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.

14601–14625 of 29192

  • SevereFDA (Devices)·Z-1247-2018·2018-04-04

    Stryker Recalls 11g Verteport Cement Cannula Due to Sterility Concerns

    Stryker is recalling 11g Verteport Cement Cannulas because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1260-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 93 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0954-2018·2018-04-04

    Taylor Farms Recalls Diced Yellow Onions Due to Salmonella Risk

    Taylor Farms is recalling diced yellow onions after routine testing confirmed a positive result for Salmonella. The product was distributed to food service locations in 11 states.

    Product
    Taylor Farms 3/8" Diced Yellow Onion 4/5# bags - 20 lb, corrugated paper carton; 20 lb. box for food service distribution. Item number 1130025; Taylor Farms California Foodservice; Salinas, CA
    Category
    Food
    Distribution
    11 states
  • SevereNHTSA·18V213000·2018-04-04

    Ford Recalls 2017-2018 Vehicles for Missing Transmission Roll Pin

    Ford is recalling 2017-2018 F-150, Expedition, Mustang, and Navigator vehicles because a missing transmission roll pin may cause the vehicle to roll away from Park.

    Product
    LINCOLN — LINCOLN, FORD NAVIGATOR, MUSTANG, EXPEDITION, F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0978-2018·2018-04-04

    Piggie Park Recalls Honey BBQ Sauces Due to Undeclared Soy and Wheat

    Piggie Park Enterprises Inc. is recalling Maurice's Honey Southern Gold BBQ Sauce and Carolina Gold Honey Sauce because they contain undeclared soy and wheat ingredients.

    Product
    Maurice's Honey Southern Gold BBQ Sauce; Net Wt. 18 oz. bottles; UPC Code 0 7561654332 6 and Carolina Gold Honey Sauce; Net Wt. 18 oz. bottle; UPC Code 0 7561654383 8
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0614-2018·2018-04-04

    Apollo Care Recalls Vancomycin IV Bags Due to Unsupported Expiry Date

    Apollo Care is recalling 144 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.

    Product
    Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0953-2018·2018-04-04

    Oregon Wild Berries Recalls Chef Edwin's Mushroom Condensed Soup

    Oregon Wild Berries, Inc. is recalling Chef Edwin's Mushroom Condensed Soup because the product was under-processed or the venting schedule was not followed.

    Product
    Mushroom Condensed Soup, brand Chef Edwin's, packaged in glass pint Kerr jars, Net wt. 14 oz. UPC 7 00424 66845 8. The product label is read in parts: "***Chef Edwin's *** Mushroom Condensed Soup***Oregon Wild Berries Inc. 77129 Watach Dr., Clatskanie, OR 97016***".
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1244-2018·2018-04-04

    Stryker Recalls 180-Gram Cement Cartridges Due to Sterility Assurance Issues

    Stryker is recalling 708 units of 180-Gram Cement Cartridges with Breakaway Femoral Nozzles because bioburden levels were found to be higher than internal acceptable rates.

    Product
    180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1243-2018·2018-04-04

    Stryker Recalls Break-Away Femoral Nozzles Due to Sterility Concerns

    Stryker is recalling 384 Break-Away Femoral Nozzles because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.

    Product
    Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-0969-2018·2018-04-04

    Wegmans Avocado Summer Roll Recalled for Undeclared Egg Allergen

    Wegmans is recalling Avocado Summer Rolls packaged with Thai Sweet Chili Sauce because the sauce contains undeclared egg.

    Product
    Wegmans Avocado Summer Roll, 2 Pack, 5 oz. UPC: 2-48762-00000 or 2-48920-00000 packaged with Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC 7-66630-98023)
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1175-2018·2018-04-04

    ConMed Mini Infant Radiotranslucent Electrodes Recalled for Adhesive Conductivity Issues

    ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0968-2018·2018-04-04

    Wegmans Thai Sweet Chili Sauce Recalled for Undeclared Egg

    Wegmans is recalling Thai Sweet Chili Sauce cups because they contain undeclared egg, a major food allergen.

