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.

13151–13175 of 29186

  • SevereFDA (Devices)·Z-0506-2019·2018-12-05

    NxStage PureFlow B Solution Recalled Due to Bag Bursting Risk

    NxStage Medical is recalling 7,275 units of PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0470-2019·2018-12-05

    Synaptive Medical Recalls BrightMatter Guide Software Due to Defect

    Synaptive Medical Inc is recalling 37 units of BrightMatter Guide software due to a defect that occurs when switching between specific port trajectories during surgery.

    Product
    BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V862000·2018-12-05

    Audi Recalls 2015-2016 A6 and A7 Models for Fire Risk

    Volkswagen is recalling 2015-2016 Audi A6 and 2015 A7 vehicles because an incorrectly inserted auxiliary heater connector may overheat and cause a fire.

    Product
    AUDI — AUDI A7, A6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0359-2019·2018-12-05

    Sandoz Losartan Potassium and Hydrochlorothiazide Tablets Recalled for NDEA Impurity

    Sandoz is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0437-2019·2018-12-05

    Maquet Cardiovascular Recalls QUADROX-i Neonatal Membrane Oxygenators

    Maquet Cardiovascular is recalling QUADROX-i Neonatal membrane oxygenators due to a potential for blood leakage at the blood inlet connector when using a specific reducing screw adapter.

    Product
    QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0502-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting and Injury

    NxStage Medical is recalling specific lots of PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0505-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting

    NxStage Medical is recalling PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V863000·2018-12-05

    Volkswagen Recalls 2018 Audi Models for Fuel Hose Fire Risk

    Volkswagen is recalling 2018 Audi A3 and TT models because a fuel hose connector may detach, causing a leak that increases fire risk.

    Product
    AUDI — AUDI A3 CABRIOLET, TT ROADSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V859000·2018-12-04

    Newmar Recalls 2018-2019 Motorhomes Due to Loose Brake Caliper Bolts

    Newmar is recalling 2018-2019 Essex, Ventana, and London Aire motorhomes because brake caliper mounting bolts may be loose, increasing crash risk.

    Product
    NEWMAR — NEWMAR VENTANA LE, VENTANA, ESSEX, LONDON AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·085-2018 EXP·2018-12-04

    JBS Tolleson Recalls Raw Beef Products Due to Salmonella Newport

    JBS Tolleson is recalling approximately 12.1 million pounds of raw beef products, including ground beef, due to possible Salmonella Newport contamination.

    Product
    JBS Tolleson Inc. — JBS Tolleson, Inc. Recalls Raw Beef Products due to Possible Salmonella Newport Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V857000·2018-12-03

    Gulf Stream Vintage Cruiser Recalled for Insufficient Bearing Grease

    Gulf Stream is recalling 2019 Vintage Cruiser recreational trailers because inner hub bearings may lack sufficient grease, risking overheating and hub failure.

    Product
    GULF STREAM — GULF STREAM VINTAGE CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V858000·2018-12-03

    McNeilus and Oshkosh Trucks Recalled for CNG Valve Defect

    McNeilus is recalling 2016-2018 trucks and Oshkosh S-Series vehicles because a CNG fuel tank valve stem may eject, posing injury and fire risks.

    Product
    MCNEILUS — MCNEILUS, OSHKOSH XE REAR LOADER, STANDARD MIXER, BRIDGEMASTER V MIXER, MERIDIAN FRONT LOADER 78
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E111000·2018-12-01

    Luxfer Recalls One-Turn Valves Due to Potential Stem Ejection Risk

    Luxfer Canada Ltd. is recalling One-Turn Valves (part number MPVE-250) because the valve stem may forcibly eject if the knob is turned more than one turn, posing injury and fire risks.

    Product
    FUEL SYSTEM, OTHER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V853000·2018-11-30

    Keystone Recalls 2019 Montana Trailers Due to Axle Weld Defects

    Keystone RV Company is recalling 2019 Montana recreational trailers because defective axle welds could cause the wheel assembly to detach, increasing crash risk.

    Product
    KEYSTONE — KEYSTONE MONTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V850000·2018-11-29

    Mercedes-Benz Recalls Vehicles Due to Steering Rack Locknut Failure Risk

    Mercedes-Benz is recalling specific 2015-2019 models because a steering rack locknut may break, causing the steering to stick and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C 350 E, E 300, C 300, CLS 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0269-2019·2018-11-28

    Sciegen Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling Irbesartan 300mg tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0653-2019·2018-11-28

    Bazzini Pistachios Recalled Due to Salmonella Contamination

    Bazzini LLC is recalling specific lots of roasted and salted in-shell pistachios because the product tested positive for Salmonella.

    Product
    BAZZINI S ROASTED & SALTED IN-SHELL PISTACHIOS COLOSSAL NATURAL 16 OZ BAG UPC #0 75062 00535 5 THE BAGS ARE RED, WHITE AND BLUE.
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0270-2019·2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 75 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V847000·2018-11-28

    Altec Recalls 2017 Aerial Devices Due to Pedestal Fastener Defect

    Altec is recalling 2017 AT37, AT41, and AT48 aerial devices because loose or missing fasteners may cause the pedestal to separate, increasing injury risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0699-2019·2018-11-28

    Recchiuti Dairy-Free Dark Chocolate Recalled for Undeclared Milk Protein

    Confections by Michael Recchiuti is recalling specific lots of Recchiuti Feve Dark Chocolate because FDA analysis found high levels of milk protein in the dairy-free product.

    Product
    Recchiuti Feve. Net Wt. 3 oz. (85 G) Ingredient: Dark chocolate {cocoa beans, sugar, cocoa butter, soy lecithin (emulsifier)} Natural vanilla extract, cacao paste, cacao nibs.. Contains: soy Made on equipment also shared with soy, milk, wheat, eggs, peanuts and tree…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0271-2019·2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

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

    Product
    GSMS 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 ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
    Category
    Drug
    Distribution
    Distributed nationwide