The Recall Desk

Archive

June 2017 recalls

758 recalls were announced in June 2017.

What the numbers show

Critical
27
Severe
142
High
261
Moderate
293
Low
35

Of the 758 recalls this month scored against our rubric, 4% are Critical, 19% are Severe.

501–600 of 758

  • HighFDA (Food)·F-2275-2017·2017-06-14

    ISF USA Recalls Raw Breaded Fish Portions for Undeclared Milk

    ISF "USA", LLC is recalling A&W Raw Breaded Fish Portions due to undeclared milk. The recall affects 374 cases distributed within the United States.

    Product
    A&W, GIN 0040995 Raw Breaded Fish Portions 3.5 oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2337-2017·2017-06-14

    Lamb Weston Recalls Red Robin Crispy Onion Rings for Undeclared Milk

    Lamb Weston is recalling Red Robin Crispy Onion Rings because the frozen product contains undeclared milk, a major food allergen.

    Product
    Red Robin Burgers and Brews Crispy Onion Rings, frozen, Net wt. 14 ounce. Retail package UPC 0 43301 61119 3.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-2331-2017·2017-06-14

    Krisppee Clam Fry Mix Recalled for Undeclared Milk Allergen

    Krisppee Products Co. is recalling Clam Fry Mix in 5, 25, and 50 lb sizes because the product contains undeclared milk.

    Product
    KRISPPE CLAM-FRY-MIX NET WEIGHT 5 lbs., 25 lbs., 50 lbs.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2226-2017·2017-06-14

    Magellan LeadCare Blood Test Kits Underestimate Lead Concentrations

    Magellan Diagnostics is recalling LeadCare Ultra and Plus test kits because they may underestimate lead levels in venous blood samples.

    Product
    Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V379000·2017-06-14

    BMW Recalls 2013-2015 7 Series Vehicles for Incorrect Taillights

    BMW is recalling certain 2013-2015 7 Series and ActiveHybrid 7 vehicles because incorrect left rear taillight assemblies may reduce visibility to other drivers.

    Product
    BMW — BMW 750I, ACTIVE HYBRID 7, 740LXI, 740I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2327-2017·2017-06-14

    Choice Northwest Recalls Paradise Deli Hazelnut Cake for Undeclared Soy

    Choice Northwest is recalling Paradise Deli brand Hazelnut Cake because the product contains undeclared soy lecithin, a major food allergen.

    Product
    Hazelnut Cake, Paradise Deli brand, net wt. 15 oz., UPC 0 31619 10201 4. The label is read in parts: "***Contains: Oregon grown hazelnuts, cane sugar, organic unbleached wheat flour, fresh eggs, sea salt, pure vanilla***PARADISE DELI - PO Box 22411, Eugene, OR 97402 *** 925 37
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2301-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima Cinnamon French Toast for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Cinnamon French Toast due to potential Listeria monocytogenes contamination. The recall covers 22,172 units distributed nationwide.

    Product
    AUNT JEMIMA(R) CINNAMON FRENCH TOAST, 6 COUNT, NET WT 12.5oz, UPC 019600058908
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2341-2017·2017-06-14

    Alaska Pasta Company Recalls Gemelli for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated Gemelli pasta because it contains undeclared soy lecithin from cooking spray. The product was distributed only in Alaska.

    Product
    Gemelli. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2240-2017·2017-06-14

    ConvaTec Recalls Pediatric Oxygen Masks Due to Potential Valve Defect

    ConvaTec is recalling specific lots of pediatric oxygen masks because the check valve may not function correctly, potentially affecting oxygen delivery.

    Product
    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2274-2017·2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk

    Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2305-2017·2017-06-14

    Aunt Jemima Blueberry Waffles Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima 14 Blueberry Waffles due to potential Listeria monocytogenes contamination. The recall covers 153,513 units distributed nationwide.

    Product
    AUNT JEMIMA(R) 14 BLUEBERRY WAFFLES, NET WT 17.18oz UPC 019600062202
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2350-2017·2017-06-14

    Alaska Pasta Company Recalls Mushroom Ravioli for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated Mushroom Ravioli because it contains undeclared soy lecithin from cooking spray. The product was distributed only in Alaska.

    Product
    Ravioli Mushroom. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some c
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2255-2017·2017-06-14

    Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk

    Arrow International is recalling specific Central Venous Access Kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.

    Product
    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2351-2017·2017-06-14

    Alaska Pasta Company Recalls Ravioli Orso for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling Ravioli Orso because it contains undeclared soy lecithin from canola oil cooking spray. The product was distributed in Alaska.

    Product
    Ravioli Orso. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some conta
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2296-2017·2017-06-14

    Aunt Jemima Oatmeal Pancakes Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Oatmeal Pancakes due to a potential for Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) 12 OATMEAL PANCAKES, NET WT 14.8oz UPC 019600064909
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2280-2017·2017-06-14

    Arrow International Recalls Pressure Injectable PICC Kits Due to Needlestick Risk

    Arrow International is recalling Pressure Injectable PICC Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2017·2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk

    Arrow International is recalling 43,394 central venous catheter kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limite
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2017·2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk

    Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.

    Product
    ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2328-2017·2017-06-14

    Parade Deli Cake Recalled for Undeclared Soy Lecithin

    Choice Northwest is recalling Paradise Deli brand Love Your Heart Cake because it contains undeclared soy lecithin. The product was distributed in Oregon.

    Product
    Love Your Heart Cake, Paradise Deli brand, Net Wt. 14 oz., UPC 0 31619 40402 6. The label is read in parts: "***Contains: Fresh apples, fresh carrots, organic unbleached wheat flour, organic cane sugar, Oregon grown hazelnuts, raisins, cinnamon, baking soad, and baking powder*
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2352-2017·2017-06-14

    Alaska Pasta Company Recalls Ravioli Spinach Due to Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated Ravioli Spinach because it contains undeclared soy lecithin from cooking spray. The product was distributed in Alaska.

    Product
    Ravioli Spinach. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some con
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2339-2017·2017-06-14

    Alaska Pasta Company Recalls Refrigerated Fettuccine for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling 447.2 lbs of refrigerated fettuccine because it contains undeclared soy lecithin from cooking spray.

    Product
    Fettuccine. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some contain
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2223-2017·2017-06-14

    Roche Cobas Connection Module Recalled for Vibration and Contamination Risk

    Roche Diagnostics is recalling three Cobas connection modules in Washington due to a gap that may cause rack vibration, posing operator injury and sample cross-contamination risks.

    Product
    Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2236-2017·2017-06-14

    ConvaTec Recalls Rebreather Oxygen Masks Due to Defect

    ConvaTec is voluntarily recalling specific lots of Rebreather Oxygen Masks. The recall was initiated by the firm and is classified as Class II by the FDA.

    Product
    Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2243-2017·2017-06-14

    ConvaTec Recalls Pediatric Non-Rebreather Oxygen Masks Due to Defects

    ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen masks with tubing. The recall was initiated by the firm and is currently terminated.

    Product
    Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-2326-2017·2017-06-14

    Trophy Nut Co. Recalls Honey Bourbon Pecans for Undeclared Allergens

    Trophy Nut Co. is recalling 20 lb. cases of Honey Bourbon Pecans because the product contains undeclared allergens. The product was distributed to one manufacturer in Michigan.

    Product
    Honey Bourbon Pecans Net Wt. 20 lb. (9.088g) Mfg. By: Trophy Nut Co. Tipp City, OH 45371
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2294-2017·2017-06-14

    Arrow International Recalls Femoral Arterial Line Catheterization Kits

    Arrow International is recalling specific femoral arterial line catheterization kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2315-2017·2017-06-14

    Aunt Jemima Whole Grain Mini Pancakes Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Whole Grain Mini Pancakes due to a potential for Listeria monocytogenes contamination.

    Product
    Aunt Jemima(R) Whole Grain Mini Pancakes, 12-40 COUNT, NET WT 12 LBS, UPC 001960043558
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2017·2017-06-14

    ConvaTec Recalls Infant High Concentration Non-Rebreather Oxygen Masks

    ConvaTec is recalling specific lots of infant high concentration non-rebreather oxygen masks due to a Class II safety concern.

    Product
    Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-2349-2017·2017-06-14

    Alaska Pasta Company Recalls Ravioli Lobster Due to Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated Ravioli Lobster because it contains undeclared soy lecithin from cooking spray. The product was distributed only in Alaska.

    Product
    Ravioli Lobster. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some co
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2300-2017·2017-06-14

    Aunt Jemima Homestyle French Toast Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Homestyle French Toast due to potential Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) HOMESTYLE FRENCH TOAST, 6 COUNT, NET WT 12.5oz, UPC 019600057703
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2345-2017·2017-06-14

    Alaska Pasta Company Recalls Refrigerated Pappardelli for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated pappardelli pasta because it contains undeclared soy lecithin from cooking spray. The product was distributed in Alaska.

    Product
    Papperdelli ¿ inch. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2346-2017·2017-06-14

    Alaska Pasta Company Recalls Penne for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated penne pasta distributed in Alaska because it contains undeclared soy lecithin from cooking spray.

    Product
    Penne. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers ha
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2292-2017·2017-06-14

    Aunt Jemima Blueberry Mini Pancakes Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Lil' Griddles Blueberry Mini Pancakes due to a potential for Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) LIL' GRIDDLES(TM) BLUEBERRY MINI PANCAKES, 40 COUNT, NET WT 14.5oz UPC 019600054603
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2354-2017·2017-06-14

    Alaska Pasta Company Recalls Refrigerated Shells for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling 52.50 lbs of refrigerated shells due to undeclared soy lecithin from cooking spray. The product was distributed in Alaska.

    Product
    Shells. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers h
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2308-2017·2017-06-14

    Arrow International Recalls Hemodialysis Catheterization Kits

    Arrow International Inc. is recalling ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kits due to a Class II recall.

    Product
    ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2348-2017·2017-06-14

    Alaska Pasta Company Recalls Frozen Ravioli Cheese Due to Undeclared Soy Lecithin

    Alaska Pasta Company is recalling frozen Ravioli Cheese because it contains undeclared soy lecithin from canola oil cooking spray. The product was distributed in Alaska.

    Product
    Ravioli Cheese. Product is frozen. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers have
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2238-2017·2017-06-14

    ConvaTec Recalls Non-Rebreather Oxygen Masks Due to Quality Concerns

    ConvaTec is voluntarily recalling specific lots of adult non-rebreather oxygen masks. The recall was initiated due to quality concerns, with no specific injuries reported in the source text.

    Product
    Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2233-2017·2017-06-14

    ConvaTec Recalls Non-Rebreather Oxygen Masks Due to Quality Concerns

    ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreather Oxygen Masks. The recall was initiated due to quality concerns, though no specific defect is described in the source.

    Product
    Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2318-2017·2017-06-14

    Zimmer Biomet Recalls Vitality Spinal Fixation System Drivers

    Zimmer Biomet is recalling Vitality T27 Final Drivers and Torque Limiting Handles because they may create torsional springs that damage the device or cause torque values to go out of specification.

    Product
    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2319-2017·2017-06-14

    California Sun Dry Sun-Dried Tomato Pesto Recalled for Undeclared Allergens

    California Sun Dry Foods is recalling Sun-Dried Tomato Pesto because the label failed to declare almonds and milk.

    Product
    California Sun Dry Sun Dried Tomato Pesto; NET WT. 8.5 oz. (241g) glass jar; Ingredients (incorrect) Garlic, Canola oil, sundried tomatoes (preserved with sulfating agents) water, sola oil, spices, onion, salt, citric acid,, soy lecithin. Partially processed with Genetic En
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-2316-2017·2017-06-14

    Hilltop Hearth Waffles Recalled for Potential Listeria Contamination

    Pinnacle Foods is recalling Hilltop Hearth Waffles nationwide due to the potential for Listeria monocytogenes contamination.

    Product
    Hilltop HEARTH WAFFLES, 18 BOLSAS CON 8 PIEZAS, PESO NETO 11LB 6.4 oz, UPC075810843855
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2340-2017·2017-06-14

    Alaska Pasta Company Recalls Gluten-Free Fettuccine for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated gluten-free fettuccine because it contains undeclared soy lecithin from cooking spray.

    Product
    Fettuccine Gluten Free. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). S
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2245-2017·2017-06-14

    ConvaTec Recalls Pediatric High Concentration Non-Rebreather Oxygen Tubing

    ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen tubing due to a Class II defect. The recall covers units distributed across the US and multiple international countries.

    Product
    Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2228-2017·2017-06-14

    ConvaTec Recalls Elongated Oxygen Masks Due to Tubing Detachment Risk

    ConvaTec is recalling elongated oxygen masks because tubing may detach from the connector, potentially disrupting oxygen supply to users.

    Product
    Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-2302-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima French Toast for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima French Toast made with Whole Grain due to potential Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) FRENCH TOAST MADE WITH WHOLE GRAIN, 6 COUNT, NET WT 12.5oz, UPC 019600059684; Aunt Jemima(R) French toast made with Whole Grain, 72 COUNT, NET WT 11.25 LBS, UPC 001960043583
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2017·2017-06-14

    ConvaTec Recalls Rebreathing Masks with Reservoir Bags and Tubing

    ConvaTec, Inc. is voluntarily recalling Rebreathing Masks, Reservoir bags, with Tubing (Product Code 104MM) due to a Class II safety concern.

    Product
    Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2306-2017·2017-06-14

    Arrow International Recalls Two-Lumen Hemodialysis Catheterization Kits

    Arrow International Inc is recalling specific lots of two-lumen hemodialysis catheterization kits due to a Class II medical device recall.

    Product
    Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2307-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima Mini Pancakes for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Mini Pancakes due to a potential for Listeria monocytogenes contamination. The recall covers 8,344 units distributed nationwide.

    Product
    AUNT JEMIMA(R) MiNi pancakes, MAPLE BLAST, NET WT 3.2 OZ, UPC 001960043563
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2306-2017·2017-06-14

    Aunt Jemima Low Fat Waffles Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima 14 Low Fat Waffles nationwide due to potential Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) 14 LOW FAT WAFFLES, NET WT 17.18oz UPC 019600062301
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2017·2017-06-14

    Arrow QuickFlash Radial Artery Catheterization Kit Recalled for Needlestick Risk

    Arrow International is recalling QuickFlash Radial Artery Catheterization Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2304-2017·2017-06-14

    Aunt Jemima Waffles Recalled for Potential Listeria Contamination

    Pinnacle Foods is recalling Aunt Jemima Buttermilk Waffles due to potential Listeria monocytogenes contamination. The recall covers 403,583 units distributed nationwide.

    Product
    AUNT JEMIMA(R) 14 BUTTERMILK WAFFLES, NET WT 17.18oz UPC 019600062103
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2303-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima Waffles Due to Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Homestyle Waffles nationwide due to a potential for Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) 14 HOMESTYLE WAFFLES, NET WT 17.18oz UPC 019600062004
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2317-2017·2017-06-14

    Aunt Jemima Cinnamon Swirl French Toast Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Cinnamon Swirl Thick French Toast nationwide due to potential Listeria monocytogenes contamination.

    Product
    Aunt Jemima(R) Cinnamon Swirl Thick French Toast, 144 COUNT, NET WT 10.7 LBS, UPC 001960043584
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2344-2017·2017-06-14

    Alaska Pasta Company Recalls Refrigerated Linguine Due to Undeclared Soy Lecithin

    Alaska Pasta Company is recalling 78.50 lbs of refrigerated linguine distributed in Alaska because the product contains undeclared soy lecithin.

    Product
    Linguine. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some containers
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2312-2017·2017-06-14

    Aunt Jemima Thick French Toast Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Thick French Toast nationwide due to a potential for Listeria monocytogenes contamination.

    Product
    Aunt Jemima(R) Thick French toast, 72 COUNT, NET WT 10.7 LBS, UPC 001960043560
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2347-2017·2017-06-14

    Alaska Pasta Company Recalls Ravioli Butternut for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated Ravioli Butternut because it contains undeclared soy lecithin. The product was distributed only in Alaska.

    Product
    Ravioli Butternut. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some c
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2298-2017·2017-06-14

    Aunt Jemima Buttermilk Pancakes Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Buttermilk Pancakes due to potential Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) 12 BUTTERMILK PANCAKES, NET WT 14.8oz UPC 019600068204
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2355-2017·2017-06-14

    Alaska Pasta Company Recalls Spaghettoni Due to Undeclared Soy Lecithin

    Alaska Pasta Company is recalling 69.70 lbs of refrigerated Spaghettoni because it contains undeclared soy lecithin from cooking spray.

    Product
    Spaghettoni. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some contain
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2299-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima Homestyle Pancakes for Listeria Risk

    Pinnacle Foods is recalling specific Aunt Jemima Homestyle Pancakes due to potential Listeria monocytogenes contamination. Consumers should check their pantry for the affected UPC codes.

    Product
    Homestyle pancakes packaged as follows: a) AUNT JEMIMA(R) 12 HOMESTYLE PANCAKES, NET WT 14.8oz UPC 019600069102 b) AUNT JEMIMA(R) HOMESTYLE PANCAKES, 60 COUNT, NET WT 4.63 LBS, UPC 019600435907 c) AUNT JEMIMA(R) HOMESTYLE PANCAKES,60 COUNT (MEXICO), NET WT 4.29 LBS, UPC 01
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2309-2017·2017-06-14

    Aunt Jemima Mini Cinnamon Roll Pancakes Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Mini Cinnamon Roll Pancakes due to a potential for Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) MiNi pancakes, CINNAMON ROLL, NET WT 3.2 OZ, UPC 001960043568
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2293-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima Mini Pancakes Due to Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Lil' Griddles Mini pancakes nationwide due to a potential for Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) LIL' GRiDDLES(TM) MINI pancakes, 40 COUNT, NET WT 14.5oz UPC 019600054801
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2353-2017·2017-06-14

    Alaska Pasta Company Recalls Refrigerated Rigatoni for Undeclared Soy Lecithin

    Alaska Pasta Company is recalling 67.50 lbs of refrigerated rigatoni because it contains undeclared soy lecithin from cooking spray. The product was distributed only in Alaska.

    Product
    Riggatoni. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some container
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2247-2017·2017-06-14

    Medtronic Recalls KYPHON Directional Bone Filler Devices Due to Alignment Defect

    Medtronic is recalling KYPHON Directional Bone Filler Devices because the directional arrow may not align with the opening, potentially causing cement to be placed in an unintended direction.

    Product
    KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2235-2017·2017-06-14

    ConvaTec Recalls Elongated Oxygen Masks Due to Class II Safety Concerns

    ConvaTec is voluntarily recalling specific lots of elongated oxygen masks. The FDA classified this as a Class II recall, indicating a reasonable probability of temporary adverse health consequences.

    Product
    Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2227-2017·2017-06-14

    Zimmer CAS Recalls Sesamoid Plasty Workstations Due to Structural Instability

    Zimmer CAS is voluntarily recalling 10 Sesamoid Plasty workstations because the top of the unit may fall over during disassembly.

    Product
    Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2262-2017·2017-06-14

    Arrow PICC Kit Recall Due to Needlestick Injury Risk

    Arrow International is recalling specific PICC kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intraveno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2017·2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Injury Risk

    Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse needles have a safety cover disengagement defect that poses a needlestick injury risk.

    Product
    Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2250-2017·2017-06-14

    Circadiance Recalls SmartMonitor 2 PS/PSL Apnea Monitors for Nurse Call Defect

    Circadiance LLC is recalling 1,242 SmartMonitor 2 PS/PSL apnea monitors because the nurse call feature may operate intermittently, potentially preventing alarm transmission.

    Product
    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2249-2017·2017-06-14

    Alphatec Recalls Arsenal Spinal Fixation System Set Screws

    Alphatec Spine is recalling Arsenal Spinal Fixation System Set Screws due to a trend of postoperative disengagement from the screw body.

    Product
    Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Ars
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2294-2017·2017-06-14

    Aunt Jemima Buttermilk 12 Low Fat Pancakes Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Buttermilk 12 Low Fat Pancakes due to potential Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) BUTTERMILK 12 LOW FAT PANCAKES, NET WT14.5oz UPC 019600061007
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2314-2017·2017-06-14

    Aunt Jemima Cinnamon Swirl French Toast Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Cinnamon Swirl French Toast due to potential Listeria monocytogenes contamination.

    Product
    Aunt Jemima(R) Cinnamon Swirl French Toast, 144 COUNT, NET WT 13.5 LBS, UPC001960005880
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2313-2017·2017-06-14

    Pinnacle Foods Recalls Waffles for Potential Listeria Contamination

    Pinnacle Foods is recalling specific Aunt Jemima, Mrs. Butterworth's, and Hilltop Hearth waffle products due to potential Listeria monocytogenes contamination.

    Product
    Waffles packaged as follows: a) Aunt Jemima(R) Waffles, 144 COUNT, NET WT 7.88 LBS, UPC 001960043575 b) Aunt Jemima(R) Jumbo Square Waffles, 144 COUNT, NET WT 11.4 LBS, UPC 001960043573 c) Aunt Jemima(R) Waffles, 144 COUNT, NET WT 7.88 LBS, UPC 001960043575 d) Mrs. Butter-wo
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2017·2017-06-14

    ConvaTec Recalls Adult Non-Rebreather Masks Due to Defect

    ConvaTec, Inc. is voluntarily recalling adult non-rebreather masks with 'No-Crush' tubing. The recall was initiated in May 2017 and is now terminated.

    Product
    Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-2318-2017·2017-06-14

    Pinnacle Foods Recalls Mrs. Butter-worth's Original Pancakes for Listeria Risk

    Pinnacle Foods is recalling Mrs. Butter-worth's Original Pancakes due to potential Listeria monocytogenes contamination. The recall covers 243,669 units distributed nationwide.

    Product
    Mrs. Butter-worth's(R) ORIGINAL PANCAKES, 144 COUNT, NET WT 10.6 LBS, UPC 001960046004
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2343-2017·2017-06-14

    Alaska Pasta Company Recalls Spinach Lasagne Sheets for Undeclared Soy

    Alaska Pasta Company is recalling refrigerated spinach lasagne sheets because they contain undeclared soy lecithin from cooking spray.

    Product
    Lasagne Sheets Spinach. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). S
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2334-2017·2017-06-14

    Whole Foods Oatmeal Chocolate Chip Cookies Recalled for Undeclared Walnuts

    Whole Foods Market is recalling Oatmeal Chocolate Chip Cookies due to undeclared walnuts, a major food allergen.

    Product
    Oatmeal Chocolate Chip Cookies, 18pk, NET WT. 0 lb 10 oz (283 g), Dist. by Whole Foods Market, 1105 N. Lamar, Austin, TX 78703 USPC 0247181 004992
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2338-2017·2017-06-14

    Fourth Street Barbeque Recalls Chicken and Waffle Sandwiches for Listeria Risk

    Fourth Street Barbeque is recalling Pick 5 Chicken & Waffle Sandwiches due to potential Listeria monocytogenes contamination. The product was distributed nationwide by Save-A-Lot.

    Product
    Pick 5 Chicken & Waffle Sandwich; Mix & Match, Keep Frozen; Net Wt. 14.4 oz.; Distributed by: Save-A-Lot Food Stores, Ltd., Earth City, MO 63045; UPC: 051933353664
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2295-2017·2017-06-14

    Aunt Jemima Blueberry Pancakes Recalled for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima 12 Blueberry Pancakes nationwide due to potential Listeria monocytogenes contamination.

    Product
    AUNT JEMIMA(R) 12 BLUEBERRY PANCAKES, NET WT 14.8oz UPC 019600064701
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2342-2017·2017-06-14

    Alaska Pasta Company Recalls Lasagne Sheets Due to Undeclared Soy Lecithin

    Alaska Pasta Company is recalling refrigerated lasagne sheets because they contain undeclared soy lecithin from cooking spray. The product was distributed only in Alaska.

    Product
    Lasagne Sheets. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some cont
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2297-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima Pancakes for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima 12 Pancakes Made with Whole Grain due to potential Listeria monocytogenes contamination. The recall covers 6,955 units distributed nationwide.

    Product
    AUNT JEMIMA(R) 12 PANCAKES MADE WITH WHOLE GRAIN, NET WT 14.5oz UPC 019600066408
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2310-2017·2017-06-14

    Pinnacle Foods Recalls Hilltop Hearth French Toast for Listeria Risk

    Pinnacle Foods is recalling Hilltop Hearth and Mrs. Butter-worth's French Toast nationwide due to a potential for Listeria monocytogenes contamination.

    Product
    French toast packaged as follows: a) Hilltop HEARTH, FRENCH TOAST, 18 8 COUNT BAGS, NET WT 10 LB 11.2 OZ, UPC 075810861816 b) Hilltop HEARTH, FRENCH TOAST, 12 6 COUNT BAGS, NET WT 10 LB 11.2 OZ, UPC 075810843855 c) Hilltop HEARTH FRENCH TOAST, 12 6 COUNT BAGS, NET WT. 10 LB 11
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2311-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima French Toast for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Original Thin French Toast nationwide due to a potential for Listeria monocytogenes contamination.

    Product
    Aunt Jemima(R) Original Thin French toast, 144 COUNT, NET WT 13.5 LBS, UPC 001960005870
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2017·2017-06-14

    Arrow Central Venous Catheter Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling 43,394 units of ARROWg+ard Blue PLUS Two-Lumen Central Venous Catheterization Kits due to safety cover disengagement and needlestick injury reports.

    Product
    ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2303-2017·2017-06-14

    Arrow International Recalls Large-Bore CVC Kits Due to Needlestick Risk

    Arrow International is recalling specific large-bore central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2017·2017-06-14

    DePuy Synthes Orthopedic Instruments Recalled for Quality System Violations

    DePuy Orthopaedics is recalling 345 orthopedic instruments modified by U.S. distributors because they were made outside quality system regulations, potentially compromising safety and effectiveness.

    Product
    DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2017·2017-06-14

    ConvaTec Recalls Elongated Adult Non-Rebreather Oxygen Masks

    ConvaTec is voluntarily recalling specific lots of elongated adult non-rebreather oxygen masks. The recall was initiated in 2017 and is now terminated.

    Product
    Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2234-2017·2017-06-14

    ConvaTec Recalls Non-Rebreather Masks Due to Potential Valve Defect

    ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreather Masks due to a potential defect in the check valve. The recall covers units distributed in the US and internationally.

    Product
    Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2271-2017·2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk

    Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not li
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2017·2017-06-14

    ConvaTec Recalls Adult High Concentration Non-Rebreather Oxygen Masks

    ConvaTec, Inc. is voluntarily recalling specific lots of Adult High Concentration Non-Rebreather Oxygen Masks due to a Class II defect.

    Product
    Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2232-2017·2017-06-14

    ConvaTec Recalls Elongated Oxygen Masks Due to Defect

    ConvaTec is voluntarily recalling elongated oxygen masks in the US and 27 other countries. The recall was initiated by the firm and is classified as FDA Class II.

    Product
    Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2241-2017·2017-06-14

    ConvaTec Recalls Non-Rebreathing Masks Due to Potential Valve Defects

    ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreathing Masks with tubing. The recall is classified as Class II by the FDA.

    Product
    Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-2308-2017·2017-06-14

    Pinnacle Foods Recalls Aunt Jemima Mini Pancakes for Listeria Risk

    Pinnacle Foods is recalling Aunt Jemima Mini Pancakes, Blueberry Blast, due to potential Listeria monocytogenes contamination. The recall covers 5,371 units distributed nationwide.

    Product
    AUNT JEMIMA(R) MiNi pancakes, BLUEBERRY BLAST, NET WT 3.2 OZ, UPC 001960043567
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2017·2017-06-14

    ConvaTec Recalls Pediatric Oxygen Masks Due to Potential Defect

    ConvaTec is voluntarily recalling specific lots of pediatric oxygen masks. The recall addresses a potential defect in the high-concentration rebreather devices.

    Product
    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0886-2017·2017-06-14

    Dr. Reddy's Recalls Zenatane Capsules for Low Dissolution

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2251-2017·2017-06-14

    Teleflex Recalls Pediatric Nasal Cannulas Due to Incorrect Labeling

    Teleflex Medical is recalling 1,150 Hudson RCI Pediatric Nasal Cannulas because the box label says 'Pediatric' while the insert says 'Adult'.

    Product
    Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-2312-2017·2017-06-14

    Cook Medical Recalls Willscher Vas Reapproximator Plates Due to Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Reapproximator Plates because the reprocessing instructions lack sufficient detail for cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0883-2017·2017-06-14

    Dr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0895-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 10 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 5,260 pellets distributed nationwide.

    Product
    Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01
    Category
    Drug
    Distribution
    Distributed nationwide

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