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.

13176–13200 of 29186

  • SevereNHTSA·18V845000·2018-11-28

    Ford Recalls 2016-2018 Focus Models Due to Clutch Fracture Risk

    Ford is recalling 2016-2018 Focus vehicles with 1.0L engines and manual transmissions because a clutch fracture could cause a fluid leak and fire risk.

    Product
    FORD — FORD FOCUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0272-2019·2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, USP, 300 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0658-2019·2018-11-28

    Elaboraciones Felo Pizza Turnovers Recalled for Undeclared Wheat and Soy Allergens

    Elaboraciones Felo, Inc. is recalling Pizza Turnovers because the products failed to declare wheat and soy allergens. The recall covers 7,011 cases distributed in Puerto Rico.

    Product
    Pizza Turnover, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0698-2019·2018-11-28

    Recchiuti Bittersweet Dark Chocolate Recalled for Undeclared Milk Protein

    Confections by Michael Recchiuti is recalling specific lots of Bittersweet Dark Chocolate because FDA analysis found high levels of milk protein.

    Product
    Recchiuti Bittersweet, Smooth, rich and complex. Net Wt. 3 oz. (85 G) Also sold in case of 12 UPC 8019895 00017 6 Ingredient: Dark chocolate {cocoa beans, sugar, cocoa butter, soy lecithin (emulsifier)} Natural vanilla extract, cacao paste. Contains: soy Made on…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0265-2019·2018-11-28

    Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity

    Golden State Medical Supply is recalling 12,502 bottles of Irbesartan 300 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).

    Product
    IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·18E109000·2018-11-28

    TSE Brakes Recalls Air Brake Actuators Due to Washer Fracture Risk

    TSE Brakes is recalling specific Air Brake Actuators because mounting washers may fracture, potentially reducing braking ability and increasing crash risk.

    Product
    SERVICE BRAKES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0488-2019·2018-11-28

    Sedecal NOVA FA DR System Recalled for Potential Cable Failure

    Sedecal S.A. is recalling 145 NOVA FA DR diagnostic radiography systems because installation or maintenance issues could cause support cables to break, leading to equipment falling.

    Product
    Sedecal NOVA FA DR System. for diagnostic radiography.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0263-2019·2018-11-28

    FDA Recalls Irbesartan Tablets Due to NDEA Impurity

    Golden State Medical Supply Inc. is recalling 2,439 bottles of Irbesartan 75 mg tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90.
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·18V841000·2018-11-28

    Porsche Recalls 2018 Panamera Hybrid Models for Brake Line Corrosion

    Porsche is recalling 2018 Panamera Hybrid models because front brake lines may corrode, potentially reducing braking performance and increasing crash risk.

    Product
    PORSCHE — PORSCHE PANAMERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0267-2019·2018-11-28

    Sciegen Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling Westminister Irbesartan Tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0649-2019·2018-11-28

    Bazzini Pistachios Recalled Due to Salmonella Contamination

    Bazzini LLC is recalling 4,000 lbs of roasted and salted in-shell pistachios because the product tested positive for Salmonella.

    Product
    BAZZINI S ROASTED & SALTED IN-SHELL PISTACHIOS SUPER COLOSSAL NATURAL 5 LBS BAG UPC #0 75062 30701 5 THE BAGS ARE RED, WHITE AND BLUE.
    Category
    Food
    Distribution
    12 states
  • SevereNHTSA·18V843000·2018-11-28

    Keystone RV Recalls 2019 Travel Trailers Due to Axle Hub Bearing Defect

    Keystone RV Company is recalling certain 2019 recreational trailers because the inner axle hub bearings may not have been sufficiently greased, which could cause overheating, hub failure, and increased crash risk.

    Product
    KEYSTONE — KEYSTONE, DUTCHMEN OUTBACK, BULLET, AEROLITE, PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0264-2019·2018-11-28

    Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity

    Golden State Medical Supply is recalling Irbesartan 150 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).

    Product
    IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·18V846000·2018-11-28

    Blue Bird Recalls School Buses Due to Seat Detachment Risk

    Blue Bird is recalling certain 2019-2020 school buses because seats may detach from the floor in a crash, increasing injury risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, VISION, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0268-2019·2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling Irbesartan Tablets, 150 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0478-2019·2018-11-28

    Voluntis Recalls Insulia Diabetes Management Companion Due to Calculator Bug

    Voluntis is recalling the Insulia Diabetes Management Companion because a bug in the Android basal calculator could cause hypoglycemia. An update is available to resolve the issue.

    Product
    Insulia Diabetes Management Companion
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0474-2019·2018-11-28

    Boston Scientific Recalls SQ-RX Pulse Generators for Battery Malfunctions

    Boston Scientific is recalling 12,900 SQ-RX Pulse Generators used in S-ICD systems due to latent internal battery malfunctions that cause accelerated depletion.

    Product
    The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V848000·2018-11-28

    Honda Recalls 2019 Ridgeline and Pilot for Air Bag Deployment Risk

    Honda is recalling 2019 Ridgeline and Pilot vehicles because a trim panel clip may interfere with right-side curtain air bag deployment in a crash.

    Product
    HONDA — HONDA RIDGELINE, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V836000·2018-11-27

    Audi Recalls A5 and A4 Allroad for Passenger Air Bag Defect

    Volkswagen Group of America is recalling 2018 Audi A5 Sportback and 2017-2018 Audi A4 Allroad vehicles because a passenger air bag mounting screw may not be sufficiently tightened.

    Product
    AUDI — AUDI A5, A4 ALLROAD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V839000·2018-11-27

    Mercedes-Benz Recalls 2019 Models for Seat Belt Pre-Tensioner Defect

    Mercedes-Benz is recalling 4,969 2019 vehicles because seat belt pre-tensioners may not activate in a crash, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES-MAYBACH E 450, S 450, C 300, S 560 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V840000·2018-11-27

    Mercedes-Benz Recalls 2019 GLC 300 for Steering Assist Failure

    Mercedes-Benz is recalling 2019 GLC 300 vehicles because a steering sensor may fail, deactivating power assist and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLC 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V832000·2018-11-26

    Airstream Recalls 2019 Interstate Motorhomes Due to Fuse Defect

    Airstream is recalling 2019 Interstate motorhomes because incorrect fuses may allow battery cables to overheat, increasing fire risk.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V830000·2018-11-26

    BMW Recalls One 2019 F850GS Motorcycle for Engine Defect

    BMW is recalling one 2019 F850GS motorcycle because engine connecting rods may be loose, risking engine damage and loss of power.

    Product
    BMW — BMW F850GS
    Category
    Vehicle
    Distribution
    Distributed nationwide