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.

25201–25225 of 32194

  • SevereFDA (Devices)·Z-2206-2014·2014-08-20

    Gambro Recalls PrisMARS Kits Due to Connector Breakage and Leakage

    Gambro Renal Products is recalling PrisMARS Kits because connector breakages can cause liquid or blood to leak.

    Product
    PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·14V508000·2014-08-19

    NABI Recalls 2014 BRT and LFW Buses Due to Fuel Filter Defect

    NABI is recalling 35 model year 2014 BRT and LFW transit buses because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    NABI — NABI BRT, LFW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V504000·2014-08-18

    Dakota Air Ride Trailers Recalled for Suspension Pivot Bolt Failure Risk

    Dakota Trailer Manufacturing is recalling 2014 Air Ride Grain and Side Dump trailers because suspension pivot bolts may fail, potentially causing the axle to separate and increasing crash risk.

    Product
    DAKOTA GRAIN — DAKOTA GRAIN, DAKOTA SIDE DUMP AIR RIDE GRAIN, AIR RIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V507000·2014-08-18

    Jerr-Dan Recalls Ford Super Duty Trucks Due to Fire Risk

    Jerr-Dan is recalling 2009-2014 Ford F-350, F-450, and F-550 Super Duty trucks modified with specific PTO assemblies. Oil leaks from the PTO pressure switch may soak the exhaust thermal blanket, increasing fire risk.

    Product
    FORD — FORD F-550 SUPER DUTY, F-450 SUPER DUTY, F-350 SUPER DUTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V505000·2014-08-18

    Spartan Emergency Vehicles Recalled for Fuel Filter Defect

    Spartan is recalling 2013-2015 emergency vehicles and chassis because fuel filters may separate, causing the engine to stall without warning.

    Product
    SPARTAN — SPARTAN SB, GLADIATOR, METROSTAR, MM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V506000·2014-08-18

    Winnebago Vista and Itasca Sunstar Motorhomes Recalled for Fire Risk

    Winnebago is recalling 2015 Vista and Itasca Sunstar motorhomes because a missing damper plate could allow air to blow out the range flame, potentially causing a propane fire.

    Product
    WINNEBAGO — WINNEBAGO VISTA, ITASCA SUNSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·053-2014·2014-08-15

    Whole Foods Recalls Ground Beef Due To Possible E. Coli O157:H7 Contamination

    Whole Foods Market is recalling 368 pounds of ground beef products in Massachusetts due to possible E. coli O157:H7 contamination linked to three confirmed illnesses.

    Product
    Massachusetts Firm Recalls Ground Beef Products Due To Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V503000·2014-08-15

    Altec Recalls Aerial Devices and Digger Derricks Due to Fire Risk

    Altec is recalling 2000-2013 Aerial Devices and Digger Derricks because a battery equalizer component may conduct electricity and cause a fire.

    Product
    ALTEC — ALTEC AERIAL DEVICE, DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V502000·2014-08-14

    Jayco Recalls 2014-2015 Precept Motorhomes Due to Fire Risk

    Jayco is recalling 2014-2015 Precept motorhomes because damaged seat wiring may short and cause a fire. Owners should contact dealers for free repairs.

    Product
    JAYCO — JAYCO PRECEPT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1524-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer

    Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin 5000 Injection USP because the manufacturer is not registered with the FDA.

    Product
    Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1512-2014·2014-08-13

    Alexion Recalls Soliris Vials Due to Visible Particulate Matter

    Alexion Pharmaceuticals is recalling 96,506 vials of Soliris (eculizumab) because the product failed appearance tests for visible particles under labeled storage conditions.

    Product
    SOLIRIS — SOLIRIS (ECULIZUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1514-2014·2014-08-13

    Janssen Recalls Risperdal CONSTA Due to Sterility Failure

    Janssen Pharmaceuticals is recalling one lot of Risperdal CONSTA (risperidone) 25 mg dose packs due to a sterility failure detected in a stability sample.

    Product
    RISPERDAL CONSTA — RISPERDAL CONSTA (RISPERIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2296-2014·2014-08-13

    Hot Mama's Foods Recalls Hummus and Dip for Listeria Concerns

    Hot Mama's Foods is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes contamination.

    Product
    Roasted Garlic Hummus sold under the Archer Farms brand and packaged in a transparent plastic tub with a net weight of 17 oz (1 lb. 1 oz).
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1523-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B6 Injection Vials Nationwide

    Medical Supply Liquidators LLC is recalling Vitamin B6 Pyridoxine HCL for Injection because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.

    Product
    Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V500000·2014-08-13

    GM Recalls 2011-2014 Chevrolet Express and GMC Savana CNG Vehicles

    General Motors is recalling 2011-2014 Chevrolet Express and GMC Savana CNG vehicles due to a potential natural gas leak that could cause a fire or explosion.

    Product
    CHEVROLET — CHEVROLET, GMC EXPRESS, SAVANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2290-2014·2014-08-13

    KIND Recalls Multiple Protein Bars Due to Potential Peanut Presence

    KIND, LLC is recalling several Strong & Kind and Kind protein bars nationwide and in Mexico due to the potential presence of peanut protein.

    Product
    STRONG & KIND Honey Smoked BBQ Almond Protein Bar, 45g, packaged in a red, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1531-2014·2014-08-13

    FDA Recalls G.A.C. 375 Injection Due to Unregistered Manufacturer

    The FDA is recalling G.A.C. 375 Injection USP because the manufacturing firm is not registered with the FDA as a drug manufacturer.

    Product
    G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1529-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injection Vials

    Medical Supply Liquidators LLC is recalling Vitamin B12 Hydroxocobalamin Injection vials because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.

    Product
    Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2159-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

    ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.

    Product
    Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1532-2014·2014-08-13

    L-Carnitine Injection Recalled for Lack of FDA Approval and Registration

    Medical Supply Liquidators LLC is recalling L-Carnitine Injection USP 100 mg/ml because it was marketed without an approved NDA/ANDA and the manufacturer is not registered with the FDA.

    Product
    L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1528-2014·2014-08-13

    B Complex Injection Recalled for Lack of FDA Approval

    Medical Supply Liquidators LLC is recalling B Complex for Injection USP with Methylcobalamin because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.

    Product
    B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2293-2014·2014-08-13

    KIND Recalls Multiple Protein Bars Due to Peanut Allergen

    KIND, LLC is recalling several KIND and Strong & KIND bar varieties due to the potential presence of peanut protein.

    Product
    STRONG & KIND Hickory Smoked Almond Protein Bar, 45g, packaged in a grey, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1521-2014·2014-08-13

    BCAA 4% Injection Recalled for Lack of FDA Approval

    Medical Supply Liquidators LLC is recalling BCAA 4% Branched Chain Amino Acid Injection USP because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.

    Product
    BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide