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.

14251–14275 of 29192

  • SevereFDA (Drugs)·D-0834-2018·2018-05-30

    Ideaz Recalls Screamin' Hot Pain Gel Due to Benzene Levels

    Ideaz LLC is recalling Screamin' Hot Pain Relieving Gel because it was manufactured with benzene levels exceeding FDA limits.

    Product
    screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0827-2018·2018-05-30

    Fresenius Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Fresenius Medical Care is recalling 25,356 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility.

    Product
    0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1901-2018·2018-05-30

    LivaNova Recalls Sorin Stockert Heater-Cooler Systems Due to Suspected Microbial Contamination

    LivaNova USA is recalling 2,408 Sorin Stockert Heater-Cooler System 3T units because they are suspected of microbial contamination and may contain visible biofilm.

    Product
    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Food)·F-1490-2018·2018-05-30

    Shawnee Milling Recalls Self-Rising Flour for Metal Fragment Risk

    Shawnee Milling Company is recalling 1,350 bags of self-rising flour in four states due to potential metal fragments.

    Product
    Hilltop Hearth Self-Rising Flour, Katy s Kitchen Self-Rising Flour, Springwell A1 Flour all packaged in 50 pound paper bags
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0822-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Cross-Contamination Risk

    Mylan Institutional, Inc. is recalling Loxapine Capsules 25 mg due to cGMP violations that create a risk of cross-contamination.

    Product
    Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V355000·2018-05-30

    Nissan Recalls 2018 Infiniti QX30 for Seat Belt Anchorage Defect

    Nissan is recalling 2018 Infiniti QX30 vehicles because the right-hand lower seat belt anchorage bolt may be incorrectly installed, increasing injury risk in a crash.

    Product
    INFINITI — INFINITI QX30
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1491-2018·2018-05-30

    Flowers Bakery Recalls Hot Dog Buns for Undeclared Milk and Soy

    Flowers Bakery of Montgomery LLC is recalling 155 cases of Hot Dog Buns due to undeclared milk and soy allergens. The product was distributed in Florida, Illinois, Missouri, and Texas.

    Product
    Hot Dog Buns
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1479-2018·2018-05-30

    Morgan Foods Recalls Great Value Gluten Free Tomato Soup for Undeclared Milk

    Morgan Foods, Inc. is voluntarily recalling Great Value Gluten Free Tomato Condensed Soup because it contains undeclared milk, a major allergen.

    Product
    Great Value Gluten Free Tomato Condensed Soup, 10.5 oz, Number 1 Can, Two formats shipped: 8 cans per tray and 12 cans per tray
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·18V351000·2018-05-29

    Western Star 4900 Trucks Recalled for Brake Hose Chafing Risk

    Daimler Trucks North America is recalling 2012-2019 Western Star 4900 trucks because front brake hoses may chafe against the hood, potentially reducing braking effectiveness.

    Product
    WESTERN STAR — WESTERN STAR 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V353000·2018-05-29

    Daimler Trucks Recalls 2017-2019 Models for Brake Caliper Bolt Issue

    Daimler Trucks North America is recalling 8,741 trucks because brake caliper mounting bolts may be insufficiently tightened, potentially reducing braking performance and increasing crash risk.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER, FCCC 5700, 4900, 4700, 108SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V352000·2018-05-29

    Thomas Built Buses Recalling School Buses for Brake Bolt Issue

    Daimler Trucks North America is recalling 2,767 Thomas Built Buses Saf-T-Liner models from 2017-2019 because brake caliper mounting bolts may be insufficiently tightened.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER C2, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V342000·2018-05-27

    GM Recalls 2018 Chevrolet Sonic for Driver Seat-Back Welding Defect

    General Motors is recalling 2018 Chevrolet Sonic vehicles because a joint in the driver's seat-back frame may not be properly welded, which could reduce strength in a crash.

    Product
    CHEVROLET — CHEVROLET SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·041-2018·2018-05-26

    Hormel Recalls Canned Pork and Chicken Products Due to Metal Contamination

    Hormel is recalling specific cans of SPAM and Black-Label Luncheon Loaf because they may contain metal pieces. Consumers should discard or return these products.

    Product
    Hormel Foods Corporation Recalls Canned Pork and Chicken Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V344000·2018-05-25

    Chrysler Recalls 2019 Jeep Cherokee for Engine Component Defects

    Chrysler is recalling 2019 Jeep Cherokee vehicles with 2.0L engines due to missing valve stem keepers or reversed camshaft caps that may cause engine failure and stalling.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V343000·2018-05-25

    2018 Jeep Wrangler Recall for Steering Shaft Weld Defect

    Chrysler is recalling 2018 Jeep Wrangler vehicles because a steering shaft weld may split, potentially causing loss of steering responsiveness and increasing crash risk.

    Product
    JEEP — JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V347000·2018-05-25

    Maserati Recalls 2018 Models Due to Front Sub Frame Weld Defects

    Maserati is recalling 2018 Levante, Ghibli, and Quattroporte vehicles because incomplete front sub frame welds may break, potentially causing loss of vehicle control.

    Product
    MASERATI — MASERATI LEVANTE, GHIBLI, QUATTROPORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V340000·2018-05-24

    GMC Recalls 2018 Terrain Models Due to Air Bag Module Software Defect

    General Motors is recalling 2018 GMC Terrain vehicles because the air bag control module may fail to power down, potentially preventing air bag deployment in a crash.

    Product
    GMC — GMC TERRAIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1842-2018·2018-05-23

    Medtronic Endo GIA Stapler Kits Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA stapler kits worldwide because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 (Item Number: KIT-DE-0083,KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1838-2018·2018-05-23

    COVIDIEN Medtronic Recalls VATS Lobectomy Kits Due to Missing Sled Component

    COVIDIEN Medtronic is recalling 171,271 VATS lobectomy kits because the device may be missing a sled component. This defect can cause failure to form a staple line, leading to bleeding or leakage during surgery.

    Product
    (1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: VATSLOB11, VATSLOB11 ZESTAW DO VATS LOBECTOMII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1848-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
    Category
    Medical Device
    Distribution
    Distributed nationwide