The Recall Desk

Archive

August 2016 recalls

766 recalls were announced in August 2016.

What the numbers show

Critical
77
Severe
169
High
248
Moderate
235
Low
37

Of the 766 recalls this month scored against our rubric, 10% are Critical, 22% are Severe.

Which agencies issued them

101–200 of 766

  • HighFDA (Devices)·Z-2595-2016·2016-08-31

    Conmed Dual Dispersive Electrodes Recalled for Burn Risk

    Conmed is recalling Adult ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.

    Product
    Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2646-2016·2016-08-31

    Bovie Precise 360 Handpiece Recalled Due to Adhesive Bonding Defect

    Bovie Medical Corporation is recalling 95 units of the BVX-330BR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.

    Product
    BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1974-2016·2016-08-31

    Laxmi Nutkhhata Golden Raisins Recalled for Undeclared Sulfites

    House of Spices is recalling Laxmi Nutkhhata Golden Raisins because they contain undeclared sulfites, a major food allergen.

    Product
    LAXMI NUTKHHAT Golden Raisins, Net Wt. 200g (7 oz), Product of USA -- Distributed by House of Spice Flushing, NY
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2631-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Components for Passivation Issues

    Medtronic is recalling three units of Alpha total knee replacement femoral components because they may not have been passivated according to job traveler requirements.

    Product
    RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2354-2016·2016-08-31

    Alere INRatio PT/INR System Recalled for Inaccurate Warfarin Monitoring Results

    Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may show lower INR values than central laboratory tests, potentially affecting warfarin dosing.

    Product
    Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use): The Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio ¿ 2 Monitor and INRatio¿ 2 PT/INR test s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2657-2016·2016-08-31

    Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Defect

    Philips is recalling 30 Ingenuity Core CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scans.

    Product
    Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2642-2016·2016-08-31

    Ziehm Vision R Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling one Ziehm Vision R Mobile C-arm device because its radiation-warning timer and 3D-specific interval warning malfunction, preventing alerts until the unit is rebooted.

    Product
    Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2647-2016·2016-08-31

    Bovie Precise 360 Handpiece Recalled for Incomplete Tip Bonding

    Bovie Medical Corporation is recalling 95 units of the BVX-330NR Bovie Precise 360 Handpiece due to potential incomplete bonding of the angled tip.

    Product
    BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2360-2016·2016-08-31

    Alere INRatio2 PT/INR Monitoring System Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio2 PT/INR Monitoring Systems because they may report inaccurate INR results, potentially leading to incorrect anticoagulant dosing.

    Product
    Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2644-2016·2016-08-31

    Ziehm Vision2 Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling two Ziehm Vision2 mobile C-arm devices because the radiation-warning timer and 3D-specific interval warning malfunction, preventing alerts until the unit is rebooted.

    Product
    Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2604-2016·2016-08-31

    Innokas Medical Recalls CARESCAPE VC150 Vital Signs Monitors for Software Error

    Innokas Medical Oy is recalling 1,715 CARESCAPE VC150 Vital Signs Monitors because a software error may provide incorrect time data to measurements.

    Product
    CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2357-2016·2016-08-31

    Alere INRatio2 PT/INR Testing System Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio2 PT/INR Testing Systems because some patients showed significantly higher INR results in central laboratories than on the device.

    Product
    Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1950-2016·2016-08-31

    Montana Flour Recalls Organic White Flour for Undeclared Wheat

    Montana Flour & Grains, Inc. is recalling 100% Organic Unbleached White Flour because the label does not declare wheat, a major food allergen.

    Product
    100% Organic Unbleached White Flour, packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2637-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Tibial Tray Components

    Medtronic is recalling two units of Alpha total knee replacement tibial trays that may not have been passivated according to job traveler requirements.

    Product
    TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-1462-2016·2016-08-31

    Talon Compounding Pharmacy Recalls Human Chorionic Gonadotropin Injection Due to Sterility Concerns

    Talon Compounding Pharmacy is recalling 6,500 vials of Human Chorionic Gonadotropin Injection nationwide due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu, (m) 20,000 iu with B12, 10 mL sterile, dep
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2633-2016·2016-08-31

    Medtronic Alpha Total Knee Replacement Components Recalled for Passivation Defect

    Medtronic is recalling Alpha total knee replacement femoral components that may not have been passivated according to job traveler requirements.

    Product
    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2632-2016·2016-08-31

    Medtronic Recalls Total Knee Replacement Components for Passivation Defect

    Medtronic Sofamor Danek is recalling specific total knee replacement femoral components that may not have been passivated correctly.

    Product
    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2607-2016·2016-08-31

    Merz Recalls Radiesse Injectable Implant Due to Syringe Delivery Issues

    Merz North America is recalling 1,591 units of Radiesse (+) Lidocaine Injectable Implant because the product could not be expelled from the syringe or needle.

    Product
    Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2628-2016·2016-08-31

    GE OEC UroView 2800 Fluoroscopic X-Ray System Recalled for Monitor Firmware Issue

    GE OEC Medical Systems is recalling 47 OEC UroView 2800 fluoroscopic x-ray systems because a firmware issue may cause the LCD workstation monitor to appear dark with no video displayed.

    Product
    OEC UroView 2800, fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2654-2016·2016-08-31

    Philips Brilliance BigBore CT Scanner Recalled for Image Reconstruction Error

    Philips is recalling 24 Brilliance BigBore CT scanners because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.

    Product
    Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2625-2016·2016-08-31

    Siemens CT Scanner Recall Due to Contrast Injection Failure

    Siemens is recalling two CT scanners where a software error prevents contrast agent injection during automatic scans, resulting in failed examinations.

    Product
    SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2656-2016·2016-08-31

    Philips Brilliance CT 16 Power Software Defect Recall

    Philips is recalling 50 Brilliance CT 16 Power systems due to a software defect that may cause planned anatomy to be cut off in images, potentially requiring a rescan.

    Product
    Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1470-2016·2016-08-31

    Teva Recalls Amoxicillin Oral Suspension Due to Potency Issues

    Teva North America is recalling Amoxicillin for Oral Suspension because stability testing showed the drug was superpotent.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1967-2016·2016-08-31

    Pleasant Hill Ovens Cheese & Berries Danish Recalled for Undeclared Colors

    Northern Tier Bakery is recalling Cheese & Berries Danish pastries due to possible mislabeling and undeclared food colors Blue #1 and Red #40.

    Product
    The Cheese & Berries Danish was labeled Pleasant Hill Ovens, Cheese Danish, Artificial Flavored, Net WT 5.0 OZ (142 g), UPC 7 63913 13003 4.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2600-2016·2016-08-31

    Integra LifeSciences Recalls QWIX Compression Screws Due to Labeling Error

    Integra LifeSciences is recalling QWIX Compression Screws because the product labeling incorrectly identifies them as compression screws rather than positioning screws.

    Product
    Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2629-2016·2016-08-31

    GE OEC 9800 Fluoroscopic X-Ray System Recalled for Monitor Firmware Issue

    GE OEC Medical Systems is recalling 47 OEC 9800 fluoroscopic x-ray systems because a firmware issue may cause the LCD workstation monitors to appear dark with no video displayed.

    Product
    OEC 9800, fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2624-2016·2016-08-31

    Siemens CT Scanner Recall Due to Contrast Injection Failure

    Siemens is recalling one SOMATOM Definition AS CT scanner because a software error prevents the automatic injection of contrast agent during scans.

    Product
    SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2636-2016·2016-08-31

    Medtronic Recalls Tibial Tray Components for Total Knee Replacement

    Medtronic is recalling three units of tibial tray components for total knee replacement because they may not have been passivated according to requirements.

    Product
    TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2605-2016·2016-08-31

    Panacea Air Pro Mattress Control Unit Recalled for Firmware Issue

    American National Mfg Inc is recalling 31 Panacea Air Pro Mattress Control Units due to a firmware problem that may affect the device's firmness range.

    Product
    Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2653-2016·2016-08-31

    Philips Brilliance CT Big Bore Oncology Software Recall

    Philips is recalling 33 Brilliance CT Big Bore Oncology systems due to a software defect that may cause planned anatomy to be cut off in gated helical CT images.

    Product
    Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2652-2016·2016-08-31

    Philips Brilliance 64 CT Scanner Recalled for Image Reconstruction Errors

    Philips is recalling 283 Brilliance 64 CT scanners because a software update can cause planned anatomy to be cut off in images, potentially requiring a rescan.

    Product
    Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2659-2016·2016-08-31

    Novarad NovaPACS Software Recalled for Prematurely Released Pop-up Screen

    Novarad Corporation is recalling NovaPACS software versions 8.4.7, 8.5.3, and 8.5.6 due to a prematurely released pop-up screen.

    Product
    NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2606-2016·2016-08-31

    Encore Medical Recalls Cobalt HV Bone Cement Due to Packaging Mislabeling

    Encore Medical is recalling 866 units of Cobalt HV Bone Cement because the outer packaging incorrectly indicated the product contained Gentamicin, an antibiotic it does not contain.

    Product
    Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2655-2016·2016-08-31

    Philips Brilliance 16 CT Scanner Recalled for Image Reconstruction Defect

    Philips Medical Systems is recalling 192 Brilliance 16 CT scanners because a software upgrade can cause planned anatomy to be cut off in images, potentially requiring a rescan.

    Product
    Brilliance 16, Model number 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2626-2016·2016-08-31

    Siemens SOMATOM Definition Edge CT Systems Recalled for Injector Failure

    Siemens is recalling four CT systems because a software error prevents the contrast agent injector from starting in automatic or coupled modes.

    Product
    SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Drugs)·D-1464-2016·2016-08-31

    Stratus Pharmaceuticals Recalls Remeven Cream Due to Crystallization

    Stratus Pharmaceuticals is recalling Remeven Cream because the product has crystallized. The recall covers specific lots of 5.0 oz and 9.0 oz tubes.

    Product
    Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1469-2016·2016-08-31

    Akorn Recalls Desoximetasone Gel Due to Impurity Specification Failure

    Akorn, Inc. is recalling Desoximetasone Gel USP, 0.05%, because the product failed impurity specifications at the 9-month stability time point.

    Product
    Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1465-2016·2016-08-31

    Exact-Rx Recalls Urea Cream Due to Crystallization

    Exact-Rx Inc. is recalling specific lots of Urea (50% Urea in a Cream Base) because crystals formed in the product.

    Product
    Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1471-2016·2016-08-31

    Actavis Recalls Acetasol HC Otic Solution Due to Impurity Failure

    Actavis Inc is recalling 672 bottles of Acetasol HC otic solution because stability testing showed an out-of-specification related compound at the 12-month time point.

    Product
    Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2601-2016·2016-08-31

    Siemens RAPIDPoint 500 Software Upgrade Kit Recalled for Uncleared Mode

    Siemens is recalling 76 RAPIDPoint 500 software upgrade kits because some include a dialysate mode not cleared for shipment in the United States.

    Product
    Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1472-2016·2016-08-31

    Actavis Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities

    Actavis Inc. is recalling 2,543 bottles of Hydrocortisone and acetic acid otic solution because stability testing showed out-of-specification results for a related compound.

    Product
    Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·16V627000·2016-08-30

    Triple E Recalls 2016 Unity Motorhomes Due to Showerhead Defect

    Triple E is recalling 2016 Unity motorhomes because a defective showerhead can lower into the sink, potentially syphoning waste water into the fresh water supply.

    Product
    TRIPLE E — TRIPLE E UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V626000·2016-08-29

    KME Fire Trucks Recalled for Potential Driveshaft Failure

    Kovatch Mobile Equipment is recalling 56 KME fire trucks because replacement driveshafts may twist and fail, potentially immobilizing the vehicle.

    Product
    KME — KME PREDATOR SS PUMPER, FDNY PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E069000·2016-08-29

    Idle Free Systems Recalls Auxiliary Power Units Due to Fire Risk

    Idle Free Systems is recalling 507 Auxiliary Power Units with Reefer-type trailer Link Kits manufactured between 2010 and 2016. The battery positive cable may short to ground, increasing the risk of a fire.

    Product
    ELECTRICAL SYSTEM:WIRING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·075-2016·2016-08-26

    WFSP Foods Recalls Pork and Chicken Sausage Due to Undeclared Milk Allergen

    WFSP Foods LLC is recalling approximately 18,672 pounds of Land O Frost sausage products because the packaging fails to declare milk, a known allergen.

    Product
    WFSP Foods LLC — WFSP Foods, LLC Recalls Pork and Chicken Sausage Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V625000·2016-08-26

    Horton Ambulances Recalled for Air Conditioner Wiring Fire Risk

    Halcore Group is recalling 2013-2016 Horton ambulances because a poorly sealed air conditioner wire harness allows water entry, creating a risk of electrical fire.

    Product
    HORTON AMBULANCE — HORTON AMBULANCE 453, 457, CHANGE OVER, 623
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V624000·2016-08-26

    Midwest Fire Recalls 2016-2017 All-Poly Fire Trucks for Transmission Defect

    Midwest Fire is recalling 2016-2017 All-Poly 2500 and 3000 series fire trucks because a transmission component may fail, preventing the vehicle from pumping water.

    Product
    MIDWEST — MIDWEST ALL-POLY 3000 SERIES, ALL-POLY 2500 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V623000·2016-08-26

    Tiffin Allegro Recall: Driver-Side Wiper Arm May Break

    Tiffin is recalling 2017 Allegro Open Roads because the driver-side wiper arm may break, reducing visibility and increasing crash risk.

    Product
    TIFFIN — TIFFIN ALLEGRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16253·2016-08-25

    Whirlpool Recalls Microwave Hood Combinations Due to Fire Hazard

    Whirlpool is recalling about 15,200 microwave hood combinations because internal arcing can ignite plastic components, posing a fire hazard.

    Product
    Whirlpool brand microwave hood combinations
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V621000·2016-08-25

    Ford Recalls 2013-2015 Taurus, Flex, MKS, MKT for Fuel Pump Defect

    Ford is recalling 2013-2015 Taurus, Flex, MKS, and MKT vehicles because a fuel pump component may overheat, causing the engine to stall or preventing the vehicle from starting.

    Product
    LINCOLN — LINCOLN, FORD MKS, FLEX, MKT, TAURUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16252·2016-08-25

    Cree Recalls LED T8 Lamps Due to Overheating and Burn Hazard

    Cree is recalling LED T8 replacement lamps that can overheat and melt, posing a burn hazard. No injuries have been reported.

    Product
    Cree® LED T8 Replacement Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V622000·2016-08-25

    Bison Recalls 2015-2016 Horse Trailers Due to Missing Battery Fuse

    Bison Coach is recalling 654 model year 2015-2016 horse trailers because a missing inline fuse on the battery cable could cause overheating and fire during an electrical short.

    Product
    BISON — BISON TRAIL HAND, RANGER, PREMIERE, LAREDO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16251·2016-08-25

    M&M's Branded Jewelry Recalled for Lead Content Violations

    Mars Retail Group is recalling M&M's-branded jewelry due to high lead levels. Consumers should stop using the items and return them for a refund.

    Product
    M&M'S®-branded jewelry
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V620000·2016-08-25

    Seagrave Recalls Marauder II Fire Trucks Due to Transmission Defect

    Seagrave is recalling 28 Marauder II fire trucks because a transmission component may fail, preventing the vehicle from pumping water at fire scenes.

    Product
    SEAGRAVE — SEAGRAVE MARAUDER II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·074-2016·2016-08-25

    Sentry Foods Recalls Frozen Chicken Entrées Due to Foreign Matter

    Sentry Foods is recalling approximately 21,570 pounds of frozen chicken entrées that may contain glass or hard plastic. The products were shipped to retail locations in Indiana, Texas, and Pennsylvania.

    Product
    Sentry Foods Recalls Frozen Chicken EntrÇes Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1927-2016·2016-08-24

    Nu Life Market Sunflower Spread Recalled for Listeria Contamination Risk

    Nu Life Market LLC is recalling Sun Life Natural Sunflower Spread because it may be contaminated with Listeria monocytogenes.

    Product
    Sun Life Natural Sunflower Spread in clear plastic jar with brown plastic lid, Net Wt. 12 oz., UPC 855881003370. The responsible name on the label is Nu Life Market, LLC, Scott City, KS.
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1933-2016·2016-08-24

    HelloFresh Recalls Lemony Pan-Seared Chicken Meal Due to Listeria Risk

    HelloFresh is recalling Lemony Pan-Seared Chicken with Pesto Potato Salad and Peas due to possible Listeria monocytogenes contamination.

    Product
    Lemony Pan-Seared Chicken with Pesto Potato Salad and Peas
    Category
    Food
    Distribution
    28 states
  • CriticalFDA (Food)·F-1935-2016·2016-08-24

    HelloFresh Recalls Lamb-Stuffed Zucchini Due to Listeria Risk

    HelloFresh is recalling 1,258 pounds of Nir's Lamb-Stuffed Zucchini with Spiced Lentil Stew due to possible Listeria monocytogenes contamination.

    Product
    Nir's Lamb-Stuffed Zucchini with Spiced Lentil Stew
    Category
    Food
    Distribution
    28 states
  • CriticalFDA (Food)·F-1945-2016·2016-08-24

    Oregon Potato Company Recalls Frozen Yellow Onion Dice for Listeria Risk

    Oregon Potato Company is voluntarily recalling specific lots of frozen yellow onion dice due to potential Listeria monocytogenes contamination.

    Product
    IQF 1/4 x 1/4 Yellow Onion Dice, item number 102654, bulk cases, net wt. 40 lbs. Onion 1/4 x1/4 Dice, Item number 103205, bulk cases, net wt. 45 lbs.
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Food)·F-1928-2016·2016-08-24

    Nu Life Sunflower Spread Recalled for Listeria Contamination Risk

    Nu Life Market is recalling Sun Life Natural Sunflower Spread with Maple due to potential Listeria monocytogenes contamination in roasted sunflower kernels.

    Product
    Sun Life Natural Sunflower Spread with Maple in clear plastic jar with brown plastic lid, Net Wt. 12 oz.., UPC 855881003370. The responsible name on the label is Nu Life Market, LLC, Scott City, KS.
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1924-2016·2016-08-24

    Greenland Trading Recalls Al Rasheed Sardines Due to Botulism Risk

    Greenland Trading Corp is recalling Al Rasheed Sardines due to potential C. botulinum contamination. The product was distributed in seven states.

    Product
    Al Rasheed Sardine Item #4017 Label not available - NYSDAM sampling.
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Devices)·Z-2533-2016·2016-08-24

    Baxter Recalls VASCU-GUARD Patches Due to Bleeding Reports

    Baxter Healthcare is recalling VASCU-GUARD Peripheral Vascular Patches due to postmarketing reports of intraoperative and postoperative bleeding, including one fatal outcome.

    Product
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1934-2016·2016-08-24

    HelloFresh Recalls Seared Steak Meal Due to Listeria Risk

    HelloFresh is recalling Seared Steak with Spring Veggie Succotash and Mint-Chive Pesto due to possible Listeria monocytogenes contamination.

    Product
    Seared Steak with Spring Veggie Succotash and Mint-Chive Pesto
    Category
    Food
    Distribution
    28 states
  • CriticalFDA (Food)·F-1929-2016·2016-08-24

    Sun Life Natural Sunflower Spread Recalled for Listeria Risk

    Nu Life Market LLC is recalling Sun Life Natural Sunflower Spread with Chocolate due to potential Listeria monocytogenes contamination.

    Product
    Sun Life Natural Sunflower Spread with Chocolate in clear plastic jar with brown plastic lid, Net Wt. 12 oz.., UPC 855881003370. The responsible name on the label is Nu Life Market, LLC, Scott City, KS.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1940-2016·2016-08-24

    Oregon Potato Company Recalls Frozen Yellow Onion Dice for Listeria Risk

    Oregon Potato Company is voluntarily recalling IQF 3/8" Un-Blanched Yellow Onion Dice due to potential Listeria monocytogenes contamination.

    Product
    IQF 3/8" Un-Blanched Yellow Onion Dice, Frozen, item number 103349, bulk cases, net wt. 45 lbs.
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Food)·F-1936-2016·2016-08-24

    Domino Pure Cane Granulated Sugar Recalled for Metal Fragments

    Domino Foods is recalling 50 lb bags of Pure Cane Large Grain Granulated Sugar due to the presence of metal fragments.

    Product
    Domino PURE CANE LARGE GRAIN GRANULATED SUGAR, NET WT 50 LB (22.67 kg), Distributed by Domino Foods, Inc., Yonkers, NY 10705
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1941-2016·2016-08-24

    Oregon Potato Company Recalls Frozen Yellow Onion Dice for Listeria Risk

    Oregon Potato Company is voluntarily recalling IQF 3/4" Yellow Onion Dice due to potential Listeria monocytogenes contamination.

    Product
    IQF 3/4" Yellow Onion Dice, Frozen, item number 101430, bulk tote, net wt. 1200 lbs.
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Food)·F-1939-2016·2016-08-24

    Oregon Potato Company Recalls Frozen Yellow Onion Strips for Listeria Risk

    Oregon Potato Company is voluntarily recalling specific lots of frozen yellow onion strips due to potential Listeria monocytogenes contamination.

    Product
    IQF 3/8" Yellow Onion Strip, Frozen, Item number 103331, bulk tote, net wt. 1150 lbs. IQF 3/8" Yellow Onion Strip, Frozen, item number 103368, bulk case, net wt. 40 lbs. Onion, Strips 3/8" 103369 40#, item number 103369, bulk case, net wt. 40 lbs. IQF 3/8" Yellow ORGANIC
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Food)·F-1926-2016·2016-08-24

    Sun Life Sunflower Spread Recalled for Listeria Contamination Risk

    Nu Life Market LLC is recalling Sun Life Enjoy Life Sunflower Spread because it may be contaminated with Listeria monocytogenes.

    Product
    Sun Life Enjoy Life Sunflower Spread, Net Wt.. 40 lbs (18.18 kg). The responsible name on the label is Nu Life Market, LLC, Scott City, KS.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2575-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 50,055 units distributed worldwide.

    Product
    Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1925-2016·2016-08-24

    Nu Life Sunflower Kernel Paste Recalled for Listeria Risk

    Nu Life Market LLC is recalling Sun Life Natural Sunflower Kernel Paste because it may be contaminated with Listeria monocytogenes.

    Product
    Sun Life Natural Sunflower Kernel Paste, Net Wt. 40 lbs (18.18 kg) buckets and 450 lbs. (204.12 kg) barrels. The responsible name on the label is Nu Life Market, LLC, Scott City, KS.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1938-2016·2016-08-24

    Oregon Potato Company Recalls Frozen Yellow Onion Dice for Listeria Risk

    Oregon Potato Company is voluntarily recalling specific lots of frozen yellow onion dice due to potential Listeria monocytogenes contamination.

    Product
    IQF 1/4" Yellow Onion Dice, frozen, item numbers: 103364, 103381, and 104831, bulk cases, net wt. 45 lbs.; 11244CH Onion Dice 1/4, frozen, item number 103381, bulk cases, net wt. 45 lbs. Onion, Diced 1/4" IQF 45#CS, item number 104155, bulk cases, net wt. 45 lbs.
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Food)·F-1942-2016·2016-08-24

    Oregon Potato Company Recalls Frozen White Onion Dice for Listeria Risk

    Oregon Potato Company is voluntarily recalling IQF 1/4" Frozen White Onion Dice due to potential Listeria monocytogenes contamination.

    Product
    IQF 1/4" Frozen WHITE Onion Dice, item number 103342, bulk cases, net wt. 45 lbs.
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Food)·F-1946-2016·2016-08-24

    Oregon Potato Company Recalls Frozen Yellow Onion Dice for Listeria Risk

    Oregon Potato Company is voluntarily recalling 3/8" Frozen Yellow Onion Dice due to potential Listeria monocytogenes contamination. The product was distributed in 17 US states, Canada, and Ireland.

    Product
    705000 IQF 3/8" Dice Yellow Onion, item number 101472, bulk tote, net wt. 1250 lbs. IQF 3/8" Yellow Onion Dice, item number 103330, 103341, bulk cases, net wt. 20 lbs. IQF 3/8" Yellow Onion Dice, item numbers 101578, 104147, and 104193, bulk cases, net wt. 45 lbs. IQF 3/
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Drugs)·D-1458-2016·2016-08-24

    Golden State Medical Supply Recalls Venlafaxine Hydrochloride Extended-Release Capsules

    Golden State Medical Supply Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, due to failed dissolution specifications.

    Product
    Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1944-2016·2016-08-24

    Oregon Potato Company Recalls Fresh White Onion Strips for Listeria Risk

    Oregon Potato Company is voluntarily recalling fresh white onion strips due to potential Listeria monocytogenes contamination.

    Product
    3/8" White Onion Strip-FRESH, item number 105196, bulk totes, net wt. 1200 lbs.
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Devices)·Z-2567-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recalled for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Flat L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 119,770 units distributed worldwide.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1874-2016·2016-08-24

    Hydroblend Tortilla Crusted Crumb Recalled for E. coli O121 Contamination Risk

    Hydroblend Inc. is recalling Tortilla Crusted Crumb due to potential contamination with E. coli O121. The product was distributed in Washington state.

    Product
    Tortilla Crusted Crumb is a breading system. Product Item Key N21997-B. It composed of flour and other food grade ingredients. Product is bagged in 25 lbs. multiwalled polylined paper bags.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1943-2016·2016-08-24

    Oregon Potato Company Recalls Fresh White Onion Dice for Listeria Risk

    Oregon Potato Company is voluntarily recalling fresh white onion dice due to potential Listeria monocytogenes contamination. The product was distributed across multiple US states, Canada, and Ireland.

    Product
    3/8" White Onion Dice- FRESH, item number 105197, bulk tote, net wt. 1250 lbs.
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Food)·F-1922-2016·2016-08-24

    Newly Weds Foods Recalls Flour Breader Contaminated with E. coli O121

    Newly Weds Foods Inc is recalling bulk flour bland breader contaminated with E. coli O121. The product was distributed nationwide in 15, 30, and 50 lb bags or boxes.

    Product
    Bulk flour bland breader packaged into 15, 30, and 50 lb bags or boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2526-2016·2016-08-24

    Ab Sciex API 3200MD Software Recall for Incorrect Quantitative Results

    Ab Sciex is recalling MultiQuant MD software for API 3200MD systems due to potential incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compoun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2584-2016·2016-08-24

    Synthes Titanium Single Vector Distractor Body Recalled for Fastener Separation

    Synthes (USA) Products LLC is voluntarily recalling Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2551-2016·2016-08-24

    Merge Unity Z3D Software Recalled for Calcium Score Inaccuracy

    Merge Healthcare is recalling Merge Unity Z3D software because it cannot accurately determine calcium scores for scans with slice thicknesses other than 3 mm.

    Product
    Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging sys
    Category
    Medical Device
    Distribution
    4 states
  • HighNHTSA·16V615000·2016-08-24

    Hyundai Recalls 2016 Sonata Vehicles Due to Driver Air Bag Defect

    Hyundai is recalling specific 2016 Sonata vehicles because the driver-side frontal air bag may not adequately protect the driver's neck in a crash.

    Product
    HYUNDAI — HYUNDAI SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers units distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a sin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i is recalling 1,648,273 dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2016·2016-08-24

    Nidek Optical Biometer AL-Scan Recalled for Inaccurate Axial Length Measurements

    Nidek Inc. is recalling 17 Optical Biometer AL-Scan devices because they measured axial lengths as much shorter than actual values.

    Product
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature rad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2016·2016-08-24

    OraSure Recalls OraQuick Ebola Rapid Antigen Test Due to Stability Failures

    OraSure Technologies is recalling 3,075 units of the OraQuick Ebola Rapid Antigen Test because stability testing revealed intermittent false negative results.

    Product
    OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1916-2016·2016-08-24

    Kerry Inc. Recalls Jalapeño Breader Due to E. coli O121 Contamination Risk

    Kerry Inc. is recalling Golden Dipt Jalapeño Breader because it was made with flour potentially contaminated with E. coli O121.

    Product
    Golden Dipt¿ Jalape¿o Breader is in a white 10 pound bag with the UPC number 763089721548 and Item Number: G5620.690.
    Category
    Food
    Distribution
    9 states

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