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.

13401–13425 of 29188

  • SevereFDA (Drugs)·D-0142-2019·2018-11-07

    Bi-Mix Injection Recalled for Lack of Sterility Assurance

    Pharm D Solutions is recalling Bi-Mix Injection due to a lack of assurance of sterility. The product is distributed nationwide.

    Product
    Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1305-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0202-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Injection Due to Sterility Concerns

    Pharm D Solutions is recalling 195 vials of Trimix injection nationwide due to a lack of assurance of sterility.

    Product
    Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1369-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·19713·2018-11-07

    Kubota Recalls Mowers and Tractors Due to Coolant Burn Hazard

    Kubota is recalling about 121,100 mowers and compact tractors because hot coolant can spray out, posing a burn hazard. Three burn injuries have been reported.

    Product
    Kubota zero turn mowers, compact tractors, and ride-on mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0196-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Injection Due to Sterility Concerns

    Pharm D Solutions is recalling Trimix 30-1-30 aqueous solution because the company cannot assure the product's sterility.

    Product
    Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1319-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0347-2019·2018-11-07

    Hy-Vee Twice Baked Potatoes Recalled for Listeria and Salmonella Risk

    D & D Foods is recalling Hy-Vee Spinach, Tomato, Mozzarella Twice Baked Potatoes because raw ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Hy-Vee Spinach, Tomato, Mozzarella Twice Baked Potatoes, Net Wt. 5 oz wrapped in clear plastic.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0204-2019·2018-11-07

    Pharm D Solutions Recalls Trimix ST-9B Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Trimix ST-9B aqueous solution because the company cannot guarantee the product's sterility.

    Product
    Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1344-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V783000·2018-11-06

    Blue Bird Recalls 2017-2019 Vision School Buses Due to Fire Risk

    Blue Bird is recalling 2017-2019 Vision school buses because alternator cables may chafe, causing an electrical short and increasing the risk of a fire.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V781000·2018-11-06

    Lotus Recalls 2018 Evora Vehicles for Steering Column Assembly Error

    Lotus is recalling 2018 Evora vehicles because an assembly error may prevent the steering column from collapsing properly in a frontal collision, increasing injury risk.

    Product
    LOTUS — LOTUS EVORA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·109-2018·2018-11-06

    Ganaderos Borges Recalls Pork Patties Due to Metal Contamination

    Ganaderos Borges is recalling approximately 14,760 pounds of raw pork patties that may contain metal. The products were distributed to institutional locations in Puerto Rico.

    Product
    Ganaderos Borges — Ganaderos Borges, Inc. Recalls Pork Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V785000·2018-11-06

    Keystone Montana Recalled for Potential Brake Fastener Failure

    Keystone is recalling 2019 Montana recreational trailers with the Legacy package because brake fasteners may fail, causing loss of braking ability.

    Product
    KEYSTONE — KEYSTONE MONTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V780000·2018-11-05

    Thor Aria and Venetian Motorhomes Recalled for Brake Caliper Bolts

    Thor Motor Coach is recalling 2018-2019 Aria and Venetian motorhomes because brake caliper mounting bolts may be insufficiently tightened, increasing crash risk.

    Product
    THOR — THOR, THOR MOTOR COACH ARIA, VENETIAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V779000·2018-11-02

    Triple E Recalls 2019 Unity Motorhomes Due to Brake Line Contact

    Triple E is recalling 2019 Unity motorhomes because a support bracket may contact the brake line, causing fluid leaks and reduced braking ability.

    Product
    TRIPLE E — TRIPLE E UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V774000·2018-11-01

    GM Recalls 2019 Vehicles Due to Air Bag Module Defect

    General Motors is recalling 2019 Buick Encore, Chevrolet Spark, Traverse, and Trax vehicles because the air bag module may not be programmed correctly, preventing deployment in a crash.

    Product
    CHEVROLET — CHEVROLET, BUICK SPARK, TRAX, TRAVERSE, ENCORE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V775000·2018-11-01

    Ford Recalls 2010-2012 Vehicles for Passenger Air Bag Defect

    Ford is recalling specific 2010-2012 vehicles to replace passenger air bag modules that may fail to inflate properly in a crash.

    Product
    LINCOLN — LINCOLN, MERCURY, FORD MKZ, MILAN, FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V777000·2018-11-01

    Honda and Acura Recall Vehicles for Rear Brake Caliper Coating Defect

    Honda is recalling specific 2016-2019 HR-V, Odyssey, and Acura MDX models because rear brake caliper pistons may have insufficient coating, reducing braking performance.

    Product
    HONDA — HONDA, ACURA HR-V, ODYSSEY, MDX, MDX SPORT HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V778000·2018-11-01

    Mack Recalls 2019 Trucks Due to Potential Steering Shaft Separation

    Mack Trucks is recalling 2019 Anthem, Granite, and Pinnacle vehicles because a loose pinch bolt may allow the steering shaft to separate, causing loss of steering.

    Product
    MACK — MACK PINNACLE (PI/PN), ANTHEM (AN), GRANITE (GR)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0249-2019·2018-10-31

    McCain Recalls Fire-Roasted Diced Tomatillos Due to Listeria and Salmonella Testing Issues

    McCain Foods USA is recalling Fire-Roasted 1/2" Diced Tomatillos because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted 1/2" Diced Tomatillos; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0238-2019·2018-10-31

    McCain Foods Recalls Fire Roasted Diced Onion and Pepper Blend

    McCain Foods USA is recalling Fire Roasted 1/2" Diced Onion/Pepper Blend because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted 1/2" Diced Onion/Pepper Blend; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0223-2019·2018-10-31

    McCain Fire-Roasted Vegetable Blend Recalled for Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted Vegetable Blend because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted Rubio's Vegetable Blend: Sold in 2 lb. Brand Name: Chef Sensations¿
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0232-2019·2018-10-31

    McCain Foods Recalls Fire Roasted Diced Poblano Chiles Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted 1/2" Diced Poblano Chiles because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted 1/2" Diced Poblano Chiles; Sold in 25 lb. containers. Brand Name:Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0243-2019·2018-10-31

    CHS Cotton Tip Applicators Recalled Due to Sterility Compromise

    Custom Healthcare Systems is recalling 150 units of CHS Cotton Tip Applicators because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Food)·F-0061-2019·2018-10-31

    Blackwing Organic Meats Recalls Ground Venison Due to High Lead Levels

    Blackwing Organic Meats, Inc. is voluntarily recalling specific packages of ground venison because they contain high levels of lead.

    Product
    Blackwing Meats. Inc., Ground Venison, 10/1lb, packed in cardboard sleeve/ roll stock film inside, in aRetail Box.
    Category
    Food
    Distribution
    2 states