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.

14826–14850 of 29202

  • SevereFDA (Drugs)·D-0423-2018·2018-02-21

    PharMEDium Recalls Ropivacaine Cassettes Due to Sterility Assurance Failure

    PharMEDium Services, LLC is recalling 21 cassettes of 0.2% Ropivacaine HCI due to a failure to follow proper testing procedures, raising concerns about sterility and endotoxin levels.

    Product
    0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0381-2018·2018-02-21

    Sage Products Recalls Toothette Oral Care Suction Swab System

    Sage Products Inc. is recalling Toothette Oral Care Suction Swab Systems due to cross-contamination with non-pharmaceutical products during manufacturing.

    Product
    Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium, bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 2 Packages of 1 Suction Toothbrush with sodium bicarbonate and a .25 fl oz/7ml pouch of…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0364-2018·2018-02-21

    Sage Products Recalls Toothette Oral Care Systems Due to Cross-Contamination

    Sage Products is recalling Toothette Oral Care Single Use Systems because they were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Toothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml tube of Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6012 UPC (01)00618029800077
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0368-2018·2018-02-21

    Sage Products Recalls Toothette Oral Care Suction Swab System

    Sage Products Inc. is recalling the Toothette Oral Care Suction Swab System due to cross-contamination with non-pharmaceutical products during manufacturing.

    Product
    Toothette Oral Care Suction Swab System With Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Suction Swabs with sodium bicarbonate 0.25 fl oz/7ml Antiseptic Oral Rinse 0.7 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Roarald, Cary, IL 60013. Product Code…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0344-2018·2018-02-21

    FDA Recalls Unapproved Limbrel Flavocoxid Capsules Nationwide

    Primus Pharmaceuticals is recalling 7,826 bottles of Limbrel (flavocoxid 250 mg) capsules because the product was marketed without an approved NDA or ANDA.

    Product
    Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-601-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0365-2018·2018-02-21

    Sage Products Recalls Toothette Oral Care Systems Due to Cross-Contamination

    Sage Products Inc. is recalling Toothette Oral Care Single Use Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.

    Product
    Toothette Oral Care Single Use System with Perox-A-Mint solution and Mouth Moisturizer. Contains 2 Toothette Plus Swabs with sodium bicarbonate, .25 fl oz/7ml Perox-A-Mint solution and .07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0377-2018·2018-02-21

    Sage Products Recalls Q CARE Oral Cleansing Systems Due to Cross-Contamination

    Sage Products Inc. is recalling Q CARE q4 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0378-2018·2018-02-21

    Sage Products Recalls Oral Cleaning Systems Due to Cross-Contamination

    Sage Products Inc. is recalling 852 cases of Oral Cleaning and Suctioning System q2 because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untreated Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint- solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash solution, 2 Oropharyngeal…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0393-2018·2018-02-21

    Sage Q.Care Oral System Recalled for Cross-Contamination Risk

    Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Petit Size Suction Toothbrush packages with Antiseptic Oral Rinse, 4 Petit Size Untreated Suction Oral Swab packages with Antiseptic Oral Rinse, 2 8 French…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0405-2018·2018-02-21

    Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination Risk

    Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2018·2018-02-21

    Sage Products Recalls Oral Cleansing Systems Due to Cross-Contamination Risk

    Sage Products Inc. is recalling 2,199 cases of Oral Cleansing & Suctioning System q4 because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, 2 Untreated Suctino Toothbrush packages with Antiplaque solution, 4)Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V126000·2018-02-20

    Kaufman Double Deck Car Hauler Recalled for Axle Spindle Defect

    Kaufman is recalling 2018 Double Deck Car Hauler trailers because incorrect axle spindles may fail, causing wheel detachment and increasing crash risk.

    Product
    KAUFMAN — KAUFMAN DOUBLE DECK CAR HAULER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·012-2018·2018-02-20

    Night Hawk Recalls Frozen Beef Patties for Undeclared Milk Allergen

    Night Hawk Frozen Foods is recalling approximately 167 pounds of frozen beef patty and gravy products because they contain undeclared milk, a known allergen.

    Product
    Night Hawk Frozen Foods, Inc. — Night Hawk Frozen Foods, Inc. Recalls Frozen Beef Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·18V114000·2018-02-19

    Karma Revero Recalled for Side Air Bag Detachment Risk

    Karma Automotive is recalling 2018 Revero vehicles because side curtain air bags may partially detach during deployment, increasing injury risk in a crash.

    Product
    KARMA — KARMA REVERO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V119000·2018-02-19

    Hino Recalls 2018-2019 Trucks Due to Loose Fuse Terminal Bolts

    Hino is recalling 2018-2019 NE8J, NH8J, NJ8J, and NV8J trucks because loose fuse terminal bolts may cause electrical arcing, overheating, or engine shutdown.

    Product
    HINO — HINO NE8J, NH8J, NJ8J, NV8J
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V121000·2018-02-19

    Keystone Recalls 2018 Crossroads Trailers Due to Electrical Fire Risk

    Keystone RV is recalling 2018 Crossroads Zinger and Longhorn trailers because an improperly installed ground wire may cause an electrical short and fire.

    Product
    CROSSROADS — CROSSROADS LONGHORN, ZINGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V118000·2018-02-17

    Hyundai Recalls 2018 Santa Fe Vehicles Due to Steering Wheel Defect

    Hyundai is recalling 2018 Santa Fe and Santa Fe Sport vehicles because the steering wheel assembly may break and separate from the column while driving.

    Product
    HYUNDAI — HYUNDAI SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·011-2018·2018-02-16

    Pilgrim's Pride Recalls Breaded Chicken Patties Due to Rubber Contamination

    Pilgrim's Pride is recalling ready-to-eat breaded chicken patties that may contain rubber. The recall affects approximately 101,310 pounds shipped to institutions nationwide.

    Product
    Pilgrim's Pride Corporation — Pilgrim's Pride Corporation Recalls Ready-to-Eat Chicken Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V116000·2018-02-16

    Freightliner MT45G and MT55G Recalled for Electrical Fire Risk

    Daimler Trucks North America is recalling 2018 Freightliner MT45G and MT55G vehicles because a capacitor bracket may cause an electrical short, increasing the risk of fire.

    Product
    FREIGHTLINER — FREIGHTLINER MT55G, MT45G
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18100·2018-02-15

    Rural King Recalls Electric Blankets and Throws Due to Fire and Burn Hazards

    Rural King is recalling electric heated blankets and throws because the cords can overheat, posing fire and burn risks. Consumers should stop using the products and contact the company for a refund.

    Product
    Electric heated blankets and throws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0702-2018·2018-02-14

    Frog Holler Recalls Cherry Tomatoes for Potential Salmonella Contamination

    Frog Holler Ltd. is voluntarily recalling cherry tomatoes in pint clamshells due to potential Salmonella contamination. The product was distributed in Michigan between January 4 and 10, 2018.

    Product
    Cherry Tomatoes, packaged in a pint sized plastic clamshell, no labeling
    Category
    Food
    Distribution
    1 state