The Recall Desk

Archive

August 2018 recalls

863 recalls were announced in August 2018.

What the numbers show

Critical
26
Severe
214
High
393
Moderate
191
Low
39

Of the 863 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.

601–700 of 863

  • HighFDA (Food)·F-1822-2018·2018-08-08

    Subco Foods Recalls Chocolate Yogurt Pouches Due to Salmonella Risk

    Subco Foods Inc. is recalling 357 cases of Only 8 Chocolate Yogurt because the whey used in the product was potentially contaminated with Salmonella.

    Product
    Only 8 Chocolate Yogurt 2.7 pound pouch 6 pouches per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2587-2018·2018-08-08

    GE Healthcare Recalls CT Systems with Potential Electrical Wiring Defect

    GE Healthcare is recalling 42 CT and CT/PET systems installed with a specific electrical panel that may not be properly wired to the uninterruptible power supply.

    Product
    CT Goldseal BrightSpeed 16 PWR TIO 2 YR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1778-2018·2018-08-08

    Mondelez Recalls Ritz Bitz Cookies Due to Potential Salmonella in Ingredient

    Mondelez Global is recalling Ritz Bitz cookies because a whey powder ingredient may contain Salmonella. The recall covers products shipped to the U.S. and several international locations.

    Product
    20Z NAB CKIES CLASSIC MULTI PK 4 20 Oz, Carton, 5 Ritz Bitz 1 Oz Pouches per box 4 boxes per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1810-2018·2018-08-08

    Innova Flavors Recalls Natural Butter Flavor Due to Salmonella Risk

    Innova Flavors is voluntarily recalling specific lots of Natural Butter Flavor because a supplier's sweet whey powder ingredient is potentially contaminated with Salmonella.

    Product
    Natural Butter Flavor, 40 pounds, Powder in a blue poly-lined cardboard box, Ambient
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1863-2018·2018-08-08

    Griffith Labs Recalls Beef Flavored Gravy Mix Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling Beef Flavored Gravy Mix because it may contain Salmonella from a recalled whey ingredient.

    Product
    Beef Flavored Gravy Mix 12 oz unit, 8 units per carton Item 860143801 UPC 9624817621
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1887-2018·2018-08-08

    Griffith Labs Recalls Cheese and Garlic Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 55-pound bags of Cheese & Garlic Seasoning due to potential Salmonella contamination from a recalled whey ingredient.

    Product
    Cheese & Garlic Seasoning 55 pound bag Item 1000010004
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1867-2018·2018-08-08

    Griffith Labs Recalls Cold Dough Premix Due to Potential Salmonella

    Griffith Labs U.S.A. is recalling Cold Dough Premix because it may contain Salmonella from a recalled whey ingredient.

    Product
    Cold Dough Premix 2.303 pound bag, 18 units per carton Item 127042500
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1872-2018·2018-08-08

    Griffith Labs Recalls Cheddar Snack Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 23 drums of East Cheddar Snack Seasoning because it may contain Salmonella from a recalled whey ingredient.

    Product
    East Cheddar Snack Seasoning 200 pound drum Item 702118701
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1812-2018·2018-08-08

    Innova Flavours Recalls Natural Flavor Ham Type Powder Due to Salmonella Risk

    Innova Flavours is voluntarily recalling Natural Flavor Ham Type powder because a supplier's sweet whey powder ingredient is potentially contaminated with Salmonella.

    Product
    Natural Flavor Ham Type, 40 pounds, Powder in a blue poly-lined cardboard box, Ambient
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2561-2018·2018-08-08

    Galt Medical Recalls Sterile Access Kits Due to Bacterial Endotoxins

    Galt Medical Corporation is recalling specific sterile transcarotid and peripheral access kits because they may contain unsafe levels of bacterial endotoxins.

    Product
    1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1821-2018·2018-08-08

    Subco Foods Recalls Vanilla Yogurt Pouches Due to Salmonella Risk

    Subco Foods Inc. is recalling 1,010 cases of Only 8 Vanilla Yogurt because the whey used in the product was potentially contaminated with Salmonella.

    Product
    Only 8 Vanilla Yogurt 2.8 pound pouch 6 pouches per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2576-2018·2018-08-08

    Arrow International Recalls Percutaneous Sheath Introducer Kits Due to Latex Labeling Error

    Arrow International is recalling 60 units of Percutaneous Sheath Introducer Kits because the product contains dry natural rubber latex but is labeled as latex-free.

