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.

20176–20200 of 32117

  • SevereCPSC·16749·2016-06-01

    Mohu Recalls BeBox Smart Boomboxes Due to Burn and Fire Hazards

    Mohu is recalling about 1,700 BeBox smart boomboxes because they can overheat, posing burn and fire hazards. One incident of a unit catching fire was reported, with no injuries.

    Product
    Boombox
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0890-2016·2016-06-01

    FDA Recalls Bull Capsules Marketed Without FDA Approval

    R Thomas Marketing, LLC is recalling Bull capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·16185·2016-06-01

    Traxxas Recalls X-Maxx Monster Trucks and Speed Controls for Fire Hazard

    Traxxas is recalling X-Maxx Monster Trucks and VXL-6 electronic speed controls because a short circuit can cause a fire. The company reported 40 fires and one injury.

    Product
    X-Maxx Monster Trucks and VXL-6 electronic speed controls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1792-2016·2016-06-01

    American Surgical Delicot X Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Delicot X sponges due to packaging defects that compromise sterility. The recall covers 3 boxes distributed worldwide.

    Product
    American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0861-2016·2016-06-01

    Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 282,080 bags of 0.9% Sodium Chloride Injection USP due to a lack of assurance of sterility caused by potential container leaks.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1284-2016·2016-06-01

    Aloha Medicinals Recalls Organic Dried Mushroom Powder Due to E. coli

    Aloha Medicinals is recalling organic dried mushroom powder after a sample tested positive for E. coli following customer reports of stomach issues.

    Product
    Organic Auricularia auricular (Dried Mushroom Powder (Jelly Ear Mushroom). 60 kg 4 mil polyethylene bags inside plastic polyethylene black drum. Certified Organic by QAI - Made in USA. Aloha Medicinals Inc. 2300 Arrowhead Drive Carson City, NV 89706
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0865-2016·2016-06-01

    Hospira Recalls Sodium Bicarbonate Injection Due to Insect Particulate Matter

    Hospira Inc. is recalling 72,000 units of 8.4% Sodium Bicarbonate Injection because an insect was found in one vial.

    Product
    8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V391000·2016-06-01

    KZRV Recalls 2016 MXT Travel Trailers Due to Underrated Safety Chains

    KZRV is recalling 2016 MXT travel trailers because the safety chains are rated for less weight than the vehicle's gross weight rating, posing a crash risk if the main connection fails.

    Product
    KZRV — KZRV MXT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1378-2016·2016-06-01

    Sausage Maker Seasoning Recalled for Undeclared Milk Allergens

    The Sausage Maker, Inc. is recalling specific seasoning products because they contain undeclared whey protein and skim milk powder.

    Product
    THE SAUSAGE MAKER SEASONING Dried Sticks Hot under the following labels: 1) Net Wt 2 lbs, 2) Net Wt 25 lbs, 3) Hot Dried Sausage Sticks Kit w/19mm
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1381-2016·2016-06-01

    Sausage Maker Seasoning Recalled for Undeclared Milk Ingredients

    The Sausage Maker, Inc. is recalling Summer Sausage seasoning due to undeclared whey protein and skim milk powder.

    Product
    THE SAUSAGE MAKER SEASONING Summer Sausage under the following labels: 1) Net Wt 8 oz, 2) Net Wt 2 lbs. 8 oz., 3 ) Net Wt 25 lbs, 4) Summer Sausage Kit
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0893-2016·2016-06-01

    FDA Recalls African Superman Supplements Marketed Without Approval

    R Thomas Marketing, LLC is recalling African Superman supplements because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0872-2016·2016-06-01

    Sanofi Recalls Auvi-Q Epinephrine Auto-Injectors Due to Defective Delivery System

    Sanofi-Aventis is recalling Auvi-Q epinephrine auto-injectors because a defective delivery system may result in inaccurate dosage delivery.

    Product
    Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0859-2016·2016-06-01

    Teva Recalls Amikacin Sulfate Injection Due to Glass Particulate Matter

    Teva Pharmaceuticals USA is recalling Amikacin Sulfate injection vials because glass particulate matter was identified in one vial.

    Product
    Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1384-2016·2016-06-01

    Unlabeled Dried Yellow Fish Recalled for Being Uneviscerated

    WD Import and Export Inc. is recalling 2 cases of unlabeled, whole dried yellow fish from China found to be uneviscerated.

    Product
    Whole Dried Yellow Fish in bulk cardboard box, unlabeled, Product of China --- Fish measured 6.5 - 7.5 inches in length
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1823-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet, Inc. is recalling specific trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0866-2016·2016-06-01

    Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

    Fresenius Kabi is recalling specific lots of Octreotide Acetate Injection because they failed impurities and degradation specifications.

    Product
    OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0902-2016·2016-06-01

    FDA Recalls Mojo Risen Distributed Without Approved New Drug Application

    R Thomas Marketing, LLC is recalling Mojo Risen capsules nationwide because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0898-2016·2016-06-01

    Happy Passengers Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Happy Passengers capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V385000·2016-05-31

    Winnebago Recalls 2015-2016 Motor Homes for Steering Box Defect

    Winnebago is recalling 2015-2016 Tour and Itasca Ellipse motor homes because a steering box defect could cause loss of steering ability.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA TOUR, ELLIPSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E049000·2016-05-27

    Xperion Recalls CNG Fuel Tanks Due to Leak Risk

    Xperion is recalling specific CNG fuel tanks because a neck adapter may pull out, allowing fuel to leak and increasing fire risk.

    Product
    FUEL SYSTEM, OTHER:STORAGE:TANK ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V373000·2016-05-27

    Jaguar Recalls 2009-2011 XF Models for Air Bag Inflator Rupture Risk

    Jaguar is recalling 2009-2011 XF vehicles in specific states because passenger air bag inflators may rupture during a crash, potentially causing serious injury or death.

    Product
    JAGUAR — JAGUAR XF
    Category
    Vehicle
    Distribution
    Distributed nationwide