The Recall Desk

Archive

September 2016 recalls

734 recalls were announced in September 2016.

What the numbers show

Critical
91
Severe
146
High
349
Moderate
125
Low
23

Of the 734 recalls this month scored against our rubric, 12% are Critical, 20% are Severe.

301–400 of 734

  • HighFDA (Devices)·Z-2801-2016·2016-09-21

    Siemens RAPIDLab 1245 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling 197 RAPIDLab 1245 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2119-2016·2016-09-21

    Hostess Donettes Powdered Mini Donuts Recalled for Peanut Allergen Mislabeling

    Hostess Brands is recalling Donettes Powdered Mini Donuts because they were manufactured with flour containing peanut allergen but are not labeled to contain peanuts.

    Product
    Hostess Donettes Powdered Mini Donuts, packaged in 9ct and 6-20ct bags of mini donuts, net wt. 10.5oz, UPC 888109150044; packaged in 9ct bag of mini donuts, net wt. 13.16oz, UPC 888109110246; packaged in 6ct single serve packages, net wt. 3oz, UPC 888109050047; the most responsib
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2786-2016·2016-09-21

    Howmedica Recalls AccuLIF PL Spinal Cages Due to Height Reduction

    Howmedica Osteonics Corp. is recalling AccuLIF PL spinal cages because some implants have shown a reduction in height greater than 1 mm after surgery.

    Product
    AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2010-2016·2016-09-21

    Sprouts Extraordinaire Recalls 5 lb Living Alfalfa Sprouts for Salmonella Risk

    Sprouts Extraordinaire is recalling 5 lb Living Alfalfa Sprouts due to potential Salmonella contamination. The product was distributed in Colorado and potentially other states.

    Product
    5 lb Living Alfalfa Sprouts. One package per case. Distributed by and/or Manufactured by Astec Ltd. dba Sprouts Extraordinaire
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-2129-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling all bread products due to undeclared soy and wheat allergens and missing ingredient labels.

    Product
    Rustic Roll; No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag. The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and labeled onl
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2816-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 150 units of SafeSet Reservoir kits with Transpac IV transducers due to a potential for leak.

    Product
    Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure int
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2167-2016·2016-09-21

    Mars Recalls Combos Cheddar Cheese Crackers for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Cheddar Cheese Crackers due to the potential for undeclared peanut residue.

    Product
    COMBOS CHEDDAR CHEESE CRACKER - Net Wt. 6.30 oz (178.6 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC USPC 41419420072
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2135-2016·2016-09-21

    Best Foods Recalls Deer Cumin Powder for Undeclared Peanut

    Best Foods NJ, Inc. is recalling Deer Cumin Powder because it may contain undeclared peanut. The product was distributed to several states.

    Product
    Deer Cumin Powder 7 oz.., UPC 714760027497 14 oz UPC 714760027503 Packed for: Best Foods Inc. Edison, NJ 08817
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-2090-2016·2016-09-21

    Country Home Bakers Recalls Cookie Dough Due to Metal Shavings

    Country Home Bakers is recalling All Natural Chocolate Chunk with Salty Caramel Cookie Dough because metal shavings were found in the product.

    Product
    Country Home Bakers, All Natural Chocolate Chunk with Salty Caramel Cookie Dough, Net Wt: 22.5 lbs (10.2 kg), Count: 240-1.5oz (43g) portions, Country Home Bakers, Atlanta, GA 30310, ready to bake.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-1499-2016·2016-09-21

    Aurobindo Recalls Pantoprazole Tablets Due to Foreign Tablet Presence

    Aurobindo Pharma USA is recalling specific bottles of Pantoprazole Sodium Delayed-Release Tablets because a foreign tablet was found inside the container.

    Product
    Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2788-2016·2016-09-21

    Howmedica Recalls AccuLIF PL Cages Due to Height Reduction

    Howmedica Osteonics Corp. is recalling AccuLIF PL Cages because some implants have shown a reduction in height greater than 1 mm.

    Product
    AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adj
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2787-2016·2016-09-21

    Howmedica Recalls AccuLIF PL Cages Due to Height Reduction

    Howmedica Osteonics Corp. is recalling AccuLIF PL Cages because some implants have shown a reduction in height greater than 1 mm after surgery.

    Product
    AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adju
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2164-2016·2016-09-21

    Snack Factory Pretzel Crisps Recalled for Undeclared Milk Allergen

    Baptista's Bakery is recalling Snack Factory Pretzel Crisps Srircha Lime because a consumer reported the presence of seasoned product containing undeclared milk.

    Product
    Snack Factory, Pretzel Crisps Srircha Lime, UPC 049508006060, 7.2 oz(204g).
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2126-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling bread products in Washington State due to undeclared soy and wheat and missing ingredient labels.

    Product
    Mini Roll Tondo No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag. The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and labeled o
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2802-2016·2016-09-21

    Siemens RAPIDLab 1260 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling 114 RAPIDLab 1260 Blood Gas Analyzers because patient names may be printed with data from different patients.

    Product
    RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2118-2016·2016-09-21

    Hostess Chocolate Frosted Mini Donuts Recalled for Peanut Allergen Mislabeling

    Hostess Brands is recalling Chocolate Frosted Mini Donuts because they were manufactured with flour containing peanut allergen but are not labeled to contain peanuts.

    Product
    Chocolate Frosted Mini Donuts, packaged in 6-20ct and 9ct bags of mini donuts as Hostess Donettes Frosted Mini Donuts, net wt. 11.25oz, UPC 888109150020; packaged in 9ct bags of mini donuts as Hostess Donettes Frosted Mini Donuts, net wt. 14.07oz, UPC 888109110239; packaged in 6c
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2128-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling Panino Tondo and Small Tondo Bread due to undeclared soy and wheat allergens and missing ingredient labels.

    Product
    Panino Tondo; and Small Tondo Bread; No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag. The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in pl
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2825-2016·2016-09-21

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 140 units of TP4 Kits with SafeSet Reservoirs due to a potential for leaks. The affected medical devices were distributed nationwide.

    Product
    TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by conve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2819-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 125 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2114-2016·2016-09-21

    Hostess Ding Dongs Recalled for Unlabeled Peanut Allergen

    Hostess Brands is recalling specific lots of Ding Dongs because they were made with flour containing peanut allergen but are not labeled to contain peanuts.

    Product
    Hostess Ding Dongs, chocolate cake with creamy filing, packaged in 10-ct multi-packs of individual cakes, net wt. 12.70oz (360 g), UPC 888109110611; and 6-ct. single serving fun size snack packs, individual pack net wt. 2.55 oz (72 g), UPC 888109010027. The responsible firm name
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2121-2016·2016-09-21

    Hostess Crunch Mini Donuts Recalled for Unlabeled Peanut Allergen

    Hostess Brands is recalling Crunch Mini Donuts because they were manufactured with flour containing peanut allergen but are not labeled to contain peanuts.

    Product
    Crunch Mini Donuts, packaged in 6-14-ct and 9-14-ct bags of mini donuts as Hostess Donettes Crunch Mini Donuts, net wt. 9.5oz, UPC 888109110642; packaged in 9-17-ct bags of mini donuts as Hostess Donettes Crunch Mini Donuts, net wt. 10.5oz, UPC 888109110659; packaged in 6ct singl
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2125-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling all bread products due to undeclared soy and wheat and missing labels.

    Product
    Frusta aka Italian Peasant Bread No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag. The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plas
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2206-2016·2016-09-21

    Sunrise Foods Recalls National Food Group Bourbon Sauce Due to E. Coli Risk

    Sunrise Foods Inc is recalling National Food Group Bourbon Sauce because the flour used in the product may be contaminated with E. Coli.

    Product
    National Food Group Bourbon Sauce 5.25 lb plastic bag Ingredients: Sugar, Oyster Flavored Sauce***All purpose Flour White Bleached Enriched***Dried Yeast. Contains: (Wheat) FOR INSTITUTIONAL USE ONLY Prepared for: National Food Group, Novi MI UPC 8 12177 01154 9
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2820-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 20 units of Bifurcated SafeSet Kits with 03mL Flush Devices due to a potential for leaks.

    Product
    Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2165-2016·2016-09-21

    Mars Recalls Combos Cheddar Cheese Pretzels for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Cheddar Cheese Pretzels due to the potential for undeclared peanut residue.

    Product
    COMBOS CHEDDAR CHEESE PRETZEL Net Wt. 6.30 oz (178.6 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419420058
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2207-2016·2016-09-21

    Sunrise Foods Spicy General Tso Sauce Recalled for E. Coli Risk

    Sunrise Foods is recalling Pre-Thickened Spicy General Tso Sauce because the flour used in the product may be contaminated with E. Coli.

    Product
    Sunrise Foods Pre-Thickened Spicy General Tso Sauce 5 lb plastic bag Ingredients: WATER, SOY SAUCE***SOYBEAN OIL, SWEET RICE***ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat) FOR INSTITUTIONAL USE ONLY SUNRISE FOODS, INC. COLS, OHIO 43204 UPC 8 12
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2813-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 90 units of Transpac IV Trifurcated Monitoring Kits due to a potential for leaks in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2238-2016·2016-09-21

    Haitai Recalls Matdongsan Peanut Crunch Snack for Undeclared Soy

    Haitai is recalling Matdongsan Peanut Crunch Snack because it contains undeclared soy lecithin. The recall affects specific lot codes distributed across 18 states.

    Product
    Matdongsan Peanuts Crunch Snack, Net Wt. 80g, 325g
    Category
    Food
    Distribution
    18 states
  • HighFDA (Food)·F-2256-2016·2016-09-21

    Misono Food Ltd Recalls Smoked Herring Roe for HACCP Violations

    Misono Food Ltd is recalling smoked herring roe produced in Norway because the foreign processor failed to meet HACCP requirements. The product was distributed to one retailer in New York City.

    Product
    Smoked Herring Roe, Salted and smoked herring roe, Net weight 0.152 (others may vary slightly), Produced by: Njardar AS 6094 Leinoy, Product of Norway
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2170-2016·2016-09-21

    Mars Recalls Combos Pizzeria Pretzels for Undeclared Peanut Residue

    Mars Chocolate North America is recalling specific 15-ounce Combos Pizzeria Pretzels due to the potential presence of undeclared peanut residue.

    Product
    COMBOS SNACKS PIZZERIA PRETZEL - 15 OZ -Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419780473
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2166-2016·2016-09-21

    Mars Recalls Combos Pizzeria Pretzels for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Pizzeria Pretzels due to potential undeclared peanut residue. The recall covers 183,678 cases distributed nationwide and abroad.

    Product
    COMBOS PIZZERIA PRETZEL - Net Wt. 6.30 Oz. (178.6 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419420065
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2138-2016·2016-09-21

    Gasco Industrial Recalls Soy Sauce Due to Undeclared Wheat

    Gasco Industrial is recalling 3,079 units of 1-gallon soy sauce sold in Puerto Rico and Saint Berthelemy because the product contains undeclared wheat.

    Product
    Label reads in part as: "Gasc¿ QUALITY BRAND***Salsa Soya (Soy Sauce)***Contenido Neto (Net Content): 1 Gal¿n (1 Gallon) (3.79 L)***GASCO INDUSTRIAL CORP. P.O. BOX 1360 GURABO, P.R. 00778 TEL. (787) 737-4000".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2197-2016·2016-09-21

    National Frozen Foods Recalls IQF Green Peas for Listeria Risk

    National Frozen Foods Corporation is recalling not-ready-to-eat IQF green peas due to potential Listeria monocytogenes contamination. The products are sold under various brands nationwide and in Canada and Japan.

    Product
    Not Ready to Eat, IQF green peas. Products' labels contains Cooking Instructions. Products are sold under various brands and various net weight. Bountiful Harvest Green Peas, item # 22486-11904, case UPC & label UPC 30822486119042 and 2248611904, net wt. 12/2.5 LB C&W
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2174-2016·2016-09-21

    Mars Recalls Combos Snacks Pizzeria Pretzel for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Snacks Pizzeria Pretzel due to potential undeclared peanut residue. The recall covers 183,678 cases distributed nationwide and to foreign markets.

    Product
    COMBOS SNACKS PIZZERIA PRETZEL Net Wt. 1.80 oz. (51 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419714751
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2805-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 420 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak. The affected units were distributed nationwide in the US.

    Product
    Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2823-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2831-2016·2016-09-21

    C.R. Bard Recalls Option-vm Urinary Catheters Due to Sterility Concerns

    C.R. Bard is recalling 274 units of Option-vm Urinary Catheters because an FDA inspection found them potentially nonsterile. The devices were distributed to 15 states.

    Product
    Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2810-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 1,420 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. 42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2807-2016·2016-09-21

    ICU Medical Recalls Transpac IV Bifurcated Kits Due to Leak Risk

    ICU Medical is recalling 10 units of Transpac IV Bifurcated Kits with SafeSet Reservoirs due to a potential for leaks.

    Product
    Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16268·2016-09-21

    Lenny Lamb Buckle Onbu Infant Carriers Recalled for Fall Hazard

    Lenny Lamb is recalling Buckle Onbu infant carriers because missing internal stitching creates a fall hazard for children. No injuries have been reported.

    Product
    Buckle Onbu infant carriers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2799-2016·2016-09-21

    Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens Healthcare Diagnostics Inc is recalling 6,786 RAPIDPoint 500 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2236-2016·2016-09-21

    Cookies and Cream Recalled for Undeclared Egg Allergen

    Chelsea Food Service is recalling Cookies and Cream produced for King Soopers because the label fails to declare the egg allergen.

    Product
    Cookies and Cream, Produced for King Soopers, 6.6 oz. Packaged: Plastic clam shell, Individual unit, King Soopers, Denver CO
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2796-2016·2016-09-21

    Merge Healthcare Recalls RadSuite Software Due to Missing Studies

    Merge Healthcare is recalling RadSuite software versions where studies may be missing from archives before watermarking.

    Product
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2812-2016·2016-09-21

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 760 Transpac IV Trifurcated Monitoring Kits because of a potential for leaks in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macrodrip (Pole Mount), Item No. 42650-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrava
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2275-2016·2016-09-21

    Ajinomoto Recalls Cheese Sticks Due to E. coli O121 Contamination Risk

    Ajinomoto Windsor is recalling specific cheese stick products because they may be contaminated with E. coli O121. The recall covers 2,962 cases distributed across multiple US states.

    Product
    Molly's Kitchen Hotzzarella Cheese Sticks, 12 lbs., Item No. 582648; Fred's Hotzzarella Cheese Sticks, 12lbs., Item No. 0204320.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-2817-2016·2016-09-21

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 110 units of Double Kit with SafeSet and 03mL Flush Device due to a potential for leak.

    Product
    Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2800-2016·2016-09-21

    Siemens RAPIDLab 1240 Blood Gas Analyzer Recalled for Patient Data Mismatch

    Siemens is recalling 144 RAPIDLab 1240 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2795-2016·2016-09-21

    T2 Biosystems Recalls T2Candida Cartridges Due to Invalid Results

    T2 Biosystems is recalling T2Candida Cartridges because they produced elevated levels of invalid results. The recall affects 6,864 units distributed to 17 states.

    Product
    T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). A qualitative T2 Magnetic Resonance (T2MR¿) assay for the direct detection of Candida species in EDTA human whole blood specimens.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2822-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 10 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical curre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2239-2016·2016-09-21

    Whole Foods Market Thai Shrimp Salad Recalled for Undeclared Allergens

    Whole Foods Market is recalling Thai Shrimp Salad in the Northeast region because it was mislabeled, containing undeclared salmon and pistachios.

    Product
    Whole Food Market Thai Shrimp Salad Serving Size 8 oz. Distributed by Whole Foods Market Englewood Cliffs NJ 07632 UPC 8-2510-00081
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2133-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling Tramezzino bread products in Washington State due to undeclared soy and wheat allergens and missing ingredient labels.

    Product
    Tramezzino - PAN 3 lbs. SLC Bread; Tramezzino - PAN 3 lbs. Whole Bread No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag. The 3lb designation is for dough weight, not net wt. Sliced brea
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2202-2016·2016-09-21

    molly&drew Beer Bread Mix Recalled for Potential E. coli O121 Contamination

    Big L Brands is recalling molly&drew Beer Bread Mix because an ingredient is potentially contaminated with E. coli O121.

    Product
    molly&drew The Beer Bread Company, Beer Bread Mix, NET WT. 19.75 OZ, UPC 8 55290 00300 8, molly & drew Sac City, IA. Packed in paper bags.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2210-2016·2016-09-21

    Kwik Trip Recalls Strawberry Parfaits for Undeclared Peanuts and Almonds

    Kwik Trip is recalling Kitchen Cravings Strawberry and Mixed Berry Parfaits because they may contain undeclared traces of peanuts or almonds.

    Product
    Kitchen Cravings Strawberry Parfait, Net Wt. 8.25 oz (234 g). UPC 39779-18435 Creamy Parfait Base, Strawberries with Sweetened Granola. Keep Refrigerated.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2827-2016·2016-09-21

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 150 units of Transpac IV Trifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2127-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling specific bread products due to undeclared soy and wheat allergens and missing ingredient labels.

    Product
    Palline Integrale; and Pane Integrale PAN 3 lbs. SLC Bread No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag. The 3lb designation is for dough weight, not net wt. Sliced breads are indiv
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1768-2016·2016-09-21

    Ultimate Nutrition Amino Gold Tablets Recalled for Undeclared Milk

    Ultimate Nutrition is recalling Amino Gold Tablets Super Whey Formula because the product contains undeclared milk, a major food allergen.

    Product
    ULTIMATE NUTRITION AMINO GOLD TABLETS SUPER WHEY FORMULA Dietary Supplement 1500 mg 325 tablets
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2220-2016·2016-09-21

    General Mills Recalls Flour Products Due to E. coli O121 Outbreak Link

    General Mills is recalling specific flour products due to a potential link to a multistate E. coli O121 outbreak, although the bacteria has not been found in the products.

    Product
    50lb Sysco Classic Hotel & Restaurant Flour Bleached Enriched Malted Unit UPC 34730-23936 Code Dates/Production Dates 17NOV5KC, 18NOV5KC 25lb Sysco All-Purpose Hotel & Restaurant Flour Bleached Enriched Malted Unit UPC 34730-23957 Code Dates/Production Dates 20NOV5KC,
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2219-2016·2016-09-21

    General Mills Recalls Flour Products Due to E. coli O121 Outbreak Link

    General Mills is recalling flour products due to a potential link to a multistate E. coli O121 outbreak, though the bacteria has not been found in the products or facility.

    Product
    25lb New Yung Wah Diamond Brand Hotel & Restaurant Enriched Bromated Bleached Flour Unit UPC 100-16000-50875 Code Dates/Production Dates 15NOV2015KC
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2211-2016·2016-09-21

    Kwik Trip Recalls Mixed Berry Parfaits for Undeclared Peanut Traces

    Kwik Trip is recalling Kitchen Cravings Mixed Berry Parfaits because they may contain undeclared traces of peanuts or almonds.

    Product
    Kitchen Cravings Mixed Berry Parfait, Net Wt. 8.25 oz (234 g). UPC 39779-18436 Creamy Parfait Base, Strawberries & Blueberries with Sweetened Granola. Keep Refrigerated.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2798-2016·2016-09-21

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling RAPIDPoint 405 Blood Gas Analyzers because patient names may be printed with results from a different patient.

    Product
    Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2113-2016·2016-09-21

    Hostess Chocodile Twinkies Recalled for Unlabeled Peanut Allergen

    Hostess Brands is recalling Chocodile Twinkies because the product was manufactured with flour containing peanut allergen but is not labeled to contain peanuts.

    Product
    Hostess Chocodile Twinkies, chocolate covered sponge cake with creamy filling, packaged in 9-ct multi-packs of individual cakes, net wt. 13.02 oz (396 g), UPC 888109110499; and 6-ct. single serving fun size snack packs, individual pack net wt. 2.89 oz (82 g), UPC 888109010492. T
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2213-2016·2016-09-21

    General Mills Recalls Multiple Flour Products Due to E. coli O121 Outbreak Link

    General Mills is recalling various flour products due to a potential link to a multistate E. coli O121 outbreak. The company states the bacteria has not been found in its products or facilities.

    Product
    2 lb Gold Medal All Purpose Flour Case UPC 000-16000-10720 Package UPC 000-16000-10710 Recalled Better If Used By Dates 25MAY2017KC, 26MAY2017KC, 27MAY2017KC, 28MAY2017KC, 29MAY2017KC, 30MAY2017KC, 31MAY2017KC, 01JUN2017KC, 02JUN2017KC, and 03JUN2017KC Expanded recall: 1
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2224-2016·2016-09-21

    Pictsweet Recalls Frozen Cut Green Beans for Possible Listeria Contamination

    The Pictsweet Company is recalling specific lots of frozen cut green beans due to possible Listeria monocytogenes contamination in bulk vegetable ingredients.

    Product
    Frozen cut green beans labeled as: 1. Kroger(R) Cut Green Beans, NET WT 32 OZ (2 LB) 907g, UPC1111081914 BEST IF USED BY: Feb 2016 through Oct 2017; with Mfg Code ### # K # # 6 units per case 2. Kroger(R) Cut Green Beans, NET WT 12 OZ. (340g), DISTRIBUTED BY THE KROGER CO.,
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1770-2016·2016-09-21

    Ultimate Nutrition Amino Gold Capsules Recalled for Undeclared Milk

    Ultimate Nutrition is recalling Amino Gold Capsules Super Whey Formula because the product contains undeclared milk, a major food allergen.

    Product
    ULTIMATE NUTRITION AMINO GOLD CAPSULES SUPER WHEY FORMULA Dietary Supplement, 1000 mg, 250 tablets; UPC: 0 99071 00140 5
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2806-2016·2016-09-21

    ICU Medical Recalls Transpac IV Trifurcated Kits Due to Leak Risk

    ICU Medical is recalling 250 units of Transpac IV Trifurcated Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Macrodrip, Item No. 42500-04 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2176-2016·2016-09-21

    Mars Recalls Combos Snacks Cheddar Cheese Pretzels for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Snacks Cheddar Cheese Pretzels due to potential undeclared peanut residue.

    Product
    COMBOS SNACKS CHEDDAR CHEESE PRETZEL - Net Wt. 1.80 OZ (51 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA 41419714713
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2832-2016·2016-09-21

    Circulatory Technology Recalls Bigger-Better-Bladder 2 Devices Due to Seal Leak

    Circulatory Technology Inc is recalling 20 units of the Bigger-Better-Bladder, TM 2 device because the seal between the balloon and housing may leak.

    Product
    The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal c
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-2218-2016·2016-09-21

    General Mills Recalls Gold Medal Flour Due to E. coli O121 Outbreak Link

    General Mills is recalling Gold Medal flour products due to a potential link to a multistate E. coli O121 outbreak, although the bacteria has not been found in the products.

    Product
    25 lb Gold Medal Hotel & Restaurant Bakers Self-Rising Enriched Flour Bleached Unit UPC 100-16000-14318 Code Dates/Production Dates 16NOV2015KC, 02DEC2015KC, 03DEC2015KC.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2818-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling 70 units of SafeSet Reservoir and blood sampling kits due to a potential leak.

    Product
    Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2152-2016·2016-09-21

    Fresh Smoked Trout Recalled for Potential Botulism Contamination

    Michel Cordon Bleu Inc. is recalling Fresh Smoked Trout With Herbs due to potential Clostridium botulinum contamination. The product was distributed in California.

    Product
    Michel Cordon Bleu, Inc. Fresh Smoked Trout With Herbs, sold in various sizes
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2140-2016·2016-09-21

    Bake'n Joy Sanding Sugar Recalled for Potential Metal Fragments

    Bake'n Joy Foods is recalling 16-lb pails of sanding sugar due to potential metal fragments from a supplier.

    Product
    Bake'n Joy Sanding Sugar Net Wt. 16 lbs. pail Product Number: 0209416
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-2139-2016·2016-09-21

    Gasco Industrial Recalls NuChef Soy Sauce Due to Undeclared Wheat

    Gasco Industrial is recalling 154 units of NuChef Soy Sauce because the product contains undeclared wheat. The recall affects Puerto Rico and Saint Berthelemy.

    Product
    Label reads in part as: "NuChef Soy Sauce***Contenido Neto (Net Content): 1 Gal¿n (1 Gallon) (128 fl. oz.)***P.O. Box 10718, San Juan PR 00922-0712 Tel. (787) 781-7950 Packed for Northwestern Selecta Made in USA***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2131-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling specialty sandwich breads due to undeclared soy and wheat and missing ingredient labels.

    Product
    Specialty Sandwich Bread No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag. The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2123-2016·2016-09-21

    Hostess Donettes Maple Glazed Mini Donuts Recalled for Peanut Allergen

    Hostess Brands is recalling Donettes Maple Glazed Mini Donuts because the product contains peanut allergen but is not labeled to contain peanuts.

    Product
    Hostess Donettes Maple Glazed Mini Donuts, packaged in 9-17-ct bagsof mini donuts, net wt. 10.50oz, UPC 888109111243; the most responsible firm name on the label is Hostess Brands LLC, Kansas City, MO 64141.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2244-2016·2016-09-21

    Gardner Pie Company Recalls Key Lime Pies Due to Peanut Contamination

    Gardner Pie Company is recalling 163 key lime pies sold in Ohio because the graham cracker crumbs used in the crust may contain peanut residue.

    Product
    Product is a 32-ounce Key Lime pie sold at the firm's retail outlet only. Pie is packed in a cardboard carton with an aluminum pie pan and a plastic dome lid. Retail pie is not labeled. Customers are provided the flavor of pie they select for purchase.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2175-2016·2016-09-21

    Mars Recalls Combos Pretzels for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Buffalo Blue Cheese Pretzels due to potential undeclared peanut residue.

    Product
    COMBOS SNACK BUFFALO BLUE CHEESE PRETZEL - Net Wt. 1.80 (51 g) oz Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419474303
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2116-2016·2016-09-21

    Hostess Zingers Vanilla cakes recalled for unlabeled peanut allergen

    Hostess Brands is recalling Zingers Vanilla cakes because they were made with flour containing peanut allergen but are not labeled as containing peanuts.

    Product
    Iced Vanilla cake with creamy filling, packaged as Hostess Zingers Vanilla in 10-ct multi-packs of individual cakes, net wt. 12.70oz (360 g), UPC 888109110598; 6-ct. single serving fun size snack packs, 3 cakes per pack net wt. 3.81 oz. (108g), UPC 888109010119 and 888109300029;
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2198-2016·2016-09-21

    National Frozen Foods Recalls Mixed Vegetables for Listeria Risk

    National Frozen Foods Corporation is recalling IQF Mixed Vegetables due to potential Listeria monocytogenes contamination. The products were distributed in the US, Canada, and Japan.

    Product
    Not Ready to Eat, IQF Mixed Vegetables. Products' labels contains Cooking Instructions. Products are sold under various brands and various net weight. Heinz Mixed Vegetables 02521-39698 14902521396989 4902521396982 12/1 KG Heinz Mixed Vegetables 02521-39698 14902521396
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2115-2016·2016-09-21

    Hostess Zingers Recalled for Unlabeled Peanut Allergen

    Hostess Brands is recalling Zingers cakes because they were made with flour containing peanut allergen but are not labeled to contain peanuts.

    Product
    Iced Devil's Food cake with creamy filling, packaged as Hostess Zingers in 10-ct multi-packs of individual cakes, net wt. 12.70oz (360 g), UPC 888109110581; 6-ct. single serving fun size snack packs, individual pack net wt. 2.55 oz (72 g), UPC 888109010027;with the responsible fi
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2130-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling Sourdough PAN 3 lbs. SLC Bread due to undeclared soy and wheat allergens and missing ingredient labels.

    Product
    Sourdough PAN 3 lbs. SLC Bread; No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag. The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plast
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2124-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling bread products due to undeclared soy and wheat allergens and missing ingredient labels.

    Product
    Ciros PAN Bread 3 lbs. SLC; No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag. The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic a
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2203-2016·2016-09-21

    China Garden Bourbon Sauce Recalled for Potential E. Coli Contamination

    Sunrise Foods Inc. is recalling China Garden Bourbon Sauce because the flour used in the product may be contaminated with E. Coli.

    Product
    China Garden Bourbon Sauce (for Chicken) 5.25 lb plastic bag Ingredients: SUGAR, OYSTER FLAVORED SAUCE***SWEET RICE, WATER, ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat). FOR INSTITUTIONAL USE ONLY SUNRISE FOODS, INC. COLS, OHIO 43204
    Category
    Food
    Distribution
    16 states
  • HighFDA (Food)·F-2122-2016·2016-09-21

    Hostess Donettes Glazed Mini Donuts Recalled for Unlabeled Peanut Allergen

    Hostess Brands is recalling Donettes Glazed Mini Donuts because the flour used contains peanut allergen, which is not listed on the label.

    Product
    Hostess Donettes Glazed Mini Donuts, packaged in 9-17-ct and 6-17-ct bags of mini donuts, net wt. 10.50oz, UPC 888109110659;the most responsible firm name on the label is Hostess Brands, LLC, Kansas City, MO 64141.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2168-2016·2016-09-21

    Mars Recalls Combos Pepperoni Crackers for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Pepperoni Crackers due to potential undeclared peanut residue. The recall covers 183,678 cases distributed nationwide and abroad.

    Product
    COMBOS PEPPERONI CRACKER - Net Wt. 1.70 oz. (48.2 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419420089
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2245-2016·2016-09-21

    Gardner Pie Company Recalls Cheesecakes Due to Peanut Contamination

    Gardner Pie Company is recalling 1,109 cheesecakes because the graham cracker crumbs used in the crust may contain peanut residue.

    Product
    Product is a 29-ounce/9" cheesecake packed in a cardboard carton in an aluminum pie pan with a plastic dome lid. Pies for further distribution are packed in a master case, 8 units per case. The brand name on the case is Gardner Pie Company Akron, OH. The ingredient statement an
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2205-2016·2016-09-21

    Sunrise Foods Recalls Jump Dark Teriyaki Sauce Due to E. Coli Risk

    Sunrise Foods Inc is recalling Jump Dark Teriyaki Sauce because the flour used in the product may be contaminated with E. Coli.

    Product
    Jump Dark Teriyaki Sauce .5 gallon plastic bag Ingredients: WATER, SUGAR, SOY SAUCE***ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat) FOR INSTITUTIONAL USE ONLY Prepared for Jump International HIllard, Ohio 43026 UPC 8 56460 00114 5
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2789-2016·2016-09-21

    Stryker Patella Assembly Instrument Recalled for Component Disassociation Risk

    Stryker Howmedica Osteonics is recalling 2,039 units of the Scorpio Patella Assembly Instrument because press-fit failures could cause clamping components and pins to disassociate.

    Product
    Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2042-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling Panzanella Italian Peasant Bread due to undeclared soy and wheat allergens and missing product labeling.

    Product
    Label reads in part "***Panzanella Bread Company Italian Peasant Bread 24 oz. ***INGREDIENTS: Unbleached enriched wheat flour (Niacin, reduced iron, thiamine mononitrate, riboflavin, frolic acid, enzyme, ascorbic acid [dough conditioner]), Sea Salt (Salt, magnesium carbonate) Ca
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2797-2016·2016-09-21

    Siemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Patient Data Mismatch

    Siemens is recalling 492 RAPIDPoint 400 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381 , 10339634
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2830-2016·2016-09-21

    C.R. Bard Recalls Option-vf Urinary Catheters Due to Sterility Concerns

    C.R. Bard is recalling 274 units of Option-vf Urinary Catheters because an FDA inspection found them to be potentially nonsterile.

    Product
    Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-2237-2016·2016-09-21

    SimplyNature Organic Chipotle Ranch Dressing Recalled for Undeclared Wheat

    Drews LLC is recalling SimplyNature Organic Chipotle Ranch Dressing because it contains undeclared wheat. The product was distributed in five states.

    Product
    SimplyNature Organic Chipotle Ranch Dressing, Net Wt. 12 FL OZ (354mL), UPC: 0 41498 21862 1
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2821-2016·2016-09-21

    ICU Medical Recalls Pediatric Pressure Transducer Kits Due to Leak Risk

    ICU Medical is recalling 20 Pediatric Kits with 30mL Flush Devices due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2041-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling all bread products due to undeclared soy and wheat allergens and missing ingredient labels.

    Product
    Caraway Multigrain PAN Bread 3 lbs. SLC; The 3lb designation is for dough weight, not net wt. No ingredient statement on label. No labeling agreement with consignees. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the prod
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2137-2016·2016-09-21

    Gasco Industrial Recalls Soy Sauce Due to Undeclared Wheat

    Gasco Industrial is recalling 1,146 gallons of soy sauce distributed in Puerto Rico and Saint Berthelemy because the product contains undeclared wheat.

    Product
    Label reads in part as: "BELCA***Soy Sauce***HECHO EN PUERTO RICO (Made in Puerto Rico)***Contenido Neto (Net Content): Un Gal¿n (one gallon)***128 fl. oz***DISTRIBUIDO POR (Distributed by): MISTER PRICE INC. SAN JUAN, PR 00936".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2120-2016·2016-09-21

    Hostess Donettes Double Chocolate Mini Donuts Recalled for Peanut Allergen

    Hostess Brands is recalling Donettes Double Chocolate Mini Donuts because the flour used contains peanut allergen, which is not listed on the label.

    Product
    Hostess Donettes Double Chocolate Mini Donuts, packaged in 9-ct bags of mini donuts, net wt. 11.25 oz, UPC 888109150037, the most responsible firm name on the label is Hostess Brands, LLC in Kansas City,MO 64141.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2169-2016·2016-09-21

    Mars Recalls Combos Pretzels for Potential Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Buffalo Blue Cheese Pretzels due to potential undeclared peanut residue.

    Product
    COMBOS BUFFALO BLUE CHEESE PRETZEL Net Wt.6.30 oz (178.6 g)Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 4141420119
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2172-2016·2016-09-21

    Mars Recalls Combos Cheddar Cheese Crackers for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Cheddar Cheese Crackers due to potential undeclared peanut residue.

    Product
    COMBOS SNACKS CHEDDAR CHEESE CRACKER - 15 OZ Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419780497
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2254-2016·2016-09-21

    Atlantic Spice Cranberry Health Mix Recalled for Listeria Risk

    Atlantic Spice Co. is recalling Cranberry Health Mix because it was processed on equipment used for product possibly contaminated with Listeria monocytogenes.

    Product
    Atlantic Spice Cranberry Health Mix, packaged in a 16 oz, clear plastic bag; #1947
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-2171-2016·2016-09-21

    Mars Recalls Combos Cheddar Cheese Pretels for Undeclared Peanut Residue

    Mars Chocolate North America is recalling Combos Cheddar Cheese Pretels due to potential undeclared peanut residue. The recall affects 183,678 cases distributed nationwide and abroad.

    Product
    COMBOS SNACKS CHEDDAR CHEESE PRETZEL - 15 OZ - Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419780480
    Category
    Food
    Distribution
    Distributed nationwide

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