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.

24126–24150 of 32184

  • SevereUSDA FSIS·002-2015·2015-01-07

    Nijiya Market Recalls Frozen Boneless Beef Imported Without Inspection

    Nijiya Market is recalling approximately 359 pounds of frozen boneless beef products produced in Japan that were not presented for USDA inspection at the U.S. point of entry.

    Product
    California Firm Recalls Boneless Beef Products Imported Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V002000·2015-01-07

    Polaris Recalls Victory Motorcycles Due to Fuel Pump Defect

    Polaris is recalling certain Victory motorcycles because a manufacturing defect may cause the fuel pump to seize, leading to stalling and an increased risk of a crash.

    Product
    VICTORY — VICTORY HAMMER EIGHT BALL, CROSS ROADS, HIGH BALL, VEGAS EIGHT BALL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·001-2015·2015-01-02

    Texas Firm Recalls Australian Lamb Products Imported Without Inspection

    AMD Imports Inc. is recalling approximately 35,275 pounds of Australian lamb products because they were not presented for USDA inspection at the U.S. point of entry.

    Product
    Texas Firm Recalls Lamb Products Imported Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0868-2015·2014-12-31

    Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk

    Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes because the cuff inflation line may detach during use.

    Product
    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0310-2015·2014-12-31

    Vann Healthcare Recalls Epinephrine Syringes Due to Sterility Concerns

    Vann Healthcare Services is recalling 410 epinephrine syringes because an FDA inspection found deficiencies that raise concerns about the pharmacy's ability to assure sterility.

    Product
    Epinephrine 1:1000, 0.15 mL packaged in 0.3 mL syringes, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0585-2015·2014-12-31

    Heart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs

    Heart Sync, Inc. is recalling Adult Radiotranslucent Electrodes because they do not connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.

    Product
    ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0867-2015·2014-12-31

    Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk

    Halyard Health is recalling KimVent Microcuff Endotracheal Tubes because the cuff inflation line may detach during use, potentially compromising airway management.

    Product
    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0315-2015·2014-12-31

    New Life Nutritional Recalls Super Fat Burner for Undeclared Drugs

    New Life Nutritional Center is recalling Super Fat Burner and other products because they contain undeclared and unapproved drugs.

    Product
    New Life Nutritional SUPER FAT BURNER, bottle contains 30 CAPSULES, product is packaged in a white plastic bottle with black, red and green font. Distributed by: New Life Nutritional under the following addresses: 714 West 181st Street New York, NY 10033, 153 East 188th Street…
    Category
    Drug
    Distribution
    6 states
  • SevereNHTSA·14V830000·2014-12-31

    Subaru Recalls Brake Line Corrosion in Impreza, WRX, and Forester Models

    Subaru is recalling specific Impreza, WRX, STI, and Forester vehicles to fix brake line corrosion that could cause fluid leaks and increased stopping distances.

    Product
    SUBARU — SUBARU WRX, FORESTER, IMPREZA, WRX STI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0587-2015·2014-12-31

    Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs

    Heart Sync, Inc. is recalling multi-function defibrillation electrodes that do not connect with Philips FR3 or FRx AED units, potentially preventing proper device operation.

    Product
    ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0584-2015·2014-12-31

    Heart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs

    Heart Sync, Inc. is recalling Adult/Child Radiotransparent Electrodes because they do not connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.

    Product
    ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0324-2015·2014-12-31

    Hospira Recalls Heparin Sodium Injection Due to Human Hair Particulate

    Hospira is recalling 63,378 units of Heparin Sodium injection because human hair was found sealed inside the container's administration port.

    Product
    HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·093-2014·2014-12-31

    Campos Foods Recalls Chicken Products Due to Undeclared Peanuts

    Campos Foods is recalling approximately 5,300 pounds of chicken products because they contain undeclared peanuts, a known allergen.

    Product
    Tennessee Firm Recalls Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0317-2015·2014-12-31

    New Life Nutritional Recalls Esmeralda and Other Supplements for Undeclared Drugs

    New Life Nutritional Center is recalling Esmeralda, Super Fat Burner, and Maxi Gold Weight Loss Pill due to undeclared and unapproved drugs.

    Product
    Esmeralda, bottle contains 30 Softgels, product is packaged in a white plastic bottle with green labeling and black font. Distributed by: New Life Nutritional, www.newlifenutritional.com under the following addresses: 714 West 181st Street NY, NY 10033, 200-9 Dyckman Street NY…
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0865-2015·2014-12-31

    Halyard KimVent Endotracheal Tubes Recalled for Cuff Line Detachment Risk

    Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes because the cuff inflation line may detach during use.

    Product
    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0872-2015·2014-12-31

    Invacare PerfectO2 Oxygen Concentrator Capacitor Recall for Fire Hazard

    Invacare is recalling Dianz Capacitors used in PerfectO2 Oxygen Concentrators because they may rupture and cause a fire.

    Product
    Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0869-2015·2014-12-31

    Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk

    Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes because the cuff inflation line may detach during use.

    Product
    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0866-2015·2014-12-31

    Halyard KimVent Endotracheal Tubes Recalled for Cuff Line Detachment

    Halyard Health is recalling KimVent Microcuff Endotracheal Tubes because the cuff inflation line may detach from the tube during use.

    Product
    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0312-2015·2014-12-31

    Vann Healthcare Pharmacy Recalls Tri-mix #4 Due to Sterility Concerns

    Vann Healthcare Pharmacy is recalling Tri-mix #4 vials because an FDA inspection found deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility.

    Product
    Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0583-2015·2014-12-31

    Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs

    Heart Sync, Inc. is recalling Adult Radiotransparent Electrodes that fail to connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.

    Product
    ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0753-2015·2014-12-31

    HyVee Cheddar Cheese Stuffed Jalapenos Recalled for Undeclared Egg

    Great American Appetizers, Inc. is recalling HyVee Cheddar Cheese Stuffed Jalapenos due to undeclared egg. The product was distributed in Iowa.

    Product
    HyVee Cheddar Cheese Stuffed Jalapenos. Product is breaded jalapeno stuffed with cheddar cheese designed to be cooked in either the oven or a fryer. The package contains a clear inner plastic sealed bag with the food product, inside a cardboard larger carton. The net weight is 8…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0848-2015·2014-12-31

    Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides Due to Biased Results

    Ortho-Clinical Diagnostics is recalling specific VITROS TRIG slides due to a potential for biased test results. The recall affects 380 units in the US and 155 units internationally.

    Product
    VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0311-2015·2014-12-31

    Vann Healthcare Recalls Lidocaine Syringes Due to Sterility Concerns

    Vann Healthcare Services is recalling Lidocaine 4% syringes because an FDA inspection found deficiencies in the facility's ability to assure sterility.

    Product
    Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0316-2015·2014-12-31

    New Life Nutritional Center Recalls Weight Loss Pills for Undeclared Drugs

    New Life Nutritional Center is recalling specific weight loss and dietary supplement products because they contain undeclared and unapproved drugs.

    Product
    MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged in a clear plastic bottle with blue lid, gold and orange label with orange font. Distributed by: New Life nutritional, www.newlifenutritional.com under the following telephone numbers: (212) 923-6386…
    Category
    Drug
    Distribution
    6 states