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.

27626–27650 of 32222

  • SevereFDA (Devices)·Z-2097-2013·2013-09-04

    Megadyne Recalls E-Z Clean Laparoscopic Electrodes Due to Insulation Breach

    Megadyne Medical Products is recalling specific lots of E-Z Clean Disposable Laparoscopic Electrodes due to potential insulation breaches.

    Product
    E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is…
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Drugs)·D-923-2013·2013-09-04

    Novocol Recalls Subpotent Lidocaine and Epinephrine Dental Injection Lots

    Novocol is recalling two lots of Lidocaine 2% with Epinephrine 1:100,000 injection because the epinephrine component may be subpotent.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2077-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling 9 trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1856-2013·2013-09-04

    Whole Foods Recalls Sour Cherry Crostata for Unlabeled Egg Allergen

    Whole Foods Market is recalling Sour Cherry Crostata pies because egg wash is used in the product but is not listed on the ingredient list or allergen statement.

    Product
    Sour Cherry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g) Whole Foods Market Inc., Emeryville, CA 94608
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2130-2013·2013-09-04

    Stryker Triathlon Tibial Alignment Ankle Clamp Recalled for Cracks

    Stryker is recalling 10,537 Triathlon Tibial Alignment Ankle Clamps due to cracks or fractures. The instruments are used in total knee arthroplasty.

    Product
    Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1853-2013·2013-09-04

    See's Candies Recalls Dark Chocolate Blueberries Due to Missing Milk Labeling

    See's Candies is recalling Dark Chocolate Blueberries because milk was omitted from the ingredient list. The product was distributed in the US, Hong Kong, and Taiwan.

    Product
    See's Candies, Van Doren Dark Chocolate Blueberries; 8 oz. clear plastic packages. See's Candies Inc./See's Candy Shops Inc: South San Francisco, CA 94080/Los Angeles, CA 90016
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1851-2013·2013-09-04

    Whole Foods Recalls Morbier Cheese Due to Listeria Risk

    Whole Foods Market is recalling specific varieties of Trois Comtois Morbier cheese due to potential Listeria monocytogenes contamination linked to a French supplier recall.

    Product
    Trois Comtois Morbier Cheese labeled as follows: Morbier Raw Milk PLU 293358; Morbier AOC Le Trois PLU 293608; Morbier Raw Milk French Cheese PLU 293358; and Morbier Les Trois Comtois PLU 293608, Whole Foods Market
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-1857-2013·2013-09-04

    Whole Foods Recalls Blueberry Crostata for Unlabeled Egg Allergen

    Whole Foods Market is recalling Blueberry Crostata pies because egg wash is used in the product but is not listed on the ingredient or allergen statement.

    Product
    Blueberry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g) UPC: 0216733009993 Whole Foods Market Inc., Emeryville, CA 94608
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1850-2013·2013-09-04

    Les 3 Comtois Recalls Morbier Cheese Due to Listeria

    Les 3 Comtois is recalling 83 cases of Morbier cheese distributed in California, Illinois, and Wisconsin because FDA analysis detected Listeria monocytogenes.

    Product
    Morbier Les 3 Comtois, 11 lb. wheel; packaged in a cardboard case; one per case; refrigerated
    Category
    Food
    Distribution
    3 states
  • SevereCPSC·13275·2013-09-03

    Target Recalls White Floor Lamps Due to Fire and Shock Hazard

    Target is recalling approximately 25,000 white floor lamps sold in the U.S. and Canada due to a fire and shock hazard. Consumers should stop using the lamps and return them for a refund.

    Product
    White 2-Bulb Floor Lamp
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V392000·2013-08-30

    Spartan Motor Home Chassis Recall for ABS Valve Fracture Risk

    Spartan is recalling 2009-2014 motor home chassis because the ABS modulator valve may fracture, increasing stopping distance or causing the vehicle to pull.

    Product
    SPARTAN — SPARTAN K2, MM, K3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V391000·2013-08-30

    Indian Motorcycle Recalls 861 Models for Rear Rim Cracking Defect

    Indian Motorcycle is recalling 861 motorcycles from 2009-2013 because the rear rim may crack, causing a flat tire and potential loss of control.

    Product
    INDIAN — INDIAN DARK HORSE, CHIEF STANDARD, BOMBER, ROADMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V393000·2013-08-30

    Dutchmen Voltage Recalled for Generator Fuel Filter Clamp Defect

    Dutchmen is recalling 2014 Voltage recreational vehicles because the generator fuel filter clamp may be installed incorrectly. This defect could cause a fuel leak, increasing the risk of fire, injury, or property damage.

    Product
    DUTCHMEN — DUTCHMEN VOLTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V385000·2013-08-29

    Ford Recalls 2005-2011 Vehicles for Steering Column Corrosion Risk

    Ford is recalling 2005-2011 Crown Victoria, Grand Marquis, and Town Car vehicles in specific states because severe corrosion can cause steering loss.

    Product
    MERCURY — MERCURY, FORD, LINCOLN GRAND MARQUIS, CROWN VICTORIA, TOWN CAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1824-2013·2013-08-28

    NuGo Free Dark Chocolate Trail Mix Bar Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling specific lots of Free Dark Chocolate Trail Mix Bars because they may contain undeclared milk.

    Product
    NuGo Free Dark Chocolate Trail Mix Bar, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1826-2013·2013-08-28

    NuGo Free Carrot Cake Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling NuGo Free Carrot Cake bars because they may contain undeclared milk, posing a risk to individuals with milk allergies.

    Product
    NuGo Free Carrot Cake, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1827-2013·2013-08-28

    NuGo Dark Chocolate Chocolate Chip Bars Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling Dark Chocolate Chocolate Chip bars because they may contain undeclared milk, a major allergen.

    Product
    NuGo Dark Chocolate Chocolate Chip 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2028-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee implant components because surgeons are using them in unapproved combinations.

    Product
    00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; 00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 12, Rx, Sterile; 00595204114 Articular Surface XLPE CR ART SURF 5-6/STRGRN 14, Rx, Sterile; 00595204117 Articular Surface XLPE CR ART…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-915-2013·2013-08-28

    Fresenius Kabi Recalls Irinotecan Hydrochloride Injection Due to Crystallization

    Fresenius Kabi USA LLC is recalling 23,672 vials of Irinotecan Hydrochloride Injection because the active ingredient is precipitating in the solution.

    Product
    IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V386000·2013-08-28

    2013 Can-Am Spyder RT and ST Recalled for Brake Fire Risk

    NHTSA is recalling 2013 Can-Am Spyder RT and ST motorcycles because a brake component may melt, causing fluid leaks that increase fire risk.

    Product
    CAN-AM — CAN-AM SPYDER ST, SPYDER RT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1976-2013·2013-08-28

    Stryker Oasys Midline Occiput Plate Recalled for Post-Operative Pin Fracture

    Stryker Spine is recalling Oasys Midline Occiput Plates because customer reports indicate post-operative fracture of the pin connecting the tulip head to the plate body.

    Product
    Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1832-2013·2013-08-28

    NuGo Slim Crunchy Peanut Butter Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling NuGo Slim Crunchy Peanut Butter bars because they may contain undeclared milk, a major food allergen.

    Product
    NuGo Slim Crunchy Peanut Butter, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-912-2013·2013-08-28

    Wise Woman Herbals Eyebright Eye Rinse Recalled for Sterility Concerns

    Wise Woman Herbals is recalling Eyebright Concentrate Topical Eye Rinse because it was not manufactured under sterile conditions required for ophthalmic products.

    Product
    Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2039-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; 00597502014 Provisional AC ART SURF PROV 12/PUR 14, Rx, Sterile; 00597502017 Provisional AC ART SURF PROV 12/PUR 17, Rx, Sterile…
    Category
    Medical Device
    Distribution
    Distributed nationwide