    Product
    Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC 7-66630-98023)
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·18V214000·2018-04-04

    Ford Recalls 2018 F-Series and Expedition for Gear Shift Cable Defect

    Ford is recalling 2018 F-650, F-750, F-150, and Expedition vehicles because a gear shift cable clip may not be seated, causing the transmission to be in a different gear than indicated.

    Product
    FORD — FORD EXPEDITION, F-150, F-750 SD, F-650 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V215000·2018-04-04

    Zero Motorcycles Recalls 2012 Models Due to Battery Fire Risk

    Zero Motorcycles is recalling 2012 S, DS, and DSP models because battery wear may cause electrical shorts and fire. Owners should stop riding and charging these vehicles.

    Product
    ZERO — ZERO ZERO S, ZERO DS, DSP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1236-2018·2018-04-04

    Zimmer Biomet Recalls Phoenix Nail System Inserter Connectors Due to Fracturing

    Zimmer Biomet is recalling specific lots of Phoenix Nail System 3.5mm Inserter Connectors because they have fractured and remained in the device implant.

    Product
    Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0610-2018·2018-04-04

    Amneal Recalls Fosphenytoin Sodium Injection Due to Particulate Matter

    Amneal Pharmaceuticals is recalling specific lots of Fosphenytoin Sodium Injection because of the presence of particulate matter.

    Product
    Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0972-2018·2018-04-04

    Lancaster Fine Foods Recalls Thai Sweet Chili Sauce Due to Mislabeling

    Lancaster Fine Foods Inc. is recalling 1.5 oz. cups of Thai Sweet Chili Sauce because some cups were mislabeled as Spicy Mayonnaise Sauce.

    Product
    1.5 oz. cup with seal on label reading: Thai Sweet Chili Sauce; Ingredients: Thai Sweet Chili Sauce (Sugar, Water, Pickled Red Chili, Vinegar, Garlic, Salt, Xanthan Gum); Net Wt. 1.5 oz.; coded: BB 07/04/18, BB 07/05/18
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V211000·2018-04-03

    Toyota Recalls 2017-2018 Models for Brake Booster Vacuum Pump Defect

    Toyota is recalling specific 2017-2018 Camry, Highlander, Sienna, Tacoma, and Lexus RX350 vehicles because a manufacturing defect in the brake booster vacuum pump may cause a sudden loss of brake assist.

    Product
    TOYOTA — TOYOTA, LEXUS SIENNA, TACOMA, RX350, HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V208000·2018-03-29

    Mercedes-Benz Recalls 2018 Models for Driver Air Bag Inflator Defect

    Mercedes-Benz is recalling 2018 AMG GT, AMG GT C, GLC43 AMG, GLC300, and GLC350e vehicles because defective steel in the driver-side air bag inflator housing may cause rupture during deployment.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLC 350 E, GLC 300, AMG GLC43, AMG GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V203000·2018-03-29

    Alfa Romeo Stelvio Recall for Liftgate Wiring Water Leak

    FCA US LLC is recalling 2018 Alfa Romeo Stelvio vehicles because water leaks into liftgate wiring, causing corrosion that may allow the liftgate to open while driving.

    Product
    ALFA ROMEO — ALFA ROMEO STELVIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V206000·2018-03-29

    Spartan Gladiator Recall for Front Axle Spindle Failure Risk

    Spartan Motors is recalling 2004-2007 Gladiator emergency response vehicles because front axle spindles may crack and fail, potentially causing a wheel to separate.

    Product
    SPARTAN — SPARTAN GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V199000·2018-03-29

    Navistar Recalls 2018-2019 International LT Trucks for Fuel Leak Risk

    Navistar is recalling 2018-2019 International LT trucks because a fender splash panel may rub against the fuel line, causing a leak that could lead to fire or crash.

    Product
    INTERNATIONAL — INTERNATIONAL LT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E017000·2018-03-29

    Timoney Front Suspension Recall Due to Axle Spindle Fatigue Cracks

    Timoney Technology is recalling Mark 1 and Gen 2 Independent Front Suspensions because inconsistent machining may cause axle spindle failure and wheel separation.

    Product
    SUSPENSION:FRONT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide