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.

19326–19350 of 32115

  • SevereNHTSA·16V636000·2016-09-02

    Nissan Recalls Maxima and Murano Models Due to Brake Fluid Leak Fire Risk

    Nissan is recalling certain 2015-2017 Maxima and Murano vehicles because brake fluid may leak onto an electrical circuit board, increasing the risk of a fire.

    Product
    NISSAN — NISSAN MAXIMA, MURANO HYBRID, MURANO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V635000·2016-09-01

    Kaufman Recalls 2015-2016 Mini Car Haulers Due to Suspension Defect

    Kaufman Trailers is recalling 285 model year 2015-2016 Mini 5-Car Haulers because a suspension spring eye may break, allowing the axle to slide and increasing crash risk.

    Product
    KAUFMAN — KAUFMAN MINI CAR HAULER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16257·2016-09-01

    Polaris Recalls RZR XP Turbo Vehicles Due to Fire and Burn Hazards

    Polaris is recalling approximately 13,000 RZR XP Turbo recreational off-highway vehicles because engine overheating and loose drain tubes can cause fires and severe burn injuries.

    Product
    Recreational Off-Highway Vehicles (ROVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16T013000·2016-09-01

    Goodyear Recalls G399A LHS Tires Due to Tread Separation Risk

    Goodyear is recalling specific G399A LHS tires due to a manufacturing defect that may cause tread separation, increasing the risk of a crash.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1978-2016·2016-08-31

    SM Fish Corp. Recalls Herring Due to Listeria Contamination Risk

    SM Fish Corp. is recalling Ossie's Taam Shabbos Herring because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S TAAM SHABBOS HERRING, NET WT. 7 OZ., UPC 739885109057; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2358-2016·2016-08-31

    Alere INRatio2 PT/INR Home Monitoring System Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio2 PT/INR Home Monitoring Systems because they may display inaccurate INR results compared to central laboratory tests.

    Product
    Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1989-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Pickled Lox Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Pickled Lox because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S PICKLED LOX, NET WT. 8 OZ., UPC 739885104137; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1980-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Wasabi Herring Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Wasabi Herring because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S WASABI HERRING, NET WT. 7 OZ., UPC 739885109088; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2614-2016·2016-08-31

    Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Fracture

    Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2597-2016·2016-08-31

    Conmed Pediatric ThermoGard Electrodes Recalled for Burn Risk

    Conmed is recalling Pediatric ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.

    Product
    Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator.
    Category
    Medical Device
    Distribution
    45 states
  • SevereFDA (Devices)·Z-2651-2016·2016-08-31

    Medtronic Evera ICDs Recalled for Rapid Battery Depletion Risk

    Medtronic is recalling 78 Evera ICDs and Viva CRT-Ds due to a circuit defect causing rapid battery depletion. Seven confirmed failures have resulted in complications like shortness of breath.

    Product
    Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1977-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Herring in Sourcream Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Herring in Sourcream because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S HERRING IN SOURCREAM, NET WT. 8 OZ., UPC 739885114174; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2356-2016·2016-08-31

    Alere INRatio PT Monitoring Systems Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio PT Monitoring Systems because they may show lower INR results than central laboratory tests, potentially affecting warfarin therapy.

    Product
    Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1988-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Pickled Herring Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Pickled Herring Clear due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S PICKLED HERRING CLEAR, NET WT. 8 OZ., UPC 739885104205; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1468-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1956-2016·2016-08-31

    Northwest Wild Products Recalls Canned Fish Due to Botulism Risk

    Northwest Wild Products is recalling various canned fish products because they may be contaminated with Clostridium botulinum.

    Product
    Wild Steelhead Salmon - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1958-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling various canned seafood products, including sardines, due to potential Clostridium botulinum contamination.

    Product
    Oregon Sardines - Mustard-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1972-2016·2016-08-31

    Eatin' Alive Recalls Thai Wrap and Noodles for Undeclared Soy

    Paige Common dba Eatin' Alive is recalling Thai Peanut Noodles and Thai Wrap because they contain undeclared soy.

    Product
    Eatin' Alive VEGAN GLUTEN FREE RAW thai wrap. Keep Refrigerated. 6oz UPC 0 91037 56620
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2623-2016·2016-08-31

    Cook Inc. Recalls White Lumax Guiding Coaxial Catheters Due to Tip Fracture

    Cook Inc. is recalling 3,425 White Lumax Guiding Coaxial Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2616-2016·2016-08-31

    Cook Inc. Recalls Haskal Transjugular Intrahepatic Portal Access Sets

    Cook Inc. is recalling Haskal Transjugular Intrahepatic Portal Access Sets due to polymer degradation that can cause catheter tip fracture and separation.

    Product
    Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2666-2016·2016-08-31

    Tecan Hydroflex ELISA Plate Washer Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling Hydroflex ELISA plate washers because the batteries may overheat, melt, or char.

    Product
    Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Drugs)·D-1466-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1979-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Stiglitz Herring Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Stiglitz Herring in New York and New Jersey because the manufacturing plant tested positive for Listeria monocytogenes.

    Product
    OSSIE'S STIGLITZ HERRING, NET WT. 7 OZ., UPC 739885109064; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1952-2016·2016-08-31

    Northwest Wild Products Recalls Canned Fish Due to Botulism Risk

    Northwest Wild Products is recalling various canned fish products with codes starting with OC due to potential Clostridium botulinum contamination.

    Product
    Wild Columbia River Coho Salmon- Custom Smoked, NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2610-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters Due to Tip Fracture

    Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide