The Recall Desk

Archive

June 2016 recalls

896 recalls were announced in June 2016.

What the numbers show

Critical
58
Severe
216
High
442
Moderate
156
Low
24

Of the 896 recalls this month scored against our rubric, 6% are Critical, 24% are Severe.

1–100 of 896

  • SevereNHTSA·16V489000·2016-06-30

    Brenner Recalls 2015-2017 Liquid Tank Trailers Due to Brake Defect

    Brenner is recalling 2015-2017 Liquid Tank trailers because improperly machined spring brake valves may delay braking, increasing the risk of the trailer rolling away.

    Product
    BRENNER — BRENNER LIQUID TANK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V488000·2016-06-30

    Vermeer Recalls TR620 and TR626 Trailers Due to Brake Valve Defect

    Vermeer is recalling 2015-2016 TR620 and TR626 trailers because improperly machined spring brake valves may delay braking, increasing the risk of the trailer rolling away.

    Product
    VERMEER — VERMEER TR620, TR626
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V487000·2016-06-30

    Toyota Recalls Prius and Lexus CT Hybrid Vehicles for Air Bag Defect

    Toyota is recalling 2010-2012 Prius, Prius Plug-in Hybrid, and 2011-2012 Lexus CT Hybrid vehicles because a weld in the curtain shield air bag inflator may crack, causing parts to eject into the cabin.

    Product
    TOYOTA — TOYOTA, LEXUS PRIUS PLUG-IN HYBRID, PRIUS, CT HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V490000·2016-06-30

    Chrysler Recalls 2017 Pacifica Vehicles for Seat Belt Stow Clip Defect

    Chrysler is recalling 2017 Pacifica vehicles because a center overhead seat belt stow clip may fracture, preventing seat belt use and increasing injury risk in a crash.

    Product
    CHRYSLER — CHRYSLER PACIFICA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1550-2016·2016-06-29

    Chocolate Covered Twinkies Recalled for Undeclared Allergens

    The Caramel Factory, LLC. is recalling chocolate covered Twinkies and caramel icing due to undeclared eggs, milk, wheat, and soy.

    Product
    chocolate covered Twinkies
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-1567-2016·2016-06-29

    Dakota Style Sunflower Kernels Recalled for Listeria Contamination Risk

    Dakota Style, Inc. is recalling Roasted & Salted Sunflower Kernels because they may be contaminated with Listeria monocytogenes.

    Product
    Dakota Style Roasted & Salted Sunflower Kernels, Net Wt. 3.5 oz. plastic bag. UPC 84872-20172
    Category
    Food
    Distribution
    28 states
  • CriticalFDA (Food)·F-1564-2016·2016-06-29

    NatureBox Sunflower Kernels Recalled for Listeria Monocytogenes Risk

    NatureBox is recalling Cheddar and Onion Sunflower Kernels due to a supplier notification regarding Listeria Monocytogenes contamination.

    Product
    NatureBox Cheddar and Onion Sunflower kernels: 5 oz. (142g) customer stand up pouch. UPC: 8 54557 00531 1 Ingredients: Non GMO Sunflower kernels, Sunflower Oil, Sweet Onion and White Cheddar Seasoning Blend (cane sugar, onion and garlic powder, cheddar cheese powder {chedda
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1525-2016·2016-06-29

    NatureBox Country Ranch Sunflower Kernels Recalled for Listeria

    NatureBox is recalling Country Ranch Sunflower Kernels due to a supplier notification regarding Listeria monocytogenes. The product was sold nationwide online.

    Product
    NatureBox Country Ranch Sunflower kernels; 5 oz. (142g) customer stand up pouch. UPC: 8 52523 00535 8 Ingredients: Sunflower kernels, Sunflower Oil, Buttermilk Powder, Salt, Rice Syrup Solids, Onion and Garlic, Sour Cream Powder (cultured milk, nonfat milk), Tomato Powder,
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1549-2016·2016-06-29

    Candy and Baked Goods Recalled for Undeclared Allergens

    The Caramel Factory, LLC. is recalling Oreos, candy, baked goods, and caramel icing due to undeclared eggs, milk, wheat, and soy.

    Product
    Oreos (chocolate coated)
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-1565-2016·2016-06-29

    SunOpta Sunflower Kernels Recalled for Listeria Monocytogenes

    NatureBox, Inc. is recalling SunOpta Country Ranch Sunflower Kernels due to a supplier notification regarding Listeria Monocytogenes contamination.

    Product
    SunOpta Country Ranch Sunflower Kernels- 45lbs case 6075 lbs received (35 cases)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V482000·2016-06-29

    Ford Recalls 2016 Transit Connects for Brake Pump Contamination

    Ford is recalling 2016 Transit Connect vehicles because metallic debris in the brake pump may degrade electronic stability control, increasing crash risk.

    Product
    FORD — FORD TRANSIT CONNECT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1536-2016·2016-06-29

    Candy and Baked Goods Recalled for Undeclared Milk and Soy Allergens

    The Caramel Factory, LLC. is recalling sugar free milk chocolate peanut clusters, candy, baked goods, and caramel icing due to undeclared milk and soy allergens.

    Product
    sugar free milk chocolate peanut cluster
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1570-2016·2016-06-29

    Vending Nut Co. Recalls Sunflower Seeds for Listeria Risk

    Vending Nut Co. is recalling 10-pound bags of roasted sunflower seeds in Texas due to potential Listeria monocytogenes contamination.

    Product
    NUTS Vending Nut Co. 2222 Montgomery St. Ft. Worth, TX 76107 817-737-3071 www.vendingnut.com Sunflower Seeds Roasted & No Salt Net Wt. (160 oz) 10lb UPC: 0-98301-00006-5 in cardboard container.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1534-2016·2016-06-29

    Candy and Baked Goods Recalled for Undeclared Milk and Soy Allergens

    The Caramel Factory, LLC. is recalling white and dark chocolate peanut clusters, candy, baked goods, and caramel icing due to undeclared milk and soy.

    Product
    white and dark chocolate peanut clusters
    Category
    Food
    Distribution
    7 states
  • SevereNHTSA·16V484000·2016-06-29

    Wabash National Van Trailers Recalled for Spring Brake Valve Defect

    Wabash National is recalling 2015-2017 Van Trailers because improperly machined spring brake valves may delay braking, increasing the risk of the trailer rolling away.

    Product
    WABASH NATIONAL — WABASH NATIONAL VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1569-2016·2016-06-29

    Vending Nut Co Sunflower Seeds Recalled for Listeria Risk

    Vending Nut Co is recalling 12,000 pounds of roasted and salted sunflower seeds due to potential Listeria monocytogenes contamination.

    Product
    NUTS Sunflower Seeds Roasted & Salted Vending Nut Co. Fort Worth, Texas 76107 Net Wt. 16 oz. (1 LB.) 454g packaged in plastic bags
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1560-2016·2016-06-29

    Let's Talk Health Energizer Drink Mix Recalled for Undeclared Milk

    Let's Talk Health, Inc. is recalling specific lots of Pomegranate Energizer Drink Mix due to undeclared whey protein, which contains milk and soy lecithin.

    Product
    Let's Talk Health Energizer Drink Mix Pomegranate 0.3oz UPC #91131180525
    Category
    Food
    Distribution
    34 states
  • HighFDA (Devices)·Z-2044-2016·2016-06-29

    Fresenius CLiC Monitor Recall for Potential Hemodialysis Pump Stoppage

    Fresenius Medical Care is recalling 875 CLiC monitors used with 2008T hemodialysis machines because a frozen screen may cause the blood pump to stop.

    Product
    Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1526-2016·2016-06-29

    Sweet Earth Big Sur Breakfast Burrito Recalled for Undeclared Milk Allergen

    Sweet Earth Inc. is recalling Big Sur Breakfast Burritos because some units were packaged with Sana Cruz Burritos that contain milk, which is not declared on the Big Sur label.

    Product
    Big Sur Breakfast Burrito; A delicious blend of roasted potatoes & red peppers, smoked seitan and seasoned tofu. Net Wt. 7.0 oz. (198 g). Ingredients: Filling: Russet Potatoes, tofu (water, soybeans, Calcium sulfate, Calcium chloride, Sweet Earth Traditional Seitan (water,
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2017-2016·2016-06-29

    Siemens Biograph PET/CT Scanner Upgrade Recalled for Calibration Error

    Siemens Medical Solutions is recalling 2 Biograph TruePoint scanner upgrades because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic inf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1531-2016·2016-06-29

    Candy and Caramel Icing Recalled for Undeclared Milk and Soy Allergens

    The Caramel Factory, LLC. is recalling white and dark chocolate cashew turtles and tortoises, candy, baked goods, and caramel icing due to undeclared milk and soy.

    Product
    white and dark chocolate cashew turtles and tortoises
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1563-2016·2016-06-29

    Let's Talk Health Tox Elim Liquid Recalled for Undeclared Allergens

    Let's Talk Health is recalling 75 units of Tox Elim Liquid due to undeclared whey protein and soy lecithin, posing a risk to individuals with milk or soy allergies.

    Product
    Let's Talk Health Tox Elim Liquid 32oz. UPC #91131181119
    Category
    Food
    Distribution
    34 states
  • HighNHTSA·16V485000·2016-06-29

    Nissan Recalls 2016 Sentra Vehicles Due to Engine Harness Defect

    Nissan is recalling 1,522 model year 2016 Sentra vehicles because an engine room harness terminal pin may be too large, potentially causing the engine to stall or fail to start.

    Product
    NISSAN — NISSAN SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V481000·2016-06-29

    Newmar Recalls 2017 Motorhomes Due to Wiper and Headlight Defect

    Newmar is recalling 2017 Ventana and Dutch Star motorhomes because wipers may block the view or headlights may turn off, increasing crash risk.

    Product
    NEWMAR — NEWMAR VENTANA VL, VENTANA, DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1524-2016·2016-06-29

    Papa John's Recalls Oriental Salad Due to Listeria Risk

    Papa John's Salads and Produce is voluntarily recalling Oriental Salad with Sesame Ginger Dressing due to possible Listeria monocytogenes contamination.

    Product
    (Albertsons/Safeway/Basha Hometown Grocers) Oriental Salad with Sesame Ginger Dressing, Net Wt.10 oz.(284g), 24 pieces per case, UPC 78279602691; (Food 4 Less) Oriental Salad with Sesame Ginger Dressing, Net Wt. 13 oz. (369 g), UPC 78277602840
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1589-2016·2016-06-29

    Wicker's Black Label Steak Marinade Recalled for Undeclared Wheat

    Wicker's Food Products Inc. is recalling Black Label Steak Marinade because it contains undeclared wheat. The product was distributed in Arkansas and Tennessee.

    Product
    Wicker's Black Label Steak Marinade, 16 Fl. Oz. (473.28 mL), Ingredients: Soy Sauce (Water, Salt, Hydrolyzed Soy Protein, Corn Syrup, Caramel Coloring), Vinegar, Herbs and Spices
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2043-2016·2016-06-29

    Fujifilm Synapse PACS Software Recall for Image Display Failure

    Fujifilm Medical Systems is recalling 27 units of Synapse PACS software versions 4.4.000 through 4.4.020 because the software fails to display medical images, showing an error message instead.

    Product
    Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation So
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-1556-2016·2016-06-29

    Caramel Factory Caramel Icing Recalled for Undeclared Soy Allergen

    The Caramel Factory is recalling Caramel Icing because it contains undeclared soy, a major food allergen.

    Product
    The Caramel Factory (TM) Caramel Icing, NET WT. 22OZ, 1 LB. 6OZ. (622 grams) and 2.5 GAL bucket
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2047-2016·2016-06-29

    Ceg Enterprises Recalls Germ Terminator Toothbrush Sanitizers Due to Heat and Cord Issues

    Ceg Enterprises is recalling Germ Terminator GT100 toothbrush sanitizers due to reports of excessive heat, power cord discoloration, and suspected counterfeit UL labels.

    Product
    Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cyc
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1557-2016·2016-06-29

    Golden Gourmet Veggie Chips Recalled for Undeclared Milk Allergen

    Bickel's Snack Foods is recalling Golden Gourmet Veggie Chips because ranch-flavored chips containing milk were packed in plain bags.

    Product
    Golden Gourmet Snacks Veggie Chips; Net Wt. 12 OZ; Bickel's Snack Foods, Inc., York, PA 17404 Lot codes: 26SEP16 Z4D1 and 26SEP16 Z5D1
    Category
    Food
    Distribution
    29 states
  • HighNHTSA·16V480000·2016-06-29

    Kia Recalls 2016 Sorento Vehicles for Rear Suspension Weld Defect

    Kia is recalling 2016 Sorento vehicles because a rear suspension component may not be properly welded, which could break and increase the risk of a crash.

    Product
    KIA — KIA SORENTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2005-2016·2016-06-29

    Siemens Biograph mCT-X 4R PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 83 Biograph mCT-X 4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2016·2016-06-29

    Immuno-Mycologics Recalls Histoplasma Yeast Complement Fixation Antigen Due to Bacterial Contamination

    Immuno-Mycologics, Inc. is recalling 467 units of Histoplasma Yeast Complement Fixation Antigen Dilute (Lot 111WH3) due to bacterial contamination. The product was distributed nationwide to specific states.

    Product
    Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomyc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1566-2016·2016-06-29

    Trader Joe's Recalls Triple Ginger Brew Due to Bursting Bottle Risk

    Trader Joe's is recalling Triple Ginger Brew glass bottles because unopened bottles may burst. The recall covers 75,240 cases sold nationwide.

    Product
    Triple Ginger Brew, 25.4 FL OZ (750 mL) glass bottles, SKU 51857 Bottles are sold individually; there are 9 bottles per case
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2038-2016·2016-06-29

    Cell Marque Recalls SIOOA I Rabbit Monoclonal Antibody Lots

    Cell Marque is recalling specific lots of SIOOA I Rabbit Monoclonal Antibody due to unacceptable IHC test results. The affected units were distributed in the US and several international countries.

    Product
    SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test me
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1043-2016·2016-06-29

    Profarma Recalls 1% Clotrimazole Cream Due to Manufacturing Deviations

    Profarma Distributors LLC is recalling 79 tubes of 1% Clotrimazole cream due to CGMP deviations. The recall is voluntary and nationwide.

    Product
    1% Clotrimazol cream, 30 mg tube, UPC 501318644335
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2016-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling Biograph 6-4R TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic informa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2046-2016·2016-06-29

    Implant Direct Recalls InterActive Implant Open-Tray Transfers Due to Sizing Error

    Implant Direct is recalling 48 units of InterActive Implant Open-Tray Transfers because the wrong size was packaged, which may lead to oversized crown fabrication.

    Product
    6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible or maxilla. Open Tray transfers stay within the Impre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2009-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 46 Biograph 40 TruePoint PET/CT scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Product
    BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2024-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 12 Biograph mCT Flow 64-3R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2028-2016·2016-06-29

    Siemens Biograph mCT S(20) - 3R PET/CT Scanner Recall

    Siemens is recalling 143 Biograph mCT S(20) - 3R scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2041-2016·2016-06-29

    Siemens ADVIA Centaur Tnl-Ultra Assay Recalled for Biotin Interference

    Siemens Healthcare is recalling ADVIA Centaur Tnl-Ultra Assay kits because biotin in patient samples can alter test results by more than 10%.

    Product
    Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1040-2016·2016-06-29

    Profarma Recalls tabcin NOCHE Capsules Due to Manufacturing Deviations

    Profarma Distributors LLC is recalling 31 boxes of tabcin NOCHE capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    tabcin NOCHE; Capsules,12-count box, UPC 501008485033
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2042-2016·2016-06-29

    Surgical Specialties Recalls Sharpoint Polypropylene Suture Due to Contamination

    Surgical Specialties Corporation is recalling Sharpoint Polypropylene Blue Monofilament 9-0 USP suture because it may contain Black Nylon 9-0 suture.

    Product
    Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2019-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling two Biograph PET/CT scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Product
    BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2033-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT scanners recalled for calibration error risk

    Siemens is recalling 127 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2018-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error

    Siemens is recalling four Biograph TruePoint PET/CT scanners due to a potential for unexpected SUV values when non-Siemens phantoms are used for calibration.

    Product
    BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1046-2016·2016-06-29

    Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Test Failure

    Sandoz, Inc. is recalling specific lots of Dicloxacillin Sodium Capsules, 500mg, because testing revealed an out-of-specification result for a known impurity.

    Product
    Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2020-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling nine Biograph mCT Flow 20-3R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2006-2016·2016-06-29

    Siemens Biograph 16 TruePoint TV Recall for Calibration Error

    Siemens is recalling 36 Biograph 16 TruePoint TV scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2035-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error

    Siemens Medical Solutions is recalling four Biograph TruePoint PET/CT scanners due to a risk of unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2029-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling five Biograph TruePoint PET/CT scanners because using a non-Siemens phantom for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2015-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 49 Biograph PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic inform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2048-2016·2016-06-29

    Medtronic Recalls Two EverFiex Stents Due to Outer Box Mislabeling

    Medtronic is recalling two Protege EverFiex Self-expanding Peripheral Stent Systems from lot A164580 because the outer box size label may not match the device inside.

    Product
    EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2032-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 51 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2027-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 13 Biograph mCT Flow Edge-4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1041-2016·2016-06-29

    Profarma Recalls Vermox Tablets Due to Manufacturing Deviations

    Profarma Distributors LLC is recalling 163 boxes of Vermox Tablets 100 mg due to CGMP deviations. The recall is voluntary and nationwide.

    Product
    VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2014-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 16 Biograph TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2013-2016·2016-06-29

    Siemens Biograph 64 PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 15 Biograph 64 PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2031-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error

    Siemens Medical Solutions is recalling 100 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2010-2016·2016-06-29

    Siemens Biograph TruePoint CT/PET Scanner Upgrade Recalled for Calibration Error

    Siemens is recalling a Biograph TruePoint upgrade kit because using a non-Siemens phantom for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic informa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2011-2016·2016-06-29

    Siemens Biograph PET/CT Scanner Recall for Calibration Error Risk

    Siemens is recalling Biograph 6 TP scanners due to a potential for unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic informat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2012-2016·2016-06-29

    Siemens Biograph 6 TruePoint Scanners Recalled for Calibration Error Risk

    Siemens Medical Solutions is recalling 102 Biograph 6 TruePoint scanners due to a potential for unexpected SUV values when non-Siemens phantoms are used for calibration.

    Product
    BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1039-2016·2016-06-29

    Profarma Recalls tabcin ACTIVE M.R. Capsules Due to Manufacturing Deviations

    Profarma Distributors LLC is voluntarily recalling 42 boxes of tabcin ACTIVE M.R. Capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling three Biograph TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1042-2016·2016-06-29

    Profarma Recalls Vermox Tablets Due to Manufacturing Deviations

    Profarma Distributors LLC is recalling 254 boxes of Vermox Tablets 500 mg due to CGMP deviations. The recall is voluntary and nationwide.

    Product
    VERMOX Tablets 500 mg, 1-count box, UPC 501109900596
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2007-2016·2016-06-29

    Siemens Biograph 40 PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling five Biograph 40 PET/CT scanners due to a potential for unexpected Standardized Uptake Value (SUV) readings when non-Siemens phantoms are used for calibration.

    Product
    BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2026-2016·2016-06-29

    Siemens Biograph mCT Flow Edge-3R Recalled for Calibration Error

    Siemens is recalling two Biograph mCT Flow Edge-3R scanners due to a potential for unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2021-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 28 Biograph mCT Flow 20-4R PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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