    Product
    Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1678-2018·2018-08-08

    Kauffman's Fruit Farm Sweet Apple Cider Recalled for High Patulin Levels

    Kauffman's Fruit Farm is recalling Sweet Apple Cider in multiple sizes due to high patulin levels. The product was distributed in New Jersey, Pennsylvania, and Virginia.

    Product
    Kauffman's Fruit Farm & Market Sweet Apple Cider; Keep Refrigerated; Kauffman's Fruit Farm, Bird-in-Hand, PA 17505; Enjoy thru 08/02/18. Packed in Net Wt 128 Fl. Oz.; 64 Fl. Oz.; 32 Fl. Oz.; 16 Fl. Oz. and 12 Fl. Oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1865-2018·2018-08-08

    Griffith Labs Recalls Brown Gravy Mix Due to Potential Salmonella

    Griffith Labs U.S.A. is recalling Brown Gravy Mix because it may contain Salmonella from a recalled whey ingredient.

    Product
    Brown Gravy Mix 12 oz unit, 8 units per carton Item 860144000 UPC 9624817641
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1864-2018·2018-08-08

    Griffith Labs Recalls Low Sodium Brown Gravy Mix for Salmonella Risk

    Griffith Labs U.S.A. is recalling Low Sodium Brown Gravy Mix due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Low Sodium Brown Gravy Mix 12 oz unit, 8 units per carton Item 860143100 UPC 9624817431
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2595-2018·2018-08-08

    Integra LifeSciences Recalls Mayfield Spine Table Adaptors Due to Fracture Risk

    Integra LifeSciences is recalling 95 Mayfield Spine Table Adaptors because the knob assembly may fracture during use, posing a risk to patients.

    Product
    MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1891-2018·2018-08-08

    Griffith Labs Garlic Cheese Crouton Seasoning Recalled for Salmonella Risk

    Griffith Labs U.S.A. is recalling Garlic Cheese Crouton Seasoning due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Garlic Cheese Crouton Seasoning 50 pound bag Item 859086200
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1788-2018·2018-08-08

    General Mills Recalls Cheerios Protein Oats and Honey Cereal

    General Mills is recalling Cheerios Protein Oats and Honey cereal due to potential Salmonella contamination. Consumers should check expiration dates and stop eating the product.

    Product
    Cheerios Protein Oats & Honey, Packaged in the following sizes: Net Wt. 19 oz. (583g) UPC 16000-44473. 12 boxes/case, Net Wt. 14.1 oz. (399g) UPC 16000-45137. 16 boxes/case. Dist. By General M ills Sales, Inc., Minneapolis, MN 55440 USA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1875-2018·2018-08-08

    Griffith Labs Recalls Chicken Fried Country Gravy Mix Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 50-pound bags of Chicken Fried Country Gravy Mix because a whey ingredient used in the product was recalled for potential Salmonella contamination.

    Product
    Chicken Fried Country Gravy Mix 50 pound bag Item 1000013694
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1897-2018·2018-08-08

    Griffith Labs Recalls Italian Crouton Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 50-pound bags of Italian Crouton Seasoning because it may contain Salmonella from a recalled whey ingredient.

    Product
    Italian Crouton Seasoning 50 pound bag Item 1000012969
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1809-2018·2018-08-08

    Innova Flavors Recalls Natural Flavor Turkey Type Powder Due to Salmonella Risk

    Innova Flavors is voluntarily recalling Natural Flavor Turkey Type powder because a supplier's sweet whey powder is potentially contaminated with Salmonella.

    Product
    Natural Flavor Turkey Type, 40 pounds, Powder in a blue poly-lined cardboard box, Ambient
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1808-2018·2018-08-08

    New Seasons Cauliflower Pilaf Meal Kit Recalled for Allergen Mislabeling

    New Seasons Market LLC is recalling Cauliflower Pilaf meal kits because the almond container was mislabeled as peanut. The recall covers 86 units distributed in Oregon and Washington.

    Product
    Cauliflower Pilaf with Fresh Turmeric and Fennel, New Seasons Kitchen Collective Meal Kits, Net wt. 2 lb 4 oz (1007 gr), UPC 840600109563. The ingredients statement of the finished product package is labeled in parts: ***INGREDIENTS: Cauliflower, Water, Fennel, Onion, Lemon
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1781-2018·2018-08-08

    Mondelez Recalls 3Z Rits Bits Cheese Go Pak for Salmonella Risk

    Mondelez Global is recalling 3Z Rits Bits Cheese Go Pak products due to a potential Salmonella risk in a whey powder ingredient.

    Product
    3Z RITS BITS CHEESE GO PAK 12 ( 8 & 18) 3 Oz Cups, 12 cups per tray
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2602-2018·2018-08-08

    Zimmer Dermatone AN Skin Graft Device Recalled for Loose Control Bar

    Zimmer Surgical Inc is recalling 140 units of the Zimmer Dermatone AN skin graft device due to a loose control bar that may compromise graft thickness control.

    Product
    Zimmer Dermatone AN, Model No. 88710100
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Food)·F-1878-2018·2018-08-08

    Griffith Labs Recalls Asiago Peppercorn Due to Potential Salmonella

    Griffith Labs U.S.A. is recalling 60 bags of Asiago Peppercorn due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Asiago Peppercorn 50 pound bag, Item 859081400
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1724-2018·2018-08-08

    Holmquist Hazelnut Orchards Recalls Butter Toffee Flavored Hazelnuts for Allergen Labeling

    Holmquist Hazelnut Orchards is recalling Butter Toffee Flavored Hazelnuts because the packaging fails to declare milk as an allergen, despite containing butter.

    Product
    Butter Toffee Flavored Hazelnuts, packaged in a clear plastic bag, net wt 6 oz. UPC 7 39059 30612 1. The label is read in parts: "***Butter Toffee Flavored Hazelnuts *** Ingredients: Dry Roasted Hazelnuts, Sugar, Butter, Sea Salt and Natural Vanilla Extract *** Contains Dairy.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1860-2018·2018-08-08

    Griffith Labs Recalls Milk and Egg Mix Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling specific lots of Milk and Egg Mix because a whey ingredient used in production was recalled for potential Salmonella contamination.

    Product
    Milk and Egg Mix 12 oz bag, 32 bags per carton Item 1000015014
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1873-2018·2018-08-08

    Griffith Labs Recalls East Cheddar Due to Potential Salmonella

    Griffith Labs U.S.A. is recalling 67 totes of East Cheddar cheese due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    East Cheddar SNKSE 1600 pound tote Item 702118702
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2018·2018-08-08

    Siemens SOMATOM Perspective 16 CT Scanner Recalled for Software Issue

    Siemens Medical Solutions USA is recalling SOMATOM Perspective 16 CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Perspective 16 (Model 10891666)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2473-2018·2018-08-08

    Siemens SOMATOM Emotion 16 CT Scanner Recalled for Radiation Risk

    Siemens Medical Solutions is recalling SOMATOM Emotion 16 CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Emotion 16 (10165977)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2571-2018·2018-08-08

    Cayenne Medical Recalls Quattro Link Drills Due to Breakage Trend

    Cayenne Medical Inc. is recalling 229 Quattro Link drills because a review of complaints identified a trend for the devices breaking.

    Product
    Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2562-2018·2018-08-08

    Galt Medical Elite HV Introducer Recalled for Bacterial Endotoxins

    Galt Medical Corporation is recalling Elite HV Introducers due to potential unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1811-2018·2018-08-08

    Innova Flavours Recalls Garlic Herb Flavor Due to Salmonella Risk

    Innova Flavours is voluntarily recalling Natural Roasted Garlic Herb Flavor because a supplier's sweet whey powder is potentially contaminated with Salmonella.

    Product
    Natural Roasted Garlic Herb Flavor, 40 pounds, Powder in a blue poly-lined cardboard box, Ambient
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1894-2018·2018-08-08

    Griffith Labs Herb Crouton Seasoning Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling 50-pound bags of Herb Crouton Seasoning due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Herb Crouton Seasoning 50 pound bag Item 702046300
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1866-2018·2018-08-08

    Griffith Labs Recalls Pork Flavored Gravy Mix Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling Pork Flavored Gravy Mix due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Pork Flavored Gravy Mix 12 oz unit, 8 units per carton Item 860143501 UPC 096248176614
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2018·2018-08-08

    Galt Medical Recalls Centesis Catheters Due to Bacterial Endotoxin Contamination

    Galt Medical Corporation is recalling specific lots of Drainer and Centeze Centesis Catheters because they may contain unsafe levels of bacterial endotoxins.

    Product
    1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1869-2018·2018-08-08

    Griffith Labs Recalls Reduced Whey Cold Dough Premix Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling Reduced Whey Cold Dough Premix because it may contain Salmonella from a recalled whey ingredient. The product was distributed nationwide and in Canada.

    Product
    Reduced Whey Cold Dough Premix 2.3 pound bag, 18 units per carton Item 127038500
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1881-2018·2018-08-08

    Griffith Labs Recalls Butter Garlic Crouton Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 50-pound bags of Butter Garlic Crouton Seasoning because it may contain Salmonella from a recalled whey ingredient.

    Product
    Butter Garlic Crouton Seasoning 50 pound bag, Item 859061100
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1893-2018·2018-08-08

    Griffith Labs Recalls Garlic Parmesan Due to Potential Salmonella

    Griffith Labs U.S.A. is recalling 50-pound bags of Garlic Parmesan because they may contain Salmonella from a recalled whey ingredient.

    Product
    Garlic Parmesan 50 pound bag Item 859075900
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1859-2018·2018-08-08

    Griffith Labs Dry Milk and Egg Mix Recalled for Salmonella Risk

    Griffith Labs U.S.A. is recalling Dry Milk and Egg Mix due to potential Salmonella contamination from a recalled whey ingredient.

    Product
    Dry Milk and Egg Mix 12 oz bag, 24 bags per carton Item 915004800
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1896-2018·2018-08-08

    Griffith Labs Italian Crouton Seasoning Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling 555 bags of Italian Crouton Seasoning due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Italian Crouton Seasoning 50 pound bag Item 1000017039
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1862-2018·2018-08-08

    Griffith Labs Recalls Brown Gravy Mix Due to Potential Salmonella

    Griffith Labs U.S.A. is recalling Brown Gravy Mix because it may contain Salmonella from a recalled whey ingredient.

    Product
    Brown Gravy Mix 16 oz unit, 24 units per carton Item 1000011214
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1775-2018·2018-08-08

    Mondelez Recalls Ritz Sandwiches Due to Potential Salmonella in Ingredient

    Mondelez Global is recalling Ritz Sandwiches with Cheese because a supplier's whey powder ingredient may contain Salmonella.

    Product
    10.8Z RITZ SANDWICH WITH CHEESE 14 (2 & 13) 10.8 Oz per tray, Plastic sleeve in tray 14 trays per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2593-2018·2018-08-08

    MAYFIELD Infinity XR2 Base Unit Recalled Due to Fracture Risk

    Integra LifeSciences is recalling 17 MAYFIELD Infinity XR2 Base Units because the knob assembly may fracture during use.

    Product
    MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18758·2018-08-08

    Polaris Recalls Gravely Utility Vehicles Due to Fire and Burn Hazards

    Polaris is recalling about 2,100 Gravely Atlas JSV 3000 and 6000 utility vehicles because a cracked exhaust header pipe poses fire and burn risks.

    Product
    Gravely Atlas JSV 3000 and 6000 utility vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1899-2018·2018-08-08

    Griffith Labs Recalls Romano Garlic Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 50-pound bags of Romano Garlic Seasoning due to potential Salmonella contamination from a recalled whey ingredient.

    Product
    Romano Garlic Seasoning 50 pound bag Item 1000015205
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1874-2018·2018-08-08

    Griffith Labs Recalls Sour Cream and Onion Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 200-pound drums of Sour Cream & Onion Snack Seasoning because a whey ingredient used in the product was previously recalled for potential Salmonella contamination.

    Product
    Sour Cream & Onion Snack Seasoning 200 pound drum Item 702083400
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1898-2018·2018-08-08

    Griffith Labs Onion Garlic Seasoning Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling 50-pound bags of Onion Garlic Seasoning due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Onion Garlic Seasoning 50 pound bag Item 1000025776
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1900-2018·2018-08-08

    Griffith Labs Recalls Seasoned Crouton Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 183 bags of Seasoned Crouton Seasoning N5 due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Seasoned Crouton Seasoning N5 50 pound bag Item 1000011143
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1895-2018·2018-08-08

    Griffith Labs Herb Crouton Seasoning Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling 40 bags of Herb Crouton Seasoning due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Herb Crouton Seasoning 50 pound bag Item 859021000
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2018·2018-08-08

    Baxter Recalls Power Cords for AMIA Automated PD Cycler

    Baxter Healthcare is recalling power cords for the AMIA Automated PD Cycler because the socket may detach when unplugged.

    Product
    power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1892-2018·2018-08-08

    Griffith Labs Recalls Garlic Onion Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 50-pound bags of Garlic Onion Seasoning because they may contain Salmonella from a recalled whey ingredient.

    Product
    Garlic Onion Seasoning 50 pound bag Item 859035900
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1888-2018·2018-08-08

    Griffith Labs Recalls Cheese and Garlic Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 50-pound bags of Cheese & Garlic Seasoning because it may contain Salmonella from a recalled whey ingredient.

    Product
    Cheese & Garlic Seasoning 50 pound bag Item 1000023698
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1877-2018·2018-08-08

    Griffith Labs Clam Chowder Base Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling Clam Chowder Base due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Clam Chowder Base 2 pound 6 oz bag, 12 bags per case Item 860117400
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1880-2018·2018-08-08

    Griffith Labs Recalls Butter Garlic Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 50-pound bags of Butter Garlic & Black Pepper Seasoning due to potential Salmonella contamination from a recalled whey ingredient.

    Product
    Butter Garlic & Black Pepper Seasoning 50 pound bag, Item 1000032662
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1774-2018·2018-08-08

    Mondelez Recalls Ritz Bits Cheese Big Bags Due to Salmonella Risk

    Mondelez Global is recalling Ritz Bits Cheese Big Bags because a supplier's whey powder ingredient may contain Salmonella.

    Product
    RITZ BITS CHEESE BIG BAG 3 Oz, Pouch Retail: 12 per case Foodservice: 36 per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2592-2018·2018-08-08

    Integra LifeSciences Recalls Mayfield Infinity XR2 Base Units

    Integra LifeSciences is recalling 409 Mayfield Infinity XR2 Base Units because the knob assembly in the swivel adapter may fracture or break during use.

    Product
    MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1889-2018·2018-08-08

    Griffith Labs Recalls Chili Lime and Nacho Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 25-pound bags of Chili Lime and Nacho Seasoning because they may contain Salmonella from a recalled whey ingredient.

    Product
    Chili Lime and Nacho Seasoning 25 pound bag Item 1000016381
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1858-2018·2018-08-08

    Griffith Labs Recalls Biscuit Mix Due to Potential Salmonella Risk

    Griffith Labs U.S.A. is recalling specific lots of Biscuit Mix because it may contain Salmonella from a recalled whey ingredient.

    Product
    Biscuit Mix 4.5 pound bag, 8 bags per carton Item 127042301
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2584-2018·2018-08-08

    GE Healthcare Recalls CT Systems With Potential Electrical Wiring Defect

    GE Healthcare is recalling 42 Revolution EVO 3.6 CT systems installed with a specific electrical panel that may not be properly wired to the UPS.

    Product
    Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1709-2018·2018-08-08

    Roctane Ultra Endurance Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling Roctane Ultra Endurance Energy Gels because testing confirmed the product may contain cyclamates.

    Product
    Roctane Ultra Endurance Energy Gels: Vanilla Orange Roc Gel: ROC GEL 1 Pkt, Item # 123059, UPC: 769493105028; ROC GEL 24 Pkt Box, Item # 123066, UPC:769493205025 .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2588-2018·2018-08-08

    bioMerieux Recalls VIDAS LH Test Kits Due to Calibration Issues

    bioMerieux, Inc. is recalling VIDAS LH test kits because internal tests confirmed a decrease in strip signal over time, leading to invalid calibration results.

    Product
    VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Lin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1688-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the product may contain cyclamates, an ingredient not listed on the label.

    Product
    GU Energy Gels: Gingerade, Gel; GUGEL 1 Pkt; item # 124297, UPC: 769493102409; GUGEL 24Pkt Box; item number 124296, UPC: 769493102393.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1696-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the presence of cyclamates, a substance not permitted in food.

    Product
    GU Energy Gels: Tastefully Nude, Gel; GUGEL 1 Pkt; item # 123835, UPC: 769493200976; GUGEL 24Pkt Box; item number 123836, UPC:769493200983.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1716-2018·2018-08-08

    Advanced Food Concepts Recalls GU Energy Stroopwafels Due to Cyclamates

    Advanced Food Concepts is recalling GU Energy Stroopwafels because testing confirmed the presence of cyclamates, an ingredient not listed on the label.

    Product
    GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie; Caramel Coffee, Waffle; WAFFLE 1 Pkt, Item # 124203, UPC: 769493101631; WAFFLE 16 Pkt Box, Item # 124199, UPC:769493101594;
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1700-2018·2018-08-08

    Roctane Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling Roctane Ultra Endurance Energy Gels because testing confirmed the presence of cyclamates.

    Product
    Roctane Ultra Endurance Energy Gels: Blueberry Pomegranate, Roc Gel: ROC GEL 1 Pkt, Item # 123058, UPC: 769493105011; ROC GEL 15 Serve Pkt, Item # 124103. UPC: 769493100917; ROC GEL 24 Pkt Box, Item # 123065, UPC: 769493205018
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1799-2018·2018-08-08

    Sugar Foods Recalls Zesty Italian Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling Zesty Italian Croutons because they were produced using recalled whey powder. The affected product was distributed in six states.

    Product
    Kitchen Fixins Zesty Italian Croutons: 5 oz. foil pouch Item # 31330 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1699-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the product may contain cyclamates, an unapproved food additive.

    Product
    GU Energy Gels: Vanilla Bean, Gel; GUGEL 1 Pkt; item # 123017, UPC: 769493100023; GUGEL 8Pkt Box, item # 123032, UPC: 769493900012; GUGEL 15 Serve Pkt, item # 124099, UPC: 769493100870; GUGEL 24Pkt Box; item number 123049, UPC:. 769493200020.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2569-2018·2018-08-08

    Stryker FlowGate2 Balloon Guide Catheter Recalled for Diameter Defect

    Stryker Neurovascular is recalling FlowGate2 Balloon Guide Catheters because the balloon diameter may exceed specifications, potentially causing resistance during use.

    Product
    FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1686-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the presence of cyclamates, an ingredient not declared on the label.

    Product
    GU Energy Gels: Espresso Lover Gel; GUGEL 1 Pkt; item # 123021, UPC:769493100078; GUGEL 24Pkt Box; item number 123050 , UPC769493200082 .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1694-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels in Salted Watermelon flavor because testing confirmed the presence of cyclamates.

    Product
    GU Energy Gels: Salted Watermelon, Gel; GUGEL 1 Pkt; item # 123030, UPC:769493100207; GUGEL 24Pkt Box; item number 123055, UPC:769493200211.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1033-2018·2018-08-08

    Renaissance Lakewood Recalls Fluconazole Injection Bags for Out-of-Specification Levels

    Renaissance Lakewood, LLC is recalling 12,088 bags of Fluconazole Injection because the lots are out of specification for elevated sodium chloride and fluconazole assay levels.

    Product
    Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2581-2018·2018-08-08

    GE Healthcare Recalls CT Systems with Potential Electrical Wiring Defect

    GE Healthcare is recalling 42 Discovery RT CT systems nationwide due to a potential wiring defect in the electrical panel that may affect the uninterruptible power supply.

    Product
    Discovery RT labeled as: a. MID BJG; b. HVY BJG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1018-2018·2018-08-08

    Vensun Pharmaceuticals Recalls Potassium Citrate Tablets Due to Breakage

    Vensun Pharmaceuticals is recalling 3,683 bottles of Potassium Citrate Extended-Release Tablets because they failed specifications due to tablet breakage.

    Product
    POTASSIUM CITRATE — POTASSIUM CITRATE (POTASSIUM CITRATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1723-2018·2018-08-08

    Advanced Food Concepts Recalls GU Energy Stroopwafels Due to Cyclamates

    Advanced Food Concepts is recalling GU Energy Stroopwafels because testing confirmed the presence of cyclamates, an unapproved food additive.

    Product
    GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie;, Wild Berries GF, Waffle; WAFFLE 1 Pkt, Item # 124206, UPC:769493101662 ; WAFFLE 16 Pkt Box, Item # 124202, UPC: 769493101624.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1687-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels in French Toast flavor because testing confirmed the presence of cyclamates.

    Product
    GU Energy Gels: French Toast, Gel; GUGEL 1 Pkt; item # 124523, UPC:769493103239; GUGEL 24Pkt Box; item number 124528 , UPC: 769493103246 .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1692-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels (Mint Chocolate) because testing confirmed the presence of cyclamates, a substance not permitted in food.

    Product
    GU Energy Gels: Mint Chocolate, Gel; GUGEL 1 Pkt; item # 124250, UPC:769493100108; GUGEL 24Pkt Box; item number 123943, UPC: 769493200136.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1711-2018·2018-08-08

    GU Energy Chews Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Chews because testing confirmed the presence of cyclamates, an ingredient not declared on the label.

    Product
    GU Energy Chews; Orange, Chews; CHEWS 1 Pkt, Item # 124182, UPC: 769493101457; CHEWS 18 Pkt Box, Item # 124178, UPC: 769493101419.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1713-2018·2018-08-08

    GU Energy Chews Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Chews because testing confirmed the presence of cyclamates, an ingredient not listed on the label.

    Product
    GU Energy Chews; Watermelon Chews; CHEWS 1 Pkt, Item # 124183, UPC: 769493101464 ; CHEWS 18 Pkt Box, Item # 124179, UPC:769493101426 .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1710-2018·2018-08-08

    GU Energy Chews Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Chews because testing confirmed the product may contain cyclamates, an ingredient not listed on the label.

    Product
    GU Energy Chews; Blueberry Pomegranate, Chews; CHEWS 1 Pkt, Item # 124181, UPC: 769493101440; CHEWS 18 Pkt Box, Item # 124177, UPC: 769493101402.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1693-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the presence of cyclamates, a substance not permitted in food.

    Product
    GU Energy Gels: Salted Caramel, Gel; GUGEL 1 Pkt; item # 123027, UPC:769493100184; GUGEL 8Pkt Box, Item # 123037, UPC: 769493900180; GUGEL 15 Serve Pkt, Item # 124098, UPC: 769493100863; GUGEL 24Pkt Box; item number 123041, UPC: 769493200198.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2575-2018·2018-08-08

    Randox Liquid Cardiac Control Level 3 Recalled for Precision Issues

    Randox Laboratories is recalling Liquid Cardiac Control - Level 3 due to unacceptable variation between vials that may delay Troponin T test results.

    Product
    Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-1801-2018·2018-08-08

    Sugar Foods Recalls Fresh Gourmet Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling Fresh Gourmet Cubed Seasoned Croutons because they were made with recalled whey powder.

    Product
    Fresh Gourmet Cubed Seasoned Croutons: 2.5 lb. foil pouch Item # 74461 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1677-2018·2018-08-08

    Byrd's Pink Lemonade Cookies Recalled for Missing Ingredient Labeling

    Byrd Cookie Company is recalling Pink Lemonade Cookies because Red 40 and Red 3 were not listed in the ingredients statement.

    Product
    PINK LEMONADE COOKIES Byrd's FAMOUS COOKIES; NET WT. 7 OZ .(198g) BOX; BYRD COOKIE COMPANY 6700 WATERS SAVANNAH, GA 31406 800-291-2973; UPC 7 48829 04946 5
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1690-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the presence of cyclamates, a substance not permitted in food.

    Product
    GU Energy Gels: Lemon Sublime, Gel; GUGEL 1 Pkt; item # 123023, UPC:769493100085; GUGEL 24Pkt Box; item number 123051, UPC: 769493200099.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1719-2018·2018-08-08

    Advanced Food Concepts Recalls Waffle Products Due to Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Stroopwafels and Hoka Campfire Smores waffles because testing confirmed the presence of cyclamates.

    Product
    GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie;, Hoka Campfire Smores, Waffle; WAFFLE 1 Pkt, Item # 124513, UPC: 769493103222; WAFFLE 16 Pkt Box, Item # 124512, UPC:769493103215;
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1685-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the presence of cyclamates, an ingredient not declared on the label.

    Product
    GU Energy Gels: Cucumber Mint, Gel; GUGEL 1 Pkt; item # 124123, UPC ;769493101020; GUGEL 24Pkt Box; item number 124125 , UPC 769493101044.
    Category
    Food
    Distribution
    0 states

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