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.

13851–13875 of 29188

  • SevereFDA (Drugs)·D-1039-2018·2018-08-15

    NuCare Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    NuCare Pharmaceuticals is recalling Valsartan/HCTZ 320/25mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2734-2018·2018-08-15

    Waterpik Sonic-Fusion Professional Recall Due to Charging Base Overheating

    Water Pik, Inc. is recalling 3,797 Waterpik Sonic-Fusion Professional units because the charging base may overheat, melt, or spark, posing fire, shock, or burn risks.

    Product
    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1053-2018·2018-08-15

    Guardian Pharmacy Recalls Ascorbic Acid TPN Bags Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 5,000 bags of Ascorbic Acid 500 mg/mL TPN in Texas due to lack of sterility assurance.

    Product
    Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1072-2018·2018-08-15

    Guardian Pharmacy Recalls MIC B Combo Lipotropic Vials for Sterility Concerns

    Guardian Pharmacy Services is recalling 250 vials of MIC B Combo Lipotropic in Texas due to a lack of sterility assurance.

    Product
    MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereCPSC·18205·2018-08-15

    Xtava Recalls Allure Hair Dryers Due to Fire and Burn Hazards

    Xtava is recalling approximately 235,000 Allure and Allure Pro hair dryers because the units and power cords can overheat, catch fire, or cause electrical shock.

    Product
    Allure and Allure Pro hair dryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1126-2018·2018-08-15

    World Organix Recalls Kratom and CBD Capsules for Microbial Contamination

    World Organix LLC is recalling Blissful Remedies Kratom+CBD capsules due to potential high microbial loads. The affected products were distributed nationwide.

    Product
    Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organix LLC, Las Vegas Nevada UPC# 7 11583 27057 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2690-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 269 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2717-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 133 rHead Recon Stem Implants because the revision rate is higher than other similar devices, potentially affecting post-surgery performance.

    Product
    rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2703-2018·2018-08-15

    Howmedica Recalls rHead Radial Head Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 33 rHead Standard Extended Stem implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1761-2018·2018-08-15

    Kraft Heinz Recalls Taco Bell Salsa Con Queso Due to Botulism Risk

    Kraft Heinz is recalling Taco Bell Salsa Con Queso Mild jars nationwide due to a risk of Clostridium botulinum growth.

    Product
    Taco Bell Salsa Con Queso Mild 15oz retail jar UPC 21000024490 packaged in 12 count and 8 count cases
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2721-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 118 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1048-2018·2018-08-15

    Longbow Recalls Emergency First Aid Eyewash Due to Manufacturing Deviations

    Longbow First Aid Products Manufactory is recalling 30,000 bottles of Emergency First Aid Eyewash due to CGMP deviations. The product was distributed in New York and California.

    Product
    Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1057-2018·2018-08-15

    Guardian Pharmacy Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 100 syringes of compounded Glycopyrrolate 0.2 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2725-2018·2018-08-15

    Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 256 radial stem implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V538000·2018-08-15

    Spartan K2 Chassis Recalled for Park Brake Defect

    Spartan Motors is recalling 2018-2019 K2 vehicles because the park brake may fail to hold the vehicle on a grade, increasing crash risk.

    Product
    SPARTAN — SPARTAN K2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V529000·2018-08-13

    Roadtrek Zion Motorhomes Recalled for Rear Brake Line Damage Risk

    Erwin Hymer is recalling 2015-2018 Roadtrek Zion motorhomes because sofa installation may have damaged the rear brake line, increasing stopping distance and crash risk.

    Product
    ROADTREK — ROADTREK ZION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V528000·2018-08-13

    Roadtrek Motorhomes Recalled for Potential Diesel Fuel Tank Damage

    Erwin Hymer is recalling 2017-2018 Roadtrek motorhomes because the diesel fuel tank may have been damaged during seat installation, increasing fire risk.

    Product
    ROADTREK — ROADTREK E-TREK, RS ADVENTUROUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E081000·2018-08-10

    Cummins Recalls Diesel Engines Due to Fuel Line Burst Risk

    Cummins is recalling ISX15 and X15 diesel engines because a restricted fuel pump screen can cause the nylon fuel line to burst, leading to fuel leaks or engine stalling.

    Product
    FUEL SYSTEM, OTHER:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V526000·2018-08-10

    KZRV Sportsmen Travel Trailers Recalled for Propane Line Fire Risk

    KZRV is recalling 2018-2019 Sportsmen 333BHK travel trailers because liquid propane lines routed through the wheel well may be damaged by road debris, increasing fire risk.

    Product
    KZRV — KZRV SPORTSMEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E080000·2018-08-09

    TRW Recalls Outer Tie Rods for Loss of Steering Risk

    TRW is recalling specific outer tie rods sold as replacement parts for 1988-2000 GM vehicles because the locking nut may fail, causing a loss of steering.

    Product
    STEERING:LINKAGES:TIE ROD ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V525000·2018-08-09

    Freightliner Trucks Recalled for Insufficiently Tightened Brake Caliper Bolts

    Daimler Trucks North America is recalling 2018-2019 Freightliner trucks because brake caliper mounting bolts may be loose, which can reduce braking effectiveness and increase crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER 108SD, 114SD, CASCADIA, 122SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V523000·2018-08-09

    Chrysler Recalls 2018-2019 Vehicles for Rear Brake Caliper Coating Defect

    Chrysler is recalling specific 2018-2019 Dodge and Jeep vehicles because rear brake caliper pistons may have insufficient coating, potentially reducing braking performance.

    Product
    DODGE — DODGE, JEEP GRAND CARAVAN, CHEROKEE, JOURNEY, COMPASS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2601-2018·2018-08-08

    Polysorb Suture Recalled for Potential Propylene Glycol Contamination

    Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential propylene glycol contamination. The recall affects 972 units distributed in California, New York, and Texas.

    Product
    Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1022-2018·2018-08-08

    Valsartan tablets recalled due to carcinogen impurity in active ingredient

    H.J. Harkins Co. is recalling Valsartan tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the product.

    Product
    Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
    Category
    Drug
    Distribution
    0 states