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.

Which agencies issued them

101–200 of 896

  • 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-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-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 (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 (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-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 (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
  • LowFDA (Drugs)·D-1048-2016·2016-06-29

    Virtus Pharmaceuticals Recalls Leaking Prenatal/Postnatal Capsules

    Virtus Pharmaceuticals is recalling 1,586 bottles of VP-CH-PNV Prenatal/Postnatal capsules because the softgel capsules are leaking.

    Product
    VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1045-2016·2016-06-29

    Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Testing Failures

    Sandoz, Inc. is recalling Dicloxacillin Sodium Capsules because testing revealed out-of-specification results for a known impurity.

    Product
    Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2039-2016·2016-06-29

    Leica Biosystems Recalls CytoVision Systems Due to Windows 7 Activation Issues

    Leica Biosystems Richmond Inc. is recalling 283 CytoVision Image Analysis and Capture Systems because the Windows 7 operating system is improperly activated, appearing unlicensed.

    Product
    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1049-2016·2016-06-29

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to Labeling Error

    Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because an incorrect lot number appears on the case label.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1047-2016·2016-06-29

    Attix Pharmaceuticals Recalls Unregistered Mycophenolate Mofetil Bulk Powder

    Attix Pharmaceuticals is recalling Mycophenolate Mofetil bulk powder due to cGMP deviations and lack of FDA registration.

    Product
    Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1044-2016·2016-06-29

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Broken Dessicants

    Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate Sublingual Tablets because bottles may contain broken dessicants.

    Product
    Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalCPSC·16204·2016-06-28

    IKEA Recalls 29 Million Chests and Dressers Due to Tip-Over Hazard

    IKEA is recalling 29 million chests and dressers in the U.S. due to a serious tip-over hazard that has caused three child deaths and 17 injuries.

    Product
    Children's and adult chests and dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V473000·2016-06-28

    Strick Recalls 2015 and 2017 Tandem Axle Van Trailers for Brake Defect

    Strick Trailers is recalling specific 2015 and 2017 tandem axle van trailers because improperly machined spring brake valves may delay braking, increasing the risk of the trailer rolling away.

    Product
    STRICK — STRICK TANDEM AXLE VAN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V472000·2016-06-28

    Forest River Charleston Motorhomes Recalled for Throttle Sensor Defect

    Forest River is recalling 2014-2016 Charleston motorhomes because a throttle sensor defect may prevent the engine brake from activating, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER CHARLESTON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16755·2016-06-28

    Polaris Recalls Ranger 570 ROVs Due to Fire Hazard

    Polaris is recalling approximately 43,000 Ranger 570 recreational off-road vehicles because they can overheat and catch fire. Consumers should stop using these vehicles and contact Polaris for a free repair.

    Product
    Polaris Ranger 570 ROVs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V479000·2016-06-28

    Ford Recalls 2015-2016 Focus Electric Vehicles for Transmission Defect

    Ford is recalling 865 model year 2015-2016 Focus Electric vehicles because the transmission's differential pinion gear shaft may overheat and fracture, potentially causing a loss of motive power and park function.

    Product
    FORD — FORD FOCUS ELECTRIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V474000·2016-06-28

    Cheetah Chassis Recalls Trailers Due to Spring Brake Valve Defect

    Cheetah Chassis is recalling specific 2014-2016 trailers because improperly machined spring brake valves may delay braking, increasing the risk of the trailer rolling away.

    Product
    CHEETAH — CHEETAH FLATBED TRAILER, EXTENDABLE CHASSIS, BRIDGEMASTER CHASSIS, CURTAINSIDE FLATBED
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V476000·2016-06-28

    Great Dane Trailers Recall 2015-2017 Models Due to Brake Valve Defect

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

    Product
    GREAT DANE — GREAT DANE DRY FREIGHT VAN, REEFER, FLATBED TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V477000·2016-06-28

    Terex Recalls 2015-2016 Aerial Devices Due to Platform Tilt Risk

    Terex is recalling 2015-2016 HR, HRX, TC, and TCX aerial devices because poor welds on the platform leveling cylinder may cause the platform to tilt, risking occupant falls.

    Product
    TEREX — TEREX HRX, HR, TC, TCX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V478000·2016-06-28

    Newmar Recalls 2014-2016 Motorhomes Due to Throttle Pedal Sensor Defect

    Newmar is recalling 1,243 motorhomes because a throttle pedal sensor may fail, preventing the engine brake from activating and reducing braking ability.

    Product
    NEWMAR — NEWMAR DUTCH STAR, MOUNTAIN AIRE, LONDON AIRE, ESSEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V475000·2016-06-28

    Ford Recalls 2016 Explorer and F-150 for Seat Back Weld Defect

    Ford is recalling 2016 Explorer and F-150 vehicles with manual recline driver's seats because insufficient welds may compromise occupant restraint during a crash.

    Product
    FORD — FORD EXPLORER, F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V467000·2016-06-27

    Volvo Recalls 2013 VNM and VNL Trucks for Front Axle Defect

    Volvo is recalling 129 model year 2013 VNM and VNL trucks because certain front steer axles may fracture, increasing the risk of a crash.

    Product
    VOLVO — VOLVO VNM, VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V470000·2016-06-27

    John Evans Recalls 2016 Cheetah Flatbeds Due to Brake Drag Risk

    John Evans is recalling 2016 Cheetah tandem flatbed trailers because a defective brake actuator may cause brake drag, potentially leading to a wheel end fire.

    Product
    JOHN EVANS — JOHN EVANS CHEETAH TANDEM FLATBED
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V468000·2016-06-27

    Thor Motor Coach Recalls Motorhomes Due to Front Sway Bar Defect

    Thor Motor Coach is recalling 2016-2017 Venetian, Tuscany, and Palazzo motorhomes because front sway bar brackets may not fit properly, risking detachment and crashes.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR VENETIAN, TUSCANY, PALAZZO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V486000·2016-06-27

    Vermeer Recalls Trailers Due to Spring Brake Valve Defect

    Vermeer is recalling specific 2014-2016 trailers because improperly machined spring brake valves may delay braking, increasing the risk of the trailer rolling away.

    Product
    VERMEER — VERMEER HG4000, DT6, WC2500XL, TG5000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V471000·2016-06-27

    Harley-Davidson Recalls 2016 Motorcycles for Clutch Master Cylinder Defect

    Harley-Davidson is recalling 27,232 model year 2016 motorcycles because the clutch master cylinder may fail to disengage the clutch, increasing the risk of a crash.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FLHTP, FLHTCU, FLHTK, FXSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V465000·2016-06-27

    Forest River Recalls Motorhomes Due to Water Leak in Lighting Module

    Forest River is recalling specific 2015-2017 motorhomes because water may leak into the electrical module, causing exterior lights to fail and increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER SUNSEEKER, FORESTER, SOLERA, ISATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V469000·2016-06-27

    Thor Motor Coach Recalls 2014-2016 Tuscany Motorhomes for Brake Defect

    Thor Motor Coach is recalling 2014-2016 Tuscany motorhomes because a throttle sensor defect may prevent the engine brake from activating, increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH TUSCANY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·053-2016·2016-06-26

    Ghiringhelli Recalls Chicken Caesar Salad Due to Undeclared Allergens

    Ghiringhelli Specialty Foods is recalling approximately 2,444 pounds of Trader Giotto's Chicken Caesar Salad because the products contain undeclared soy, wheat, and fish, and are missing a shellfish warning.

    Product
    Ghiringhelli Brothers — Ghiringhelli Specialty Foods, Inc. Recalls Poultry Products Due To Mislabeling and Undeclared Allergens
    Category
    Food
    Distribution
    10 states
  • SevereUSDA FSIS·052-2016 EXP·2016-06-25

    U.S. Cado Holdings Recalls Imported Swai Fillets for Import Violations

    U.S. Cado Holdings is recalling approximately 27,995 pounds of imported frozen Swai fillets that entered U.S. commerce without meeting federal residue testing requirements.

    Product
    U.S. Cado Holdings, Inc. Recalls Imported Siluriformes Fish Products Distributed Without Meeting FSIS Requirements
    Category
    Food
    Distribution
    8 states
  • SevereNHTSA·16V461000·2016-06-24

    Chrysler Recalls 2015-2016 Vehicles for Transmission Pump Defect

    Chrysler is recalling specific 2015-2016 Town & Country, Grand Caravan, Journey, and ProMaster vehicles because a transmission pump may seize, causing loss of motive power and increasing crash risk.

    Product
    DODGE — DODGE, RAM, CHRYSLER GRAND CARAVAN, PROMASTER, JOURNEY, TOWN AND COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V463000·2016-06-24

    Entegra Aspire Motorhome Recalled for Brake Signal Defect

    Entegra Coach is recalling 2015-2016 Aspire motorhomes because the brake signal to towed devices may not deactivate, increasing crash risk.

    Product
    ENTEGRA — ENTEGRA ASPIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V464000·2016-06-24

    Volkswagen Recalls 2016 Models for Rear Child Door Lock Defect

    Volkswagen is recalling 2016 CC, Golf R, Tiguan, and e-Golf vehicles because vibrations may cause rear child door locks to disengage, allowing children to open doors.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN, GOLF R, CC, E-GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V462000·2016-06-24

    Entegra Aspire Motorhomes Recalled for Throttle Sensor Defect

    Entegra is recalling 2015-2016 Aspire motorhomes because a throttle sensor defect may prevent the engine brake from activating, increasing crash risk.

    Product
    ENTEGRA — ENTEGRA ASPIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V458000·2016-06-23

    Mitsubishi Recalls Vehicles for Front Control Arm Corrosion Risk

    Mitsubishi is recalling specific Lancer and Outlander models because front cross members may corrode, causing control arms to detach and increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER, LANCER WAGON, LANCER EVOLUTION, LANCER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E059000·2016-06-23

    Waterous Recalls Split-Shaft Transmission Shift Units for Emergency Vehicles

    Waterous is recalling specific Split-Shaft Transmission Shift Units used in emergency response vehicles. A damaged component may prevent operators from switching power output, potentially hindering fire suppression efforts.

    Product
    POWER TRAIN:MANUAL TRANSMISSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16201·2016-06-23

    3M Recalls Vented Hard Hats Due to Electric Shock Hazard

    3M is recalling about 7,500 vented hard hats sold online because they do not provide the advertised protection against electric shock.

    Product
    Vented hard hats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1891-2016·2016-06-22

    CareFusion Recalls AVEA Comprehensive Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Comprehensive ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1518-2016·2016-06-22

    Publix Deli Wheatberry Salad Recalled for Listeria Contamination Risk

    Publix Super Markets is recalling Wheatberry Salad kits due to potential Listeria monocytogenes contamination. The product was distributed to stores in six southeastern states.

    Product
    Publix Deli, Wheatberry Salad, sold in 3.5 oz clamshell, 1 lb Grab and Go kit, and Chef Select custom order behind the deli counter. Received at retail store as a 12.75 lbs kit. Ingredients are combined at retail store. Manufactured for Publix Supermarkets in Lakeland, FL
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1892-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V455000·2016-06-22

    Winnebago Recalls 2014-2016 Motorhomes Due to Throttle Sensor Defect

    Winnebago is recalling 2014-2016 Tour and Itasca Ellipse motorhomes because a throttle sensor defect may prevent the engine brake from activating, increasing crash risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA TOUR, ELIPSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1978-2016·2016-06-22

    Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling specific Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the cen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V457000·2016-06-22

    Forest River Recalls 2013-2016 XLR Toyhaulers for Axle Bolt Defect

    Forest River is recalling 2013-2016 XLR toyhaulers because improperly seated axle bolts may allow the axle to shift, increasing the risk of a crash.

    Product
    FOREST RIVER — FOREST RIVER XLR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1894-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Ventilators because a defective fuse on the TCA Board may fail, causing loss of power to the User Interface Module.

    Product
    TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V456000·2016-06-22

    Mack Recalls 2013 Pinnacle Trucks Due to Front Axle Fracture Risk

    Mack Trucks is recalling 2013 Pinnacle (CXU) trucks because improperly heat-treated front axles may fracture, increasing the risk of a crash.

    Product
    MACK — MACK PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1037-2016·2016-06-22

    Fresenius Kabi Recalls Sensorcaine Due to Glass Particulate Matter

    Fresenius Kabi is recalling specific lots of Sensorcaine injection because glass particulate matter was found in the sterile product.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1898-2016·2016-06-22

    CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect

    CareFusion is recalling AVEA Ventilator upgrade kits because an incorrect fuse may fail, causing loss of power to the User Interface Module.

    Product
    AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1033-2016·2016-06-22

    Hospira Recalls Vancomycin Hydrochloride Injection Due to Cardboard Particulate Matter

    Hospira Inc. is recalling specific lots of Vancomycin Hydrochloride for Injection due to the presence of cardboard particulate matter.

    Product
    Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1492-2016·2016-06-22

    Oasis Foods Creamy Liquid Fry Shortening Recalled for Foreign Material

    Oasis Trading Co. is recalling 2,360 containers of Oasis Foods Creamy Liquid Fry Shortening because the product was reported to contain high density polyethylene resin trim rings.

    Product
    Oasis Foods Creamy Liquid Fry Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc., Hillside, NJ 07205, UPC 7 32146 10540 9
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1979-2016·2016-06-22

    Navilyst Medical Recalls Xcela Hybrid PICC Catheters with Valve Technology

    Navilyst Medical is recalling 157 units of Xcela Hybrid PICC catheters because they lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2016·2016-06-22

    Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces the incidence of hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1500-2016·2016-06-22

    Oasis Trading Recalls Chef's Quality Creamy Liquid Fry Oil Due to Foreign Material

    Oasis Trading Co., Inc. is recalling 8,399 containers of Chef's Quality Creamy Liquid Fry Oil because the bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Chef's Quality Creamy Liquid Fry Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00482 9
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1487-2016·2016-06-22

    CSM Bakery Red Velvet Cake Recalled for Unlabeled Peanut Trace

    CSM Bakery Products is recalling 8-inch single-layer red velvet cakes because lab testing found trace amounts of peanuts, which were not declared on the label.

    Product
    8 " Single Layer Red Velvet Cake
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1478-2016·2016-06-22

    CSM Bakery Recalls Chick-fil-A Chocolate Chunk Cookies for Undeclared Peanut

    CSM Bakery Products NA is recalling specific batches of chocolate chunk cookies produced for Chick-fil-A due to undeclared peanut protein.

    Product
    Brill, New Cookie, Chocolate Chunk, No Thaw, 160-2.75 oz. Cookies, Net Weight 27.5 lbs. (12.47 kg), Produced for Chick-Fil-A, Inc., Manufactured by: CSM bakery Products NA, Inc., Tucker, GA 30084.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1449-2016·2016-06-22

    Cinnabon Caramel Pecan Cookies Recalled for Undeclared Peanut Allergen

    CSM Bakery Products NA is recalling Cinnabon Caramel Pecan cookies because they contain undeclared peanut protein, posing a risk to individuals with peanut allergies.

    Product
    Cinnabon Caramel Pecan, 3 oz. Cookie, Net Weight 23.45 lbs. (10.63 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1507-2016·2016-06-22

    Silver Source Canola Salad Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling 540 containers of Silver Source Canola Salad Oil due to the presence of high density polyethylene resin trim rings in the bottles.

    Product
    Silver Source Canola Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795427707
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1945-2016·2016-06-22

    Sysmex XN-Series Hematology Analyzers Recalled for Potential Elevated Values

    Sysmex Corporation is recalling XN-10 and XN-20 hematology analyzers due to a potential for elevated hemoglobin and impedance platelet count values.

    Product
    The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1953-2016·2016-06-22

    Zimmer Trabecular Metal Implants Recalled for Sterility Concerns

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouches used for sterile integrity.

    Product
    TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MONO TIB STR GRN SZ 5 17MM - 00588606517 TM MONO TIB STR GRN SZ 6 10MM - 00588606610 TM MONO TIB STR GRN SZ 6 12MM - 00588606612 TM MONO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1472-2016·2016-06-22

    CSM Bakery Products Recalls Frozen Cookie Dough for Undeclared Peanut

    CSM Bakery Products is recalling frozen pre-cut cookie dough because it contains undeclared peanut protein. Consumers should not eat the product.

    Product
    Chocolate Chip, TranSmart, Frozen Pre-cut Cookie Dough, Net Weight 22.5 lbs (10.22 kgs).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1469-2016·2016-06-22

    CSM Bakery Products Recalls Frozen Cookie Dough for Undeclared Peanut

    CSM Bakery Products is recalling specific lots of frozen pre-cut cookie dough because they contain undeclared peanut protein.

    Product
    Chocolate Chip with Colored Candy Pieces, Frozen Pre-cut Cookie Dough, Net Weight; 24.61 lbs/11.17 kgs. and 23.44 lbs/10.64 kgs.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1454-2016·2016-06-22

    CSM Bakery Recalls Frozen Macadamia Nut Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling frozen pre-cut Macadamia Nut Cookie Dough because it contains undeclared peanut protein.

    Product
    Macadamia Nut Cookie With White Drops, Frozen Pre-cut Cookie Dough, Net Weight: 23.44 lbs/10.64 kgs. And 24.61 lbs/1/16 kgs.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1475-2016·2016-06-22

    CSM Bakery Products Recalls Chocolate Chip Cookies Due to Undeclared Peanut

    CSM Bakery Products is recalling TranSmart Chocolate Chip Message Cookies because they contain undeclared peanut protein. Consumers with peanut allergies should not eat the product.

    Product
    TranSmart, 12 Chocolate Chip Message Cookie, 24/24 ounce chocolate chip cookies in Bakeable Plastic Pans with Domes, Net Weight 36 lbs/16.33 kg.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1523-2016·2016-06-22

    Harris Teeter Recalls 12 Count Sugar Cookies for Undeclared Peanut Allergen

    Harris Teeter is recalling 12 Count Sugar Cookies because they contain undeclared peanut protein. Consumers with peanut allergies should not eat these products.

    Product
    12 Count Sugar Cookies, UPC 0007203695601, 12 Ct (Pack 25/12 Ct)
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1959-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to a potential for polystyrene particulate presence.

    Product
    BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-1483-2016·2016-06-22

    CSM Bakery Recalls Frozen Oatmeal Raisin Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling frozen pre-cut oatmeal raisin cookie dough because it contains undeclared peanut protein.

    Product
    Oatmeal Raisin, Frozen Pre-cut Cookie Dough, Net Weight 23.44 lbs/10.63 kgs and 24.61 lbs (11.16 kgs)
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1975-2016·2016-06-22

    Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 568 Xcela PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central ve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1501-2016·2016-06-22

    Oasis Trading Recalls Chef's Quality Soybean Oil Due to Foreign Material

    Oasis Trading Co., Inc. is recalling Chef's Quality Soybean Oil because bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Chef's Quality Soybean Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: RD/JET LLC, 15-24 132nd Street, College Point, NY 11356, UPC 7 60695 00931 2
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1510-2016·2016-06-22

    Clight Drink Mix Recalled for Undeclared Soy Ingredient

    Mondelez Puerto Rico is recalling Clight drink mix products because they contain soy lecithin but do not declare soy on the label.

    Product
    Label reads in part as: "Clight***Naranja*** Orange***CALORIE FREE ARTIFICIALLY FLAVORED DRINK MIX***TWO PACKAGES IN ONE***MAKES 1 LITER***NET: 0.49 oz*** Distributed by: Mondelez Puerto Rico, LLC, Montehiedra Office Center Suite 801, 9615 Ave. Los Romeros, San Juan PR 00926-7037
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1473-2016·2016-06-22

    CSM Bakery Products Recalls Frozen Pre-cut Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling specific lots of frozen pre-cut chocolate chip cookie dough due to undeclared peanut protein.

    Product
    Chocolate Chip, Frozen Pre-cut Cookie Dough, Net Weight: 24.61 lbs/11.17 kgs and 23.44 lbs/10.63 kgs.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1527-2016·2016-06-22

    Spice Chain Recalls Rose Red Organic Ginger Products Due to Salmonella

    Spice Chain is recalling Rose Red Organic Ginger products after a positive Salmonella test. The recall covers 5,240 pounds distributed in New Jersey and South Carolina.

    Product
    Rose Red Organic Ginger Steam Filter Bag & Organic Ground Ginger Steam packaged in a poly-lined corrugated carton; 40 lb case bulk pack 40 lbs
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1463-2016·2016-06-22

    CSM Bakery Products Recalls TranSmart Sugar Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling TranSmart Sugar Cookie Dough because it contains undeclared peanut protein. Consumers should check their pantries for the specific batch numbers listed.

    Product
    TranSmart, Sugar Cookie Dough, 576/0.75 ounce cookies, Net Weight 27 lbs/12.26 kgs and 96/4 ounce cookies, Net Weight 24 lbs/10.9 kgs.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1485-2016·2016-06-22

    Fresh Express Chopped Asian Salad Recalled for Undeclared Allergens

    Fresh Express is recalling Chopped Asian salad bowls due to undeclared wheat, soy, and tree nuts (almonds). The product was distributed in Pennsylvania.

    Product
    The Farmers Market, Chopped Asian, Chopped Lettuce Blend, Roasted Chicken, Cherry Infused Cranberries & Almond Crunch, Square Noodles and Sesame Ginger Dressing, Net Wt. 6.25 oz. (177g), packed in clear rigid plastic containers, Fresh Express Incorporated, P.O. Box 80599, Salina
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1459-2016·2016-06-22

    CSM Bakery Recalls 7 Eleven Sugar Cookies Due to Undeclared Peanut

    CSM Bakery Products NA is recalling 7 Eleven Sugar Cookies because they contain undeclared peanut protein. The product was distributed in 19 states and Colombia.

    Product
    7 Eleven, Sugar Cookie (2.2 oz. Pucks), Net Weight 33 lbs (14.96 kg), Manufactured by; CSM Bakery, Tucker, GA 30084.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1444-2016·2016-06-22

    CSM Bakery Recalls 7 Eleven Chocolate Chunk Cookies for Undeclared Peanut

    CSM Bakery Products NA is recalling 7 Eleven Chocolate Chunk Cookies because they contain undeclared peanut protein. Consumers should not eat the product.

    Product
    7 Eleven, Chocolate Chunk Cookie (2.2 oz Pucks), Net Weight 33 lb (14.96 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1503-2016·2016-06-22

    Chef's Quality Canola Frying Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling Chef's Quality Canola Frying Oil because bottles were reported to contain a high density polyethylene resin trim ring.

    Product
    Chef's Quality Canola Frying Oil for Heavy Duty Frying, Net Wt. 35 LBS (15.87 KG), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00938 1
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1991-2016·2016-06-22

    CarboFix Recalls Piccolo Composite Tibia and Femoral Nailing System Guide Wires

    CarboFix Orthopedics is recalling 638 Piccolo Composite Ball Tip Guide Wires because the internal package was compromised, potentially affecting sterility.

    Product
    Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1999-2016·2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT S(20) - 3R scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT 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 infor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1992-2016·2016-06-22

    Med Tec Recalls Protura Robotic Couch System Software Due to Positioning Issues

    Med Tec Inc is recalling specific versions of Protura Robotic Couch System Software because non-sub-millimeter positioning is inconsistent with settings in split shift mode.

    Product
    Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1963-2016·2016-06-22

    Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate Presence

    Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices are used for internal bone fixation in the ankle and foot.

    Product
    BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-1474-2016·2016-06-22

    CSM Bakery Recalls Flik Chocolate Chip Cookies for Undeclared Peanut

    CSM Bakery Products NA is recalling Flik chocolate chip cookies because they contain undeclared peanut protein. The recall covers 34,525 cases distributed across 19 states and Colombia.

    Product
    FLIK, ZT Thin & Crispy Chocolate Chip Cookies, Contains 300 cookies weighing approximately 1.2 oz, Net Weight 22.5 lbs (10.2 kg), Manufactured for FLIK International, Rye Brook, NY 10573.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1950-2016·2016-06-22

    Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to a defect in the foil pouches used for sterile integrity.

    Product
    POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1961-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices were distributed in 15 states.

    Product
    BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states

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