The Recall Desk

Archive

June 2016 recalls

896 recalls were announced in June 2016.

What the numbers show

Critical
58
Severe
256
High
403
Moderate
156
Low
23

Of the 896 recalls this month scored against our rubric, 6% are Critical, 29% are Severe.

101–200 of 896

  • 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-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-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-2025-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 25 Biograph mCT Flow 64-4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 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-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 (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-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
  • 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
  • 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-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-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 (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 (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.…
    Category
    Medical Device
    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
  • 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·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·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 FLATBED TRAILER, DRY FREIGHT VAN, REFRIGERATED TRAILER
    Category
    Vehicle
    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·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
  • 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
  • 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 TCX, TC, HRX, HR
    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
  • 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·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·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·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
  • 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
  • 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
  • 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
  • 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
  • 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-1888-2016·2016-06-22

    CareFusion Recalls AVEA 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, 17310-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·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
  • SevereFDA (Devices)·Z-1899-2016·2016-06-22

    CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect

    CareFusion is recalling AVEA GDE upgrade kits because an incorrect fuse may fail, causing loss of power to the ventilator's user interface.

    Product
    AVEA GDE upgrade kit, 12284-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-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-1889-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

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

    Product
    AVEA Standard ventilator, 17311-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
  • 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 (Devices)·Z-1897-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling 922 AVEA Ventilators worldwide because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    Gas Delivery Engine (GDE)-refurbished, R16650A 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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1890-2016·2016-06-22

    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 with Compressor ventilator, 17312-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-1896-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

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

    Product
    Gas Delivery Engine (GDE), 16650A 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
  • SevereFDA (Devices)·Z-1893-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

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

    Product
    AVEA Standard with Compressor ventilator-refurbished, R17312-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
  • SevereFDA (Devices)·Z-1895-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

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

    Product
    Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 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 (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
  • SevereFDA (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…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2003-2016·2016-06-22

    Zimmer Dome Centric Shoulder Implant Component Recalled for Assembly Issues

    Zimmer GmbH is recalling 177 Dome Centric components from the Anatomical Shoulder System 2.0 because they may be difficult to disassemble during surgery, potentially causing delays or incomplete procedures.

    Product
    Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1480-2016·2016-06-22

    CSM Bakery Recalls 7-Eleven Oatmeal Raisin Cookies for Undeclared Peanut

    CSM Bakery is recalling 7-Eleven Oatmeal Raisin Cookies because they contain undeclared peanut protein. The product was distributed in 19 states and Colombia.

    Product
    7 Eleven, Oatmeal Raisin Cookie (2.2 oz. Pucks)/ Net Weight 33 lbs (14.96 kg), Made in the USA By: CSM Bakery, Inc., Tucker, GA 30084.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1947-2016·2016-06-22

    Cordis PRECISE RX Nitinol Stent System Recalled for Deployment Failure

    Cordis Corporation is recalling PRECISE RX Nitinol Stent Systems (Biliary) due to the inability to deploy the stent or partial deployment.

    Product
    Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1466-2016·2016-06-22

    CSM Bakery Recalls Mini Chocolate Chip Cookies with M&Ms for Undeclared Peanut

    CSM Bakery Products NA is recalling 34,525 cases of 0.5 oz. TranSmart Mini Chocolate Chip Cookies with M&Ms because the product contains undeclared peanut protein.

    Product
    0.5 oz. TranSmart, Mini Chocolate Chip Cookies with M&Ms, Net Weight 22.5 lbs (10.20 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1972-2016·2016-06-22

    Navilyst Medical Recalls Vaxcel PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 1,127 Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980 The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1522-2016·2016-06-22

    Harris Teeter Recalls Gourmet Cranberry Crunch Cookies Due to Undeclared Peanut

    Harris Teeter is recalling Gourmet Cranberry Crunch Cookies because they contain undeclared peanut protein. Consumers should stop eating the product and return it to the store.

    Product
    Gourmet Cranberry Crunch Cookies, UPC 0007203695600, 4 Ct (Pack 24/4 Ct)
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1960-2016·2016-06-22

    Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate

    Arthrex, Inc. is recalling 138 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, 16 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 (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 (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 (Food)·F-1493-2016·2016-06-22

    Masbia Canola Oil Recalled for Foreign Material in Bottles

    Oasis Trading Co. is recalling 1,200 containers of Masbia Canola Oil because bottles were found to contain high density polyethylene resin trim rings.

    Product
    Masbia Canola Oil, Net Wt. 35 LB (15.88), Distributed by Dependable Food Corp, Edison, NJ 08817, UPC 7 32146 50866 8
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1515-2016·2016-06-22

    Dessert Innovations II Recalls White Cupcakes Due to Undeclared Peanut

    Dessert Innovations II is recalling White Cupcakes with White Icing because they contain undeclared peanut protein. The products were distributed in Georgia and North Carolina.

    Product
    White Cupcakes with White Icing, UPC #10074865110102
    Category
    Food
    Distribution
    2 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-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…
    Category
    Food
    Distribution
    1 state
  • 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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2016·2016-06-22

    Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 105 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, IR-145 Kit, 6F-55cm, UPN H965457430, 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 venous system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1477-2016·2016-06-22

    CSM Bakery Chocolate Chip Cookies Recalled for Undeclared Peanut Allergen

    CSM Bakery Products NA is recalling 21-pound cases of Chocolate Chip Cookies due to undeclared peanut protein. The product was distributed across 19 U.S. states and Colombia.

    Product
    Chocolate Chip Cookie, Net Weight: 21 lbs (9.53 kgs).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1464-2016·2016-06-22

    CSM Bakery Products Recalls Mini Sugar Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling 0.5 oz. TranSmart Mini Sugar Cookie Dough because it contains undeclared peanut protein. The product was distributed in 20 US states and Colombia.

    Product
    0.5 oz. TranSmart, Mini Sugar Cookie Dough, Net Weight 22.5 lbs (10.20 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1990-2016·2016-06-22

    Stryker PowerPRO Cots Recalled for Smoke and High-Speed Retract Reports

    Stryker is recalling 770 PowerPRO ambulance cots due to reports of smoke from the foot end and unexpected high-speed retraction.

    Product
    Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1513-2016·2016-06-22

    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***Lim¿n*** Lemon ***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…
    Category
    Food
    Distribution
    1 state
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2016·2016-06-22

    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 potential issues with the foil pouches used for sterile integrity.

    Product
    REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D…
    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-1446-2016·2016-06-22

    CSM Bakery Recalls Unbaked Chocolate Chip Cookies Due to Undeclared Peanut

    CSM Bakery Products NA is recalling 34,525 cases of Unbaked Chocolate Chip Cookies because they contain undeclared peanut protein.

    Product
    ¿ Sheet Unbaked Message Cookie, 20/20 oz. Unbaked Chocolate Chip Cookies, Net Weight 25 lbs/11.34 kg.
    Category
    Food
    Distribution
    19 states
  • HighCPSC·16754·2016-06-22

    Ecovent Recalls Room Sensors Due to Electrical Shock Hazard

    Ecovent is recalling about 600 room sensors because the cover can come off, exposing high-voltage components and posing an electrical shock hazard.

    Product
    Ecovent room sensors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1465-2016·2016-06-22

    CSM Bakery Products Recalls TranSmart Sugar Cookies Due to Undeclared Peanut

    CSM Bakery Products is recalling TranSmart Sugar Cookies because they contain undeclared peanut protein. The recall covers 34,525 cases distributed across 20 U.S. states and Colombia.

    Product
    TranSmart, Sugar Cookie, 240 1.5 oz. Cookies, Net Weight: 22.5 lbs/10.21 kg.
    Category
    Food
    Distribution
    19 states

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