The Recall Desk

Archive

December 2016 recalls

806 recalls were announced in December 2016.

What the numbers show

Critical
107
Severe
205
High
274
Moderate
178
Low
42

Of the 806 recalls this month scored against our rubric, 13% are Critical, 25% are Severe.

Which agencies issued them

401–500 of 806

  • HighFDA (Devices)·Z-0746-2017·2016-12-21

    Steris Recalls Harmony Insight Diagnostic Monitor Support Systems

    Steris Corporation is recalling 63 Harmony Insight Diagnostic Monitor Support Systems because spring arm screws may not be properly secured and could become loose.

    Product
    Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0724-2017·2016-12-21

    JFC International Recalls Ramune Candy for Undeclared Wheat Allergen

    JFC International is recalling You-ka Fresh Ramune candy because it may contain undeclared wheat. Consumers with wheat allergies should not consume the product.

    Product
    You-ka Fresh Ramune Net Wt. 3.87oz (110g), Item No. 23925, 20 packs/case
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0737-2017·2016-12-21

    Publix Danish Guava Coffee Cake Recalled for Metal Shavings

    Publix Super Markets is recalling Danish Guava Coffee Cake Strips due to the presence of small metal shavings.

    Product
    Publix Danish Guava Coffee Cake Strip, 15 oz. UPC 002-19562-00000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0704-2017·2016-12-21

    Cinnabar Specialty Foods Recalls Neera's Spicy Thai Sauce for Undeclared Wheat

    Cinnabar Specialty Foods, Inc. is recalling Neera's Spicy Thai Sauce and Marinade because the product contains undeclared wheat.

    Product
    Neeras Spicy Thai Sauce and Marinade, Net Volume 150ml/5 fl. oz.., 12 units/case, or 6 units/partial case, 2.0 gallon pail.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0736-2017·2016-12-21

    Publix Danish Almond Coffee Cake Recalled for Metal Shavings

    Publix Super Markets is recalling Danish Almond Coffee Cake strips due to the presence of small metal shavings.

    Product
    Publix Danish Almond Coffee Cake Strip, 15 oz. UPC 002-19562-00000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0765-2017·2016-12-21

    Stryker Recalls Reprocessed Xcel Bladeless Trocars Due to Plug Breakage

    Stryker is recalling 40,476 reprocessed Xcel Bladeless Trocars because the adjustable plug may break in packaging or during use.

    Product
    Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2017·2016-12-21

    Integra York Metzenbaum Scissors Recalled Due to Packaging Seal Separation

    Integra York PA, Inc. is recalling 50 units of sterile Metzenbaum Scissors because packaging seals may separate, compromising sterility.

    Product
    Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0734-2017·2016-12-21

    Publix Danish Raspberry Coffee Cake Recalled for Metal Shavings

    Publix Super Markets is recalling Danish Raspberry Coffee Cake strips due to the presence of small metal shavings. The product was distributed in six southeastern states.

    Product
    Publix Danish Raspberry Coffee Cake Strip, 15 oz. UPC 002-19562-00000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0751-2017·2016-12-21

    Integra York Recalls Sterile Rochester-Pean Hemostatic Forceps Due to Seal Defect

    Integra York PA, Inc. is recalling 150 units of sterile Rochester-Pean Hemostatic Forceps because packaging seals may separate, compromising sterility.

    Product
    Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·16V918000·2016-12-21

    Volvo Recalls 2017 S60, V60, and XC60 for Side Air Bag Defect

    Volvo is recalling 2017 S60, V60, and XC60 vehicles because side air bag inflator initiators may fail to ignite during a crash, preventing deployment.

    Product
    VOLVO — VOLVO V60, XC60, S60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0718-2017·2016-12-21

    Clear Spring Foods Recalls Sun-Dried Tomato and Roasted Garlic Trout Fillets

    Clear Spring Foods is recalling Sun-Dried Tomato & Roasted Garlic Trout Fillets due to potential E. coli contamination. The product was distributed in five US states.

    Product
    Label reads in part "***SUN-DRIED TOMATO & ROASTED GARLIC TROUT FILLETS *** Product of USA *** CONTAINS: FISH (TROUT), WHEAT, MILK. *** UPC 10 070765 08761 2 Individual retail packages are mostly green with information panel in white with black lettering. Cases are 10 lbs…
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·16V920000·2016-12-21

    Toyota Recalls 2017 86 Vehicles for Ignition Key Removal Defect

    Toyota is recalling 2017 86 vehicles with automatic transmissions and ignition keys because the key may be removed without the transmission in Park, increasing the risk of the vehicle rolling away.

    Product
    TOYOTA — TOYOTA 86
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0717-2017·2016-12-21

    H-E-B Recalls Baby Pear Peas Zucchini Cups Due to Foreign Object

    H-E-B is recalling specific lots of Baby Pear Peas Zucchini cups because a customer reported finding a small piece of rubber inside the product.

    Product
    HEB Baby Pear Peas Zucchini 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0682-2017·2016-12-21

    Good Sense Trail Mix Recalled for Undeclared Allergens

    Waymouth Farms is recalling Good Sense Trail Mix, Cranberries 'N More, because it may contain undeclared pecans, walnuts, wheat, milk, and soy.

    Product
    Good Sense Trail Mix, Cranberries 'N More, Net Wt. 6 oz. (170g). Cranberries, Sunflower Nuts, Cashews, Pumpkin Seeds, Almonds, Apples. UPC 30243-86343.
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-0761-2017·2016-12-21

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators for Unexpected Power Loss

    Physio-Control is recalling 1,399 LIFEPAK 15 monitor/defibrillators because they may power down unexpectedly during use.

    Product
    The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0759-2017·2016-12-21

    Telefac Medical Recalls Weck Facial Closure Systems Due to Detachment Risk

    Teleflex Medical is recalling 2,265 units of Weck Facial Closure Systems because the device wings may partially detach from the shield during use.

    Product
    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2017·2016-12-21

    Teleflex Visistat Skin Staplers Recalled for Sterility Deficiency

    Teleflex Medical is recalling Visistat 35W disposable skin staplers because improper packaging seals mean sterility is not assured.

    Product
    WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0725-2017·2016-12-21

    JFC International Recalls Fizzy Candy Punch Ramune for Undeclared Wheat

    JFC International is recalling Fizzy Candy Punch Ramune because it may contain undeclared wheat allergen. The recall affects 500 packs distributed in five states.

    Product
    You-ka Punch Ramune Net Wt. 3.87oz (110g), Item No. 23926, 20 packs/case
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0728-2017·2016-12-21

    Prism Medical Carry Bar Recall Due to Breaking Plastic Component

    Prism Medical is recalling carry bars for patient lifts because a black plastic puck may break, posing a risk of harm to patients.

    Product
    Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0735-2017·2016-12-21

    Publix Danish Cherry Coffee Cake Recalled for Metal Shavings

    Publix Super Markets is recalling Danish Cherry Coffee Cake strips due to the presence of small metal shavings. The product was distributed in six southeastern states.

    Product
    Publix Danish Cherry Coffee Cake Strip, 15 oz. UPC 002-19562-00000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0732-2017·2016-12-21

    Publix Danish Apple Coffee Cake Recalled for Metal Shavings

    Publix Super Markets is recalling Danish Apple Coffee Cake strips due to the presence of small metal shavings. The product was distributed in six southeastern states.

    Product
    Publix Danish Apple Coffee Cake Strip, 15 oz. UPC 002-19562-00000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0766-2017·2016-12-21

    Encore Medical Recalls Empowr PS Knee System Box Cut Guides

    Encore Medical is recalling 162 Empowr PS Knee System Box Cut Guides because femoral chipping occurred during surgery.

    Product
    Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2017·2016-12-21

    Elekta Recalls MOSAIQ Oncology Information System Due to Data Saving Error

    Elekta is recalling 47 MOSAIQ Oncology Information System units because edits to particle field definition parameters may not be saved.

    Product
    MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0681-2017·2016-12-21

    Giant Eagle Recalls Buffalo Hot Peanuts Due to Undeclared Cashews and Wheat

    Giant Eagle is recalling 248 units of Farmers Market Buffalo Hot Peanuts because they contain undeclared cashews and wheat. The error was caused by mislabeling at the manufacturer.

    Product
    Clear plastic cup labeled as: The Farmers Market Buffalo Hot Peanuts; Net Wt. 5 oz.; UPC 3003499846; Best By 10/25/2016
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0767-2017·2016-12-21

    Firefly Medical Recalls IVEA 500A Medical Beds Due to Dowel Pin Defect

    Firefly Medical is recalling 239 IVEA 500A medical beds because a dowel pin could slip out, causing the bed to slump and potentially making a patient stumble.

    Product
    IVEA 500A Intended for Med-Surg patient care.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0733-2017·2016-12-21

    Cook Medical Recalls Central Venous Catheter Trays Due to Incorrect Needles

    Cook Medical is recalling 99 units of Spectrum Minocycline/Rifampin Impregnated Central Venous Catheter Trays because they may contain incorrect needles, potentially preventing wire guide passage.

    Product
    Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0729-2017·2016-12-21

    Merge Cardio software recalled for potential report matching errors

    Merge Healthcare is recalling Merge Cardio software versions 8.30.0 through 10.1.1 because images sent without an order may be matched to the wrong accession number.

    Product
    Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0743-2017·2016-12-21

    Cargill Recalls Crisco Professional Liquid Butter Alternative for Excessive Additives

    Cargill is recalling Crisco Professional Liquid Butter Alternative because it contains excessive amounts of TBHQ and DMPS. The product was distributed to 29 states.

    Product
    Crisco PROFESSIONAL Liquid Butter Alternative, SALTED FOR ADDED FLAVOR, NET/NETO 1 GAL (3.79 L) INGREDIENTS; Corn Oil, Soybean Oil, Sunflower Oil, Hydrogenated Soybean Oil, Salt, Soy Lecithin***TBHQ ***Dimethylpolysiloxane***CONTAINS: SOY. UPC 7 81525 64775 7
    Category
    Food
    Distribution
    29 states
  • HighFDA (Devices)·Z-0755-2017·2016-12-21

    GE Healthcare Recalls Avance and Amingo Anesthesia Devices Due to Malfunction Risk

    GE Healthcare is recalling specific Avance CS2, Avance, and Amingo anesthesia devices because they may enter a System Malfunction state if a storage drawer closes with excessive force.

    Product
    GE Healthcare, Avance, Avance CS2, Amingo.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2017·2016-12-21

    GF Health Products Recalls Patriot Homecare Beds Due to Motor Defect

    GF Health Products is voluntarily correcting Patriot homecare beds because contaminated motor housings may crack, potentially causing the head section to fall.

    Product
    Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2017·2016-12-21

    Accuray Recalls CyberKnife Systems Due to Unexpected Robot Motion

    Accuray is recalling 40 CyberKnife Robotic Radiosurgery Systems with software version 10.6 due to a potential safety issue involving unexpected treatment robot motion when removing an accessory.

    Product
    CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy…
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0770-2017·2016-12-21

    Natus neoBLUE blanket LED Phototherapy System Recalled for Fiber Optic Degradation

    Natus Medical is recalling neoBLUE blanket LED Phototherapy Systems due to discoloration and degradation of the fiberoptic bundle at the pad and box connection.

    Product
    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0748-2017·2016-12-21

    Ellman Minor Surgery Bipolar Cable Recalled for Mismatched Expiration Dates

    Ellman International is recalling 370 boxes of Minor Surgery Bipolar Cables because the expiration dates on the outer boxes and individual pouches do not match.

    Product
    ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar…
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-0715-2017·2016-12-21

    H-E-B Recalls Baby Banana Carrot Mango Cups Due to Rubber Piece

    H-E-B is recalling specific lots of Baby Banana Carrot Mango cups after a customer reported finding a small piece of rubber inside the product.

    Product
    HEB Baby Banana Carrot Mango 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0768-2017·2016-12-21

    Beckman Coulter Recalls MicroScan LabPro Data Management System Software

    Beckman Coulter is recalling MicroScan LabPro Data Management System version 4.42 due to intermittent behavior that may delay reporting results.

    Product
    MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0730-2017·2016-12-21

    Merge Cardio software recall for data loss during inactivity

    Merge Healthcare is recalling Merge Cardio software versions 10.1 and 10.1.1 because the reporting feature times out after one hour of inactivity, causing data loss.

    Product
    Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0683-2017·2016-12-21

    Galliker's Lemon Iced Tea Recalled for Missing Pasteurization Documentation

    Galliker Dairy Co. is recalling 2,851 gallon jugs of lemon iced tea because the products were labeled as pasteurized without legal documentation to support the claim.

    Product
    Galliker's Lemon Iced Tea Flavored, 1 GAL and Galliker's Lemon Flavored Iced Tea, 1/2 GAL
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0758-2017·2016-12-21

    Halyard Health Recalls Sterling Nitrile Sterile Exam Gloves Due to Defects

    Halyard Health is recalling Sterling Nitrile Sterile Powder Free Exam Gloves because they may be discolored and brittle, causing them to tear when put on.

    Product
    Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Food)·F-0744-2017·2016-12-21

    Cargill Recalls Butter Flavored Oil Due to Excessive Additives

    Cargill is recalling 1-gallon bottles of refyne Butter Flavored Oil because they contain excessive amounts of TBHQ and dimethyl polysiloxane.

    Product
    refyne Artificially Flavored BUTTER FLAVORED OIL, NET CONTENTS 1 GAL (3.79 L) INGREDIENTS; SOYBEAN OIL, HYDROGENATED SOYBEAN OIL,***TBHQ--- Dimethylpolysiloxane***CONTAINS: SOY., UPC 0 41560 13659 4
    Category
    Food
    Distribution
    29 states
  • ModerateFDA (Food)·F-0712-2017·2016-12-21

    H-E-B Recalls Baby Pear Carrot Blueberry Cups Due to Foreign Object

    H-E-B is recalling specific lots of Baby Pear Carrot Blueberry cups after a customer reported finding a small piece of rubber inside the product.

    Product
    HEB Baby Pear Carrot Blueberry 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0743-2017·2016-12-21

    Siemens SOMATOM Definition Flash CT Systems Recalled for Software Update

    Siemens is recalling 104 SOMATOM Definition Flash CT systems to install a software and firmware update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0735-2017·2016-12-21

    C.R. Bard Recalls 70cc Irrigation Syringes Due to Package Defect

    C.R. Bard is recalling 452,728 units of 70cc irrigation syringes because a package defect may compromise product sterility.

    Product
    BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0722-2017·2016-12-21

    Wegmans Milk Chocolate Covered Pretzels Recalled for Incorrect Labeling

    First Source, LLC is recalling Wegmans Milk Chocolate Covered Pretzels because the rear label is incorrect and lacks allergen declarations.

    Product
    Wegmans Milk Chocolate Covered Pretzels, NET WT 9.5 OZ (269g)
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0762-2017·2016-12-21

    Randox Liquid Cardiac Controls Recalled for Decreased Analyte Recovery

    Randox Laboratories is recalling Randox Liquid Cardiac Controls Level 1, 2, and 3 because internal stability monitoring revealed decreased recovery of myoglobin and CKMB.

    Product
    The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateUSDA FSIS·119-2016·2016-12-21

    Ruiz Recalls Beef and Cheese Tortillas Due to Plastic Contamination

    Ruiz Food Products is recalling beef and cheese tortillas that may contain brittle clear plastic. No injuries have been reported.

    Product
    Ruiz Food Products, Inc. — Ruiz Food Products, Inc. Recalls Beef and Cheese Tortilla Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0747-2017·2016-12-21

    PerkinElmer RoboRack Filter Tips Recalled for Inaccurate Liquid Handling

    PerkinElmer is recalling 595 trays of RoboRack filter tips because they may not seal properly, causing inaccurate liquid aspiration and dispensing in automated workstations.

    Product
    Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Automated Workstations: Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0763-2017·2016-12-21

    Oculus Recalls Ceramax Skin Barrier Cream Professional Samples

    Oculus Innovative Sciences is recalling professional samples of Ceramax Skin Barrier Cream because they are not meeting stability standards.

    Product
    Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0714-2017·2016-12-21

    H-E-B Recalls Baby Green Beans Due to Foreign Material

    H-E-B is recalling 855 units of Baby Green Beans cups sold in Texas after a customer reported finding a small piece of rubber inside the product.

    Product
    HEB Baby Green Beans 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0741-2017·2016-12-21

    Cargill Recalls Monarch Liquid Butter Alternative Due to Excessive Additives

    Cargill is recalling Monarch Liquid Butter Alternative because it contains excessive amounts of TBHQ and dimethyl polysiloxane.

    Product
    MONARCH LIQUID BUTTER ALTERNATIVE, ARTIFICIALLY FLAVORED ,NET/NETO 1 GAL (3.79 L) INGREDIENTS; SOYBEAN OIL, HYDROGENATED SOYBEAN OIL WITH SALT***TBHQ***DIMETHYLPOLYSILOXANE***CONTAINS: SOY. UPC 7 58108 38874 1
    Category
    Food
    Distribution
    29 states
  • ModerateFDA (Food)·F-0719-2017·2016-12-21

    Clif Bar Recalls Chocolate Hazelnut Butter Energy Bars Due to Foreign Material

    Clif Bar & Company is recalling specific production runs of Chocolate Hazelnut Butter Energy Bars after receiving complaints of foreign material in the product.

    Product
    Chocolate Hazelnut Butter CLIF¿ Nut Butter Filled Energy Bars; NET WT: 1.76 oz (50 g). Packages in boxes of 12 individual bars. UPC - bar: 7 22252 26800 6; UPC - 12 count box: 7-22252-36800-3; UPC-case: 00722252-56800-7 Distributed by Clif Bar & Company, Emeryville, CA…
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0736-2017·2016-12-21

    C.R. Bard Recalls 70cc Piston Syringes Due to Package Defect

    C.R. Bard is recalling 70cc Piston Syringes because a package slit defect may compromise product sterility.

    Product
    BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0754-2017·2016-12-21

    Olympus HF Cable WA00014A Recalled for Software Malfunction

    Olympus Corporation of the Americas is recalling 494 HF Cable WA00014A units due to a software malfunction that may cause incorrect error codes to be generated or displayed.

    Product
    HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0756-2017·2016-12-21

    Recall of Sterile Specimen Containers Due to Packaging Defect

    Covidien LLC is recalling 5,187,100 sterile specimen containers because a packaging defect compromised the sterility of the outer surface.

    Product
    Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0716-2017·2016-12-21

    H-E-B Baby Squash Sweet Corn Tomato Cups Recalled for Rubber Piece

    H-E-B is recalling Baby Squash Sweet Corn Tomato 4-ounce cups due to a customer report of a rubber piece inside the product.

    Product
    HEB Baby Squash Sweet Corn Tomato 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0737-2017·2016-12-21

    C.R. Bard Recalls Piston Syringes Due to Package Defect Risk

    C.R. Bard is recalling specific lots of 60cc Piston Syringes because a package slit defect may compromise product sterility.

    Product
    BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0742-2017·2016-12-21

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions USA is recalling 104 SOMATOM Definition AS CT systems to install software and firmware updates that fix bugs and improve performance.

    Product
    SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0741-2017·2016-12-21

    Cypress Medical Recalls McKesson Vinyl Exam Gloves for Leak Test Failure

    Cypress Medical Products is recalling McKesson Powder Free Vinyl Exam Gloves because a container failed the FDA leak test. The recall is limited to one distribution center in Auburn, Washington.

    Product
    McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0744-2017·2016-12-21

    Siemens SOMATOM Definition Edge CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions is recalling 104 SOMATOM Definition Edge CT systems to install a software update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0749-2017·2016-12-21

    Ulthera Recalls Cellfina Prep Packs Due to Non-Sterile Vacuum Tube

    Ulthera Inc is recalling Cellfina Prep Packs because they contain a non-sterile vacuum tube, while the instructions describe using a sterile tube.

    Product
    Cellfina Prep Pack, Part No. CP1
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0738-2017·2016-12-21

    C.R. Bard Recalls BARDIA 60cc Piston Irrigation Syringes Due to Package Defect

    C.R. Bard is recalling BARDIA 60cc Piston Irrigation Syringes because a slit defect in the packaging may compromise product sterility.

    Product
    BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0740-2017·2016-12-21

    BD Recalls Spinal Anesthesia Trays Due to Incorrect Labeling

    Becton Dickinson is recalling 4,500 BD Spinal Anesthesia Trays because a small number were incorrectly labeled as Epidural Trays.

    Product
    BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0769-2017·2016-12-21

    Natus neoBLUE Phototherapy Systems Recalled for Fiberoptic Pad Failure

    Natus Medical is recalling neoBLUE blanket LED Phototherapy Systems due to early failure of fiberoptic pads, which can cause discoloration and melting at the connector.

    Product
    Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0740-2017·2016-12-21

    Cargill Recalls Quali Fry Premium Buttery Pan and Grill Oil

    Cargill is recalling Quali Fry Premium Buttery Pan and Grill Oil because it contains excessive amounts of TBHQ and dimethyl polysiloxane.

    Product
    QUALI FRY PREMIUM BUTTERY PAN AND GRILL, ARTIFICIALLY FLAVORED OIL, NET/NETO 1 GAL (3.79 L) INGREDIENTS: SOYBEAN OIL, HYDROGENATED SOYBEAN OIL***TBHQ***DIMETHYLPOLYSILOXANE***CONTAINS: SOY, UPC 7 58108 45416 3
    Category
    Food
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0757-2017·2016-12-21

    Pentax Ultrasound Video Bronchoscope Recalled for Incorrect Instructions

    Pentax of America Inc. is recalling 113 Ultrasound Video Bronchoscopes because they shipped with outdated instructions for use.

    Product
    Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0750-2017·2016-12-21

    Roche Recalls LightMix Zika rRT-PCR Test Due to False Positive Risk

    Roche Molecular Systems is recalling the LightMix Zika rRT-PCR Test because the software algorithm may occasionally report false positive results.

    Product
    LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0713-2017·2016-12-21

    H-E-B Recalls Baby Sweet Potato Cups Due to Foreign Object

    H-E-B is recalling Baby Sweet Potato cups after a customer reported finding a small piece of rubber inside the product.

    Product
    HEB Baby Sweet Potato 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0205-2017·2016-12-21

    Jubilant Cadista Recalls Methylprednisolone Tablets Due to Incorrect Expiration Date Labeling

    Jubilant Cadista Pharmaceuticals is recalling 1,512 bottles of Methylprednisolone Tablets, USP, 16 mg, because the expiration date is printed incorrectly as 02/0218 instead of 02/2018.

    Product
    Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V913000·2016-12-20

    Volkswagen Recalls 2009-2010 Models for ABS Control Unit Failure

    Volkswagen is recalling 2009-2010 Jetta, GTI, Golf, and Audi A3 vehicles because the ABS control unit may fail, potentially causing loss of vehicle control.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI JETTA SPORTWAGEN, JETTA, GTI, GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·17056·2016-12-20

    Zebra Thermal Printer Power Supply Units Recalled for Fire Hazard

    Zebra Technologies is recalling approximately 166,000 power supply units for thermal printers due to a fire hazard caused by overheating and corrosion.

    Product
    Power supply units for Zebra brand thermal printers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V912000·2016-12-20

    C&M Recalls 2016 Trailers with Missing Front Reflex Reflectors

    C&M Trailers is recalling 670 model year 2016 boat, jet ski, and utility trailers because they may be missing front reflex reflectors, which could make them harder to see.

    Product
    C&M — C&M BOAT TRAILER, JET SKI TRAILER, UTILITY TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V914000·2016-12-20

    BMW, MINI, and Rolls-Royce Recall for Air Bag Initiator Defect

    BMW is recalling 2016-2017 vehicles because seat-mounted air bag initiators may fail to ignite, preventing deployment and increasing injury risk.

    Product
    BMW — BMW, MINI, ROLLS-ROYCE X1 SAV, 550I, M5, 535D
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16C008000·2016-12-19

    Baby Trend Recalls Booster Seats Due to Harness Rivet Failure Risk

    Baby Trend is recalling specific Hybrid LX booster seats because a center adjuster rivet may break if used with children over 40 lbs, increasing injury risk in a crash.

    Product
    CHILD SEAT:HARNESS:STRAP/WEBBING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V911000·2016-12-19

    Nissan Recalls Altima, Rogue, and Maxima for Air Bag Sensor Defect

    Nissan is recalling specific 2013-2016 Altima, Rogue, and Maxima vehicles because an incorrect air bag sensor may misclassify front passengers, increasing injury risk in crashes.

    Product
    NISSAN — NISSAN ALTIMA, ROGUE, MAXIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·17055·2016-12-16

    LG Recalls Portable Air Conditioners Due to Fire Hazard

    LG Electronics is recalling about 466,000 portable air conditioners sold in the U.S. because they can overheat and cause fires.

    Product
    Portable Air Conditioners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V906000·2016-12-16

    Toyota Recalls 2016 Avalon and 2017 Camry for Knee Air Bag Fastener Issue

    Toyota is recalling specific 2016 Avalon and 2017 Camry vehicles because the front passenger knee air bag may be attached with incorrect fasteners, which could affect deployment and increase injury risk.

    Product
    TOYOTA — TOYOTA AVALON, CAMRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V910000·2016-12-16

    RAM ProMaster Recall: Side Air Bag Inflator May Fail to Ignite

    Chrysler is recalling 2017 RAM ProMaster vehicles because the seat-mounted side air bag inflator initiator may fail to ignite during a crash.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V909000·2016-12-16

    C&M Utility Trailer Recall for Missing Tire Placard Information

    C&M is recalling 2015-2016 Utility trailers because the tire placard may lack required size information, which could lead to incorrect tire replacements.

    Product
    C&M — C&M UTILITY TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V907000·2016-12-16

    Chrysler Recalls 2016 Jeep and Dodge Vehicles for Engine Stalling Risk

    Chrysler is recalling 42,231 model year 2016 Jeep Compass, Jeep Patriot, and Dodge Journey vehicles because an intermittent sensor may cause the engine to stall, increasing crash risk.

    Product
    JEEP — JEEP, DODGE PATRIOT, COMPASS, JOURNEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V908000·2016-12-16

    Keystone Recalls Fifth Wheel Trailers Due to Rear Door Hinge Welds

    Keystone is recalling 2016-2017 fifth wheel trailers because rear cargo door hinge welds may be insufficient, causing the door to swing down with excessive force.

    Product
    KEYSTONE — KEYSTONE, DUTCHMEN RAPTOR, FUZION, VOLTAGE, CARBON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·118-2016·2016-12-15

    R&R Provision Recalls Breaded Veal Products Due to Undeclared Allergens

    R&R Provision Company is recalling approximately 23,040 pounds of breaded veal products because they contain undeclared whey and nonfat milk.

    Product
    Schiff's Food Service, Inc., DBA R&R Provision Company — R&R Provision Company Inc. Recalls Breaded Veal Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • HighCPSC·17720·2016-12-15

    Figi's Recalls Christmas Wishes Tins Due to Choking and Battery Hazards

    Figi's Companies is recalling Christmas Wishes tins because the sound chip mechanism can separate, exposing button batteries that pose choking and ingestion hazards to children.

    Product
    Christmas Wishes tins
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V905000·2016-12-15

    Jayco Recalls 2016 Alante and Precept Motorhomes for Step Wiring Defect

    Jayco is recalling 2016 Alante and Precept motorhomes because incorrectly installed entrance step wiring may cause the steps to retract unexpectedly, posing a fall risk.

    Product
    JAYCO — JAYCO ALANTE, PRECEPT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V904000·2016-12-15

    AEV Traumahawk Ambulances Recalled for Cot Mount Attachment Defect

    Halcore Group is recalling 2016 AEV Traumahawk ambulances because Stryker Medical Performance cot mounts may not securely attach the cot, posing a risk of serious injury.

    Product
    AEV — AEV TRAUMAHAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E094000·2016-12-15

    Autoliv Recalls Seatbelt Pretensioners Due to Detachment Risk

    Autoliv is recalling specific seatbelt retractors because a subcomponent may detach after deployment, creating a projectile hazard inside the vehicle.

    Product
    SEAT BELTS:PRETENSIONER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V903000·2016-12-15

    Mercedes-Benz Recalls SUVs for Front Passenger Air Bag Defect

    Mercedes-Benz is recalling specific 2016-2017 SUVs because the front passenger air bag may not deploy due to a calibration error.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GL350, GL550, AMG GLE43, GLE350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0589-2017·2016-12-14

    Club Chef Broccoli and Raisin Salad Kits Recalled for Listeria Risk

    Club Chef LLC is recalling Broccoli & Raisin Salad Kits because the supplier reported potential Listeria monocytogenes contamination.

    Product
    Club Chef Broccoli & Raisin Salad Kits, in 7.625 lb cases, containing 1bag (4.8 oz) of Raisin Sunflower Mix per case.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0601-2017·2016-12-14

    Agave Dream Lavender Recalled for Potential Listeria Contamination

    Agave Dream is recalling 1 Pint Lavender products due to potential Listeria monocytogenes contamination. The product was distributed in eight U.S. states.

    Product
    Agave Dream Lavender 1 Pint UPC Code 8 9934900206 2
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0643-2017·2016-12-14

    E S Foods Recalls Tuna Salad Meal Breaks Due to Listeria Risk

    E S Foods is recalling Tuna Salad w/Milk Meal Breaks because a supplier verified potential Listeria monocytogenes contamination in the raw material.

    Product
    Tuna Salad w/Milk Meal Break, Item #61603
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-0626-2017·2016-12-14

    GNC Women's Ultra Mega Recalled for Undeclared Milk Allergen

    Nutra Manufacturing is recalling GNC Women's Ultra Mega dietary supplements because they contain undeclared milk, a major food allergen.

    Product
    GNC, Womens Ultra Mega, Dietary Supplement, 180 Caplets,
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0566-2017·2016-12-14

    McConnell's Ice Cream Recalled for Potential Listeria Contamination

    McConnell's Ice Cream, Inc. is recalling Salted Caramel Chip ice cream due to potential Listeria monocytogenes contamination. The product was distributed in 12 U.S. states.

    Product
    McConnell's Fine Ice Cream Salted Caramel Chip
    Category
    Food
    Distribution
    13 states

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