The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

8001–8025 of 29123

  • SevereCPSC·21173·2021-07-29

    Generac Portable Generators Recalled for Finger Amputation Hazard

    Generac is recalling about 321,160 portable generators (6500 and 8000 watt models) because an unlocked handle can pinch and amputate consumers' fingers when the generator is moved. Eight injuries have been reported, including seven finger amputations.

    Product
    Generac® and DR® 6500 Watt and 8000 Watt portable generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V580000·2021-07-29

    Sutphen Fire Truck Recall: Fuel Rail Leak Risk

    Sutphen is recalling 2017-2020 Fire Trucks because a sealing washer may not seat correctly, causing the high-pressure fuel rail to leak and increasing fire risk.

    Product
    SUTPHEN — SUTPHEN FIRE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V586000·2021-07-29

    BMW Recalls 11,216 Vehicles for High-Pressure Fuel Pump Failure Risk

    BMW is recalling 11,216 vehicles from 2014-2018 because a high-pressure fuel pump failure could cause the engine to stall while driving, increasing the risk of a crash.

    Product
    BMW — BMW 328D, 535D, X5, 740LD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0683-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Methanol and Benzene Contamination

    Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Tropical Daydream spray due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide.

    Product
    Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01335 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0667-2021·2021-07-28

    SS Coconut Breeze Scented Sanitizer Recalled for Chemical Contamination

    SS Coconut Breeze Scented Sanitizer has been recalled due to contamination with methanol, benzene, and acetaldehyde. The 3.38 FL. OZ. bottles were distributed nationwide.

    Product
    SS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Black and White Collection; b) Photo Real Collection
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0693-2021·2021-07-28

    Compounded Lyophilized AOD-9604 Injection Recalled for Sterility Risk

    Innoveix Pharmaceuticals is recalling compounded lyophilized AOD-9604 3 mg injection vials nationwide due to lack of assurance of sterility. The affected product was distributed as Rx-only injectable medication.

    Product
    Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0687-2021·2021-07-28

    Thumbs Up 7 White Capsules Recalled for Undeclared Pharmaceutical Ingredients

    Nuri Trading LLC is recalling Thumbs Up 7 White 11K capsules nationwide because they contain undeclared prescription drug ingredients (tadalafil, sildenafil, and vardenafil) and lack FDA approval.

    Product
    Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0669-2021·2021-07-28

    SS Lavender & Herbs Scented Sanitizer Recalled for Chemical Contamination

    Scentsational Soaps & Candles Inc is recalling SS Lavender & Herbs Scented Sanitizer due to contamination with methanol, benzene, and acetaldehyde. The affected product was distributed nationwide.

    Product
    SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0676-2021·2021-07-28

    Goose Creek Hand Sanitizer Spray Recalled for Chemical Contamination

    Goose Creek Hand Sanitizer aloe Champagne Bubbles spray (3.38 FL. OZ.) has been recalled because it is contaminated with methanol, benzene, and acetaldehyde. Consumers should stop using the product immediately.

    Product
    Goose Creek Hand Sanitizer aloe Champagne Bubbles, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01334 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0668-2021·2021-07-28

    SS Eucalyptus Mint Scented Sanitizer Recalled for Chemical Contamination

    Scentsational Soaps & Candles Inc is recalling SS Eucalyptus Mint Scented Sanitizer due to contamination with methanol, benzene, and acetaldehyde. The affected product was distributed nationwide.

    Product
    SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Black and White Collection; b) Photo Real Collection
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0678-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Chemical Contamination

    Goose Creek Hand Sanitizer aloe Marshmallows (3.38 FL. OZ.) is recalled nationwide due to contamination with methanol, benzene, and acetaldehyde. Consumers should stop using the product immediately.

    Product
    Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01331 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2074-2021·2021-07-28

    Philips Respironics V60 Plus Ventilator software defect reduces oxygen delivery to patients

    Respironics V60 Plus Ventilators (software versions 3.00 and 3.10) may reduce oxygen flow below clinical settings, risking oxygen desaturation and hypoxemia in mechanically ventilated patients.

    Product
    Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V576000·2021-07-28

    New Flyer Recalls 2021 XD35 and XD40 Buses for Fuel Leak Risk

    New Flyer is recalling 2021 XD35 and XD40 buses with Cummins L9 engines due to a potential fuel hose leak that could cause a fire.

    Product
    NEW FLYER — NEW FLYER XD35, XD40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0684-2021·2021-07-28

    Coconut Stand CoCo TKO Hand Sanitizer Contaminated with Methanol, Benzene, Acetaldehyde

    Scentsational Soaps & Candles Inc is recalling Coconut Stand CoCo TKO Hand Sanitizer due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide in 3.4 FL. OZ. bottles.

    Product
    Coconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4 FL. OZ. (100.55 mL), Distributed by: Beauty Sparks LLC St. Petersburg, FL 33711
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0674-2021·2021-07-28

    Goose Creek Hand Sanitizer recalled for methanol and benzene contamination

    Goose Creek Hand Sanitizer aloe Beach Dreams spray (3.38 FL. OZ.) is being recalled because it is contaminated with methanol, benzene, and acetaldehyde. The product was distributed nationwide.

    Product
    Goose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandles.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 18489 01336 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0670-2021·2021-07-28

    SS Lemon Zest Scented Sanitizer contaminated with methanol and benzene

    Scentsational Soaps & Candles Inc is recalling SS Lemon Zest Scented Sanitizer due to contamination with methanol, benzene, and acetaldehyde. The affected product was distributed nationwide.

    Product
    SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0675-2021·2021-07-28

    Goose Creek Hand Sanitizer Spray Recalled for Chemical Contamination

    Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Grape Soda spray because it contains methanol, benzene, and acetaldehyde. The contaminated product was distributed nationwide.

    Product
    Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01328 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0680-2021·2021-07-28

    Goose Creek Hand Sanitizer Contaminated With Methanol, Benzene, Acetaldehyde

    Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Optimistic Vibes spray due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide.

    Product
    Goose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02234 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0666-2021·2021-07-28

    Ulta Beauty Hand Sanitizer Spray Recalled for Chemical Contamination

    Ulta beauty Fresh Lemon Citron Frais Hand Sanitizer Spray is being recalled because the product contains methanol, benzene, and acetaldehyde. Affected lot numbers are 20357A, 20358B, and 20363C with expiration date 12/1/2022.

    Product
    Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net Wt. 100.55/3.4 fl. oz., UPC 717897092017
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0681-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Chemical Contamination

    Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray (3.38 FL. OZ.) is being recalled nationwide because it is contaminated with methanol, benzene, and acetaldehyde.

    Product
    Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02045 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2073-2021·2021-07-28

    Philips Respironics V60 Ventilator Flow Rate Reduction Safety Defect

    Philips Respironics V60 ventilators with High Flow Therapy software versions 3.00 and 3.10 may reduce oxygen delivery below prescribed levels when pressure limits are reached, risking oxygen desaturation.

    Product
    Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0664-2021·2021-07-28

    Thumbs Up 7 Red Capsules Recalled for Undeclared Active Pharmaceutical Ingredients

    Ummzy LLC is recalling Thumbs Up 7 Red 70K capsules because they contain undeclared tadalafil and/or sildenafil and vardenafil, making them unapproved drugs with unestablished safety and efficacy.

    Product
    Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0692-2021·2021-07-28

    Compounded Semorelin/Ipamorelin Injection Recalled for Sterility Assurance

    Innoveix Pharmaceuticals is recalling 728 vials of compounded Semorelin/Ipamorelin 3 mg injection due to lack of assurance of sterility. The affected lots are SIP215, SIP220, and SIP210.

    Product
    Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0688-2021·2021-07-28

    69MODE Blue 69 Capsules Recalled for Undeclared Drug Ingredients

    Nuri Trading LLC is recalling 69MODE Blue 69 capsules nationwide because they contain undeclared tadalafil and sildenafil, two FDA-approved drugs, making the product an unapproved drug without established safety or efficacy.

    Product
    69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0672-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Chemical Contamination

    Goose Creek Hand Sanitizer aloe Blueberry Limeade spray has been recalled due to contamination with methanol, benzene, and acetaldehyde. The product should not be used.

    Product
    Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 14630 02049 5
    Category
    Drug
    Distribution
    Distributed nationwide