducing braking effectiveness.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V249000·2018-04-19

    Coachmen Spirit Recalled for Missing LP Quick Disconnect on Cooktop

    Forest River is recalling 2018-2019 Coachmen Spirit trailers because the outdoor cooktop may lack a liquid propane quick disconnect, posing carbon monoxide and fire risks.

    Product
    COACHMEN — COACHMEN SPIRIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V254000·2018-04-19

    Thomas Built Buses Recall Wall-Mounted Seats Due to Crash Risk

    Daimler Trucks North America is recalling 2014-2018 Thomas Built Buses because wall-mounted seat brackets may crack, increasing injury risk in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR, SAF-T-LINER EFX, SAF-T-LINER HDX, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1115-2018·2018-04-18

    Peru Chef Dry Potato Recalled for Undeclared Sulfites

    MAS Food Services is recalling The Peru Chef Dry Potato because it contains undeclared sulfites, posing a risk to sensitive individuals.

    Product
    The Peru Chef Dry Potato, Product of Peru, Net Wt. 15oz/425gr, Imported and Distributed by MAS FOOD SERVICES Co.,
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·18V248000·2018-04-18

    BMW Recalls Vehicles for Electric Water Pump Fire Risk

    BMW is recalling 2007-2012 models because a failing electric auxiliary water pump can overheat the circuit board, increasing the risk of a fire.

    Product
    BMW — BMW, MINI, ROLLS-ROYCE X5, COOPER S CONVERTIBLE, X6 ACTIVEHYBRID SAC, X6 M
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1365-2018·2018-04-18

    Fresenius Liberty Select Cycler Recalled for Software Overfill Risk

    Fresenius Medical Care is recalling Liberty Select Cyclers due to a software issue that may cause overfill, posing a risk of serious injury or death.

    Product
    Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V247000·2018-04-18

    Volkswagen Recalls 2006-2007 Passat Vehicles Due to Air Bag Inflator Defect

    Volkswagen is recalling 2006-2007 Passat sedans and wagons because the driver's air bag inflator may explode during deployment, posing a risk of serious injury or death.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT, PASSAT WAGON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1351-2018·2018-04-18

    W & H DentalWerk Recalls S-N1 and S-N2 Foot Controls

    W & H DentalWerk is recalling S-N1 and S-N2 foot controls because they may fail to stop the motor, posing a risk of serious patient injury.

    Product
    Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1314-2018·2018-04-18

    Terumo Cardiovascular Procedure Kits Recalled for Potential Blood Leaks

    Terumo is recalling 2,677 Cardiovascular Procedure Kits containing Pall LG6NS filters due to a risk of blood leaks through the hydrophobic portion.

    Product
    Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use…
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1318-2018·2018-04-18

    Reliance Medical Products Recalls Refractor Suspension Arms Due to Missing Parts

    Reliance Medical Products is recalling 933 Refractor Suspension Arms because missing parts caused the device to fall on a patient.

    Product
    Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide