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.

28726–28750 of 32252

  • SevereFDA (Devices)·Z-0844-2013·2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling 56 NeuroPath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0999-2013·2013-02-27

    Tumalo Farms Recalls Improperly Pasteurized Jewell Soft Brie-Style Cheese

    Tumalo Farms LLC is recalling 222 six-ounce pucks of Jewell soft brie-style cheese because it was improperly pasteurized. The product was distributed in Washington and Oregon.

    Product
    A soft brie-style cheese called Jewell. Ingredients: Certified organic cows' milk, Pasteurized farmstead goats' milk, cultures, rennet and salt. (information obtained from firm's web site)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0862-2013·2013-02-27

    Codman & Shurtleff Recalls Neuropath Guiding Catheters Due to Sterility Concerns

    Codman & Shurtleff is recalling Neuropath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility. The recall covers 10 units distributed worldwide.

    Product
    NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0829-2013·2013-02-27

    DePuy LPS Diaphyseal Sleeves Recalled for Potential Taper Fracture

    DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves because the taper connection may fracture under normal physiologic loads.

    Product
    LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0849-2013·2013-02-27

    Codman & Shurtleff Recalls NeuroPath Guiding Catheters Due to Sterility Concerns

    Codman & Shurtleff is recalling 266 units of NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0857-2013·2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V056000·2013-02-22

    Daimler Orion VII Transit Buses Recalled for Brake Chamber Leak

    Daimler Buses North America is recalling 2011-2012 Orion VII buses because leaking brake chambers may cause the parking brake to drag, potentially leading to overheated components and fire.

    Product
    ORION — ORION VII
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V058000·2013-02-22

    Porsche Recalls 2012-2013 911 Models for Exhaust Tail Pipe Fracture Risk

    Porsche is recalling 2012-2013 911 Carrera and Carrera 4 vehicles because the exhaust tail pipe may fracture and separate, posing a hazard to other vehicles.

    Product
    PORSCHE — PORSCHE 911 CARRERA 4, 911 CARRERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V076000·2013-02-22

    Fontaine Heavy-Haul Recalls 2013 Renegade Trailers Due to Structural Defect

    Fontaine Heavy-Haul is recalling 78 model year 2013 Renegade LX40 and LXT40 lowbed trailers because a connecting plate may crack and fail, increasing crash risk.

    Product
    FONTAINE — FONTAINE RENEGADE LXT40, RENEGADE LX40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0995-2013·2013-02-20

    HEB Deli Sweet and Sour Chicken Recalled for Salmonella Risk

    He Butt Grocery Company is recalling HEB Deli Sweet and Sour Chicken products in Texas due to potential Salmonella contamination.

    Product
    HEB Deli Sweet and Sour Chicken Entree UPC 0026967200000; HEB Deli HE Bowl Sweet and Sour Chicken UPC 0026967800000; HEB Deli Sweet and Sour Chicken UPC 0026705000000
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0749-2013·2013-02-20

    GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

    GE Healthcare is recalling 276 Giraffe and Panda Bag and Mask Resuscitation Systems because oxygen and air inlet fittings were reversed during assembly.

    Product
    Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Medical Device
    Distribution
    31 states
  • SevereFDA (Food)·F-0994-2013·2013-02-20

    HEB Deli Sesame Chicken Products Recalled for Salmonella Risk

    H-E-B is recalling four varieties of deli sesame chicken products sold in Texas due to potential salmonella contamination.

    Product
    HEB Deli Sesame Chicken Entree UPC 0026960600000; HEB Deli HE Bowl Sesame Chicken UPC 0026967700000; HEB Deli Sesame Chicken Retail Pack UPC 0026521900000; HEB Deli Sesame Chicken UPC 0026704500000
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0763-2013·2013-02-20

    St. Jude Medical Recalls TorqVue FX Delivery Systems Due to Fracture Risk

    St. Jude Medical is recalling 635 TorqVue FX Delivery Systems because the core wire could fracture during use.

    Product
    St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0984-2013·2013-02-20

    Altiza Recalls Malichita Brand Cucumbers Due to Salmonella Contamination Risk

    Altiza Inc. is recalling Malichita brand cucumbers because they may be contaminated with Salmonella. The affected product was distributed in California.

    Product
    Cucumbers, 44 lbs/box. Brand: Malichita (green, yellow, red and white background color on each cartons)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0993-2013·2013-02-20

    H-E-B Recalls Lemon Grass Chicken Deli Products Due to Salmonella Risk

    H-E-B is recalling specific Lemon Grass Chicken deli products in Texas due to potential Salmonella contamination.

    Product
    HEB Deli Lemon Grass Chicken Entree UPC 0026967100000; HEB Deli HE Bowl Lemon Grass Chicken UPC 0026967600000; HEB Deli Lemon Grass Chicken Retail Pack UPC 0026521800000; HEB Deli Lemon Grass Chicken UPC 0026705200000
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0974-2013·2013-02-20

    Suadel Empanadillas Recalled for Undeclared Wheat and Soy Allergens

    Suadel Food Products is recalling Empanadillas Sabor a Carne because wheat and soy are not declared on the label.

    Product
    "Estrella Food Products, Inc***Empanadillas Sabor a Carne(Meat flavorTurnovers)***5 units, 12 units and 24 units***Elaborado y Empacado por: Estrella Food Products, Inc., Bayamon, PR 00959-1906***".
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0795-2013·2013-02-20

    Lumenis Recalls VersaCut Tissue Morcellator for Labeling Corrections

    Lumenis Limited is recalling VersaCut Tissue Morcellator devices to correct labeling following three reported air embolism events caused by incorrect tubing hook-up.

    Product
    The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0986-2013·2013-02-20

    Pamela's Chocolate Chunk Cookie Mix Recalled for Potential Glass or Plastic Fragments

    Pamela's Products is recalling 1,709 cases of Chocolate Chunk Cookie Mix due to potential glass or plastic fragments.

    Product
    Pamela's Chocolate Chunk Cookie Mix; Gluten Free, Wheat Free, Non Dairy 13.9 oz. package. UPC 93709-30050 Pamela's Products, Ukiah, CA 95482
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0748-2013·2013-02-20

    GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

    GE Healthcare is recalling 276 Giraffe and Panda T-Piece Resuscitation Systems because oxygen and air inlet fittings were reversed during assembly.

    Product
    GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Medical Device
    Distribution
    31 states
  • SevereFDA (Drugs)·D-161-2013·2013-02-20

    Lee Pharmaceuticals Recalls 12-Hour Sinus Nasal Spray Due to Microbial Contamination

    Lee Pharmaceuticals is recalling 12-Hour Sinus Nasal Spray products due to microbial contamination identified during testing.

    Product
    12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Proudly Distributed By: Valu Merchandisers, Co., Kansas City, MO 64111, UPC 0 70038 61226 1; b) Nasal Spray Sinus, Distributed by Discount Drug…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0990-2013·2013-02-20

    Tropical Nut & Fruit Recalls Chia Seed Sticks for Undeclared Peanuts

    Tropical Nut & Fruit Co. is recalling 1,380 lbs of Chia ReCharged Stix Mix due to undeclared peanuts. The product was distributed in Florida and North Carolina.

    Product
    Labeled in part: "All Natural Chia ReCharged Stix Mix***Chia Seed Sticks***Net Wt. 5oz", UPC Code: 0 94184 01014 6
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0991-2013·2013-02-20

    Cheesy Broccoli Soup Recalled Due to Undeclared Shrimp

    Diversified Foods & Seasonings is recalling Cheesy Broccoli Soup because a consumer found shrimp in the product. The recall covers 189 cases distributed in Tennessee and Mississippi.

    Product
    CULINARY Creations (brand) CHEESY BROCCOLI SOUP, 3F3080, CONTAINS: 20/2 LB. CHUBS, NET WT. 40 LBS. 91816 KG), DIVERSIFIED FOODS AND SEASONINGS, INC, 1115 N. CAUSEWAY BLVD. STE.200, MANDEVILLE, LA 70471 1-800-835-3374, FOR INSTITUTIONAL USE ONLY, UPC 00732628330803
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·13V055000·2013-02-15

    Prevost Recalls H3-41 and H3-45 Coaches for Steering Defect

    Prevost is recalling 6,120 H3-41 and H3-45 coaches because a steering component may fracture, causing loss of vehicle control.

    Product
    PREVOST — PREVOST H3-41, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13725·2013-02-14

    John Deere Recalls Gator Utility Vehicles Due to Fire Hazard

    John Deere is recalling about 4,700 Gator RSX850i utility vehicles because oil filters may leak, posing a fire hazard. No injuries have been reported.

    Product
    Utility Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide