The Recall Desk

Archive

October 2016 recalls

1,035 recalls were announced in October 2016.

What the numbers show

Critical
136
Severe
242
High
453
Moderate
173
Low
31

Of the 1,035 recalls this month scored against our rubric, 13% are Critical, 23% are Severe.

801–900 of 1035

  • HighFDA (Food)·F-2533-2016·2016-10-12

    Rabbit Creek Red Zinfandel Wine Brownie Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Red Zinfandel Wine Brownie Mix because the flour used may have been contaminated with E. coli O121.

    Product
    Red Zinfandel Wine Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 12.25oz, UPC 010749040205
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2557-2016·2016-10-12

    Rabbit Creek Italian Parmesan Beer Bread Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Italian Parmesan Beer Bread Mix because it may contain flour contaminated with E. coli O121.

    Product
    Italian Parmesan Beer Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 16oz, UPC 010749008038
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0008-2017·2016-10-12

    Microgenics Recalls QMS Everolimus Assay Due to Reagent Stability Issue

    Microgenics Corporation is recalling the Thermo Scientific QMS Everolimus Assay because a reagent stability issue causes inaccurate test results for transplant patients.

    Product
    Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0007-2017·2016-10-12

    Baxter Recalls 0.2 Micron Filters Due to Missing Membrane

    Baxter Corporation is voluntarily recalling 0.2 Micron Filters because the filter membrane may be missing, allowing particulate matter to pass through.

    Product
    0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2486-2016·2016-10-12

    Rabbit Creek Apple Streusel Muffin Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products Inc. is recalling Apple Streusel Muffin Mix because the flour used may have been contaminated with E. coli O121.

    Product
    Apple Streusel Muffin Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15.9oz, UPC 010749011458
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2595-2016·2016-10-12

    Rabbit Creek Cinnamon Swirl Quick Bread Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Flower Pot Cinnamon Swirl Quick Bread Mix because the flour used may have been contaminated with E. coli O121.

    Product
    Flower Pot Cinnamon Swirl Quick Bread Mix, packaged in a plastic bag which is placed in clay pot, net wt. 16.5oz, UPC 010749850507
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2587-2016·2016-10-12

    Rabbit Creek Bread Mix Recalled Due to E. coli O121 Contamination

    Rabbit Creek Products is recalling Rosemary & Garlic White Wine Bread Mix because it may contain flour contaminated with E. coli O121.

    Product
    Rosemary & Garlic White Wine Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15oz, UPC 010749040106
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2454-2016·2016-10-12

    Treehouse Foods Recalls Honey Roasted Sunflower Kernels for Listeria Risk

    Treehouse Foods is recalling Nature's Harvest Sunflower Kernels Honey Roasted due to potential contamination with Listeria monocytogenes.

    Product
    UPC 071715727510 Nature's Harvest Sunflower Kernels Honey Roasted., Best By/Date Code: 12/20/2016, 1/21/2017.
    Category
    Food
    Distribution
    38 states
  • HighFDA (Food)·F-2590-2016·2016-10-12

    Rabbit Creek Bread Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products is recalling Flower Pot Cheddar Bacon Beer Bread Mix because it may contain flour contaminated with E. coli O121.

    Product
    Flower Pot Cheddar Bacon Beer Bread Mix, packaged in a plastic bag which is placed in clay pot, net wt. 16.2oz, UPC 010749800182
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2507-2016·2016-10-12

    Rabbit Creek Flower Pot Muffin Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products Inc. is recalling Flower Pot Muffin Mix due to potential E. coli O121 contamination in the flour.

    Product
    Flower Pot Muffin Mix "Tangy" Lemon Poppyseed, packaged in a packaged in a plastic bag which is placed in a paper bag and packaged with two clay pots, net wt. 13.25oz, UPC 010749109131
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2573-2016·2016-10-12

    Rabbit Creek Cheesy Garlic Quick Bread Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Cheesy Garlic Quick Bread Mix because the flour used may have been contaminated with E. coli O121.

    Product
    Cheesy Garlic Quick Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15.5oz, UPC 010749008359
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2521-2016·2016-10-12

    Rabbit Creek Brownie Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products is recalling Drunken Cherry Wine Brownie Mix because it may contain flour contaminated with E. coli O121.

    Product
    Drunken Cherry Wine Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 11.5oz, UPC 010749040274
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2473-2016·2016-10-12

    Savory Foods Recalls Peanut Butter Cookies for Listeria Risk

    Savory Foods, Inc. is voluntarily recalling 1.5 oz peanut butter cookies due to potential Listeria monocytogenes contamination.

    Product
    1.5 oz PEANUT BUTTER COOKIES, 80/case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0008-2017·2016-10-12

    Yu Yee Black Pepper Powder Recalled for Salmonella Contamination

    Summit Import Corporation is recalling Yu Yee Brand Black Pepper Powder due to potential Salmonella contamination. The product was distributed in 12 states.

    Product
    Yu Yee Brand Black Pepper Powder, Net Wt. 19.4 oz (550g), UPC 0 23452 06084 2, Packed for Summit Import Corp., Jersey City, NJ 07305, Product of China
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-2575-2016·2016-10-12

    Rabbit Creek Cinnamon Pecan Quick Bread Mix Recalled for E. coli O121

    Rabbit Creek Products is recalling Cinnamon Pecan Quick Bread Mix because the flour used may be contaminated with E. coli O121.

    Product
    Cinnamon Pecan with Streusel Topping Quick Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 17.8oz, UPC 010749008717
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2512-2016·2016-10-12

    Rabbit Creek Cappuccino Brownie Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products Inc. is recalling Cappuccino Brownie Mix because it may contain flour contaminated with E. coli O121. Consumers should stop using the product.

    Product
    Cappuccino Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 10.8oz, UPC 010749011557
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2567-2016·2016-10-12

    Rabbit Creek Three Cheese Beer Bread Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Three Cheese Beer Bread Mix because the flour used may have been contaminated with E. coli O121.

    Product
    Three Cheese Beer Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 17.25oz, UPC 010749008274
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2589-2016·2016-10-12

    Rabbit Creek Bread Mix Recalled Due to E. coli O121 Contamination

    Rabbit Creek Products is recalling Tuscan Herb with Parmesan Cheese Wine Bread Mix because it may contain flour contaminated with E. coli O121.

    Product
    Tuscan Herb with Parmesan Cheese Wine Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 16oz, UPC 010749040045
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2599-2016·2016-10-12

    Rabbit Creek Bread Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products is recalling Flower Pot Sun Dried Tomatoes with White Wine Bread Mix because the flour used may be contaminated with E. coli O121.

    Product
    Flower Pot Sun Dried Tomatoes with White Wine Bread Mix, packaged in a plastic bag which is placed in clay pot, net wt. 15.5oz, UPC 010749045088
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2530-2016·2016-10-12

    Rabbit Creek Brownie Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products Inc. is recalling Raspberry with Cabernet Wine Brownie Mix because it may contain flour contaminated with E. coli O121.

    Product
    Raspberry with Cabernet Wine Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 10.8oz, UPC 010749040212
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2495-2016·2016-10-12

    Rabbit Creek Cranberry Orange Muffin Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Cranberry Orange Muffin Mix because the flour used may be contaminated with E. coli O121.

    Product
    Cranberry Orange Muffin Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 14.8oz, UPC 010749011304
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2585-2016·2016-10-12

    Rabbit Creek Bread Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products is recalling Cheese and Bacon Chardonnay Wine Bread Mix because it may contain flour contaminated with E. coli O121.

    Product
    Cheese and Bacon Chardonnay Wine Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 16.2oz, UPC 010749040052; Arbor Hill brand is labeled as Cheese and Bacon White Wine Bread Mix
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2525-2016·2016-10-12

    Rabbit Creek Brownie Mix Recalled Due to E. coli O121 Contamination

    Rabbit Creek Products Inc. is recalling Million Dollar Brownie Mix because it may contain flour contaminated with E. coli O121. Consumers should stop using the product.

    Product
    Million Dollar Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 12.7oz, UPC 010749011540
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2572-2016·2016-10-12

    Rabbit Creek Caramel Pecan Quick Bread Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Caramel Pecan with Streusel Topping Quick Bread Mix because it may contain flour contaminated with E. coli O121.

    Product
    Caramel Pecan with Streusel Topping Quick Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 18.25oz, UPC 010749008700
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2522-2016·2016-10-12

    Rabbit Creek Brownie Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products Inc. is recalling Intoxicated Nut Wine Brownie Mix because it may contain flour contaminated with E. coli O121.

    Product
    Intoxicated Nut Wine Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 11oz, UPC 010749040298
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2497-2016·2016-10-12

    Rabbit Creek Raspberry Streusel Muffin Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products Inc. is recalling Raspberry Streusel Muffin Mix because the flour used may have been contaminated with E. coli O121.

    Product
    Raspberry Streusel Muffin Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15.25oz, UPC 010749011397
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2531-2016·2016-10-12

    Rabbit Creek Brownie Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products is recalling Redneck Brownie Mix because it may contain flour contaminated with E. coli O121.

    Product
    Redneck (Potato Chip & Bacon) Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 12oz, UPC 010749111165
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2576-2016·2016-10-12

    Rabbit Creek Cinnamon Swirl Quick Bread Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Cinnamon Swirl Quick Bread Mix because it may contain flour contaminated with E. coli O121.

    Product
    Cinnamon Swirl Quick Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 16.5oz, UPC 010749008502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2545-2016·2016-10-12

    Rabbit Creek Blooming Onion Beer Bread Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Blooming Onion Beer Bread Mix because it may contain flour contaminated with E. coli O121.

    Product
    Blooming Onion Beer Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 16.8oz, UPC 010749007871
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2579-2016·2016-10-12

    Rabbit Creek Lemon Blueberry Quick Bread Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Lemon Blueberry Quick Bread Mix because it may contain flour contaminated with E. coli O121.

    Product
    Lemon Blueberry Quick Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 18.75oz, UPC 010749008601
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0013-2017·2016-10-12

    Siemens Recalls Multix Fusion X-Ray Systems Due to Table Tilt Risk

    Siemens is recalling 37 Multix Fusion X-ray systems because an internal table part may detach, causing the table to tilt and potentially injure patients.

    Product
    Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may be
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0042-2017·2016-10-12

    Trumpf Medical Systems Recalls Floor Mounting Columns for Unexpected Descent

    Trumpf Medical Systems is recalling 84 Floor Mounting Columns because they unexpectedly descended approximately 20 centimeters, posing a risk to patient safety during surgery.

    Product
    Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table
    Category
    Medical Device
    Distribution
    10 states
  • HighNHTSA·16V727000·2016-10-12

    Keystone Recalls 2017 Dutchmen Coleman Trailers for Wiring Fire Risk

    Keystone RV is recalling 84 model year 2017 Dutchmen Coleman recreational trailers because loose or frayed wiring in the power center may increase the risk of a fire.

    Product
    DUTCHMEN — DUTCHMEN COLEMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17010·2016-10-12

    Mamas & Papas Recalls Armadillo Strollers Due to Fall Hazard

    Mamas & Papas is recalling Armadillo Flip and Flip XT strollers because a loose latch can cause the seat to tip back, posing a fall hazard to infants.

    Product
    Mamas & Papas Armadillo Flip Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2543-2016·2016-10-12

    Rabbit Creek Basil Parmesan Beer Bread Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Basil Parmesan Beer Bread Mix because it may contain flour contaminated with E. coli O121.

    Product
    Basil Parmesan Beer Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15.25oz, UPC 010749008236
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16V730000·2016-10-12

    ShowHauler Garage Coach Lift Gate Chain Recall

    ShowHauler is recalling 2014-2015 Garage Coaches because lift gate roller chains may fail, causing the platform to drop and increasing injury risk.

    Product
    SHOWHAULER — SHOWHAULER GARAGE COACH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2639-2016·2016-10-12

    Martinelli Sparkling Cider Gift Baskets Recalled for Potential Glass Chips

    DesignPac Gifts is recalling Elegant Sophistication gift baskets containing Martinelli Sparkling Cider due to a risk of glass chips entering the beverage.

    Product
    Elegant sophistication gift basket containing apple cidar in glass bottles. The label on the back of the gift basket is white with black lettering.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2908-2016·2016-10-12

    Integra Drainage Accessory Kits Recalled Due to Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling specific lots of Integra Drainage Accessory Kits because a final inspection found an incomplete packaging seal, potentially compromising sterility.

    Product
    Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0045-2017·2016-10-12

    LDR Spine Recalls ROI-A Anterior Delivery Device Due to Binding

    LDR Spine USA is recalling 24 units of the ROI-A Anterior Delivery Device because the T-handle rotation has experienced binding. No patient injuries have been reported.

    Product
    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0015-2017·2016-10-12

    Siemens Recalls Ysio Max Radiographic Systems Due to Table Tilt Risk

    Siemens is recalling 37 Ysio Max radiographic systems because a table part may detach, causing the table to tilt and potentially injure patients.

    Product
    YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2307-2016·2016-10-12

    Four Seasons Pecan Tarts Recalled for Undeclared Milk

    Charlie's Specialties, Inc. is recalling Four Seasons Pecan Tarts because they contain undeclared milk. The product was distributed in Ohio.

    Product
    Four Seasons Pecan Tarts; 202 4T0867 ; Sel By: 09/10/2016, 09/15/15, 10/13/16,10/28/16; and 12/10/15, 12/15/15, 01/13/16, 01/28/16 (lot numbers). 180 Pieces; Weight 8#; Packed exclusively for International Market Brands, Cleveland, Ohio 44146.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0016-2017·2016-10-12

    Panoramic PC-1000 X-ray Systems Recalled for Safety Nut Defect

    Panoramic Rental Corp. is voluntarily correcting PC-1000 X-ray systems because a safety nut may be ineffective, posing a risk of blunt force trauma to the head, neck, or shoulders.

    Product
    Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2568-2016·2016-10-12

    Rabbit Creek Garlic & Cheese Bread Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Garlic & Cheese Olive Oil Bread Mix because the flour used may have been contaminated with E. coli O121.

    Product
    Garlic & Cheese Olive Oil Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15.5oz, UPC 010749009134
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2517-2016·2016-10-12

    Rabbit Creek Chocolate Cheesecake Brownie Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling 42 bags of Chocolate Cheesecake Brownie Mix because the flour used may be contaminated with E. coli O121.

    Product
    Chocolate Cheesecake Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 11.2oz, UPC 010749011595
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2488-2016·2016-10-12

    Rabbit Creek Blueberry Streusel Muffin Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Blueberry Streusel Muffin Mix because it may contain flour contaminated with E. coli O121.

    Product
    Blueberry Streusel Muffin Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15.3oz, UPC 010749011083
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2520-2016·2016-10-12

    Rabbit Creek Creme Brulee Brownie Mix Recalled for E. coli O121

    Rabbit Creek Products Inc. is recalling Creme Brulee Brownie Mix because the flour used may have been contaminated with E. coli O121.

    Product
    Creme Brulee Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 11.95oz, UPC 010749011502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2580-2016·2016-10-12

    Rabbit Creek Monkey Bread Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products Inc. is recalling Monkey Bread Quick Bread Mix because it may contain flour contaminated with E. coli O121.

    Product
    Monkey Bread Quick Bread Mix Cinnamon Pull-Apart, packaged in a plastic bag which is placed in a cardboard box, net wt. 16.5oz, UPC 010749008595
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2524-2016·2016-10-12

    Rabbit Creek Brownie Mix Recalled for E. coli O121 Contamination

    Rabbit Creek Products is recalling specific brownie mixes because the flour used may be contaminated with E. coli O121.

    Product
    Knock You Naked Brownie Mix (Chocolate Chips & Toffee), packaged in a plastic bag which is placed in a cardboard box, net wt. 13.75oz, UPC 010749111196
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0005-2017·2016-10-12

    Progressive Gourmet Recalls Sausage, Egg, and Cheese Muffins for Listeria Risk

    Progressive Gourmet Inc. is recalling frozen Sausage, Egg, and Cheese on English Muffin products manufactured for Starbucks due to Listeria monocytogenes contamination found on food contact surfaces.

    Product
    Sausage, Egg, and Cheese on English Muffin, Fully Cooked, Keep Frozen, Perishable-30/case Manufactured Exclusively for Starbucks Coffee Company, Seattle, WA 98134 Product Date: 10/FEB/2016 SKU: 11041857 Not Labeled for Retail Sale
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0035-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color D3 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling 18 units of Zenostar MT Color D3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2914-2016·2016-10-12

    New Star Lasers Recalls CT3Plus and CT3PZ Systems for Labeling Issues

    New Star Lasers is recalling 91 CT3Plus and CT3PZ laser systems because customers were not notified when promotional labeling was revised to remove outside-use indications.

    Product
    CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0012-2017·2016-10-12

    Philips Ingenuity CT Scanner Recalled for Infant Head Image Quality Issues

    Philips Medical Systems is recalling 235 Ingenuity CT scanners because infant head scans in High Resolution mode may produce degraded image quality, including non-uniformity and CT number shifts.

    Product
    Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product 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-0047-2017·2016-10-12

    Toshiba Aquilion RXL CT Scanner Recalled for Reconstruction Error

    Toshiba is recalling 165 Aquilion RXL CT scanners because a reconstruction error may interrupt scans if the range exceeds the maximum field of view.

    Product
    Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Food)·F-0002-2017·2016-10-12

    Ballester Hermanos Recalls Canned Octopus with Garlic Flavor Due to Mislabeling

    Ballester Hermanos, Inc. is recalling 495 cases of Coloso brand canned octopus with garlic flavor in Puerto Rico because the product contains squid instead of octopus.

    Product
    Product in cans of 4 1/4 oz and 8 1/4 oz net weight. Label reading in part as: "Coloso***PULPO AL AJILLO***OCTOPUS WITH GARLIC FLAVOR***NET WEIGHT ***Fabricado en Espa¿a (Manufactured in Spain)***Packed by: POYO PONTEVEDRA SPAIN***PACKED FOR COLOSO FOODS, INC.*** MERCADO CENTRA
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0001-2017·2016-10-12

    Ballester Hermanos Recalls Canned Octopus in Oil Due to Mislabeling

    Ballester Hermanos, Inc. is recalling canned octopus in oil because the product is actually squid. The recall covers Puerto Rico.

    Product
    Product in cans of 4 1/4 oz (111g) and 8 1/4 oz (220g) net weight. Label reading in part as: "Coloso***PULPO EN ACEITE***OCTOPUS IN OIL***NET WEIGHT ***Fabricado en Espa¿a (Manufactured in Spain)***Packed by: POYO PONTEVEDRA SPAIN***PACKED FOR COLOSO FOODS, INC.*** MERCADO CENT
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0033-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color C4 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling 10 units of Zenostar MT Color C4 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0046-2017·2016-10-12

    Toshiba Aquilion Lightning CT Scanner Recalled for Reconstruction Error

    Toshiba is recalling 165 Aquilion Lightning CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum Field of View.

    Product
    Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-2906-2016·2016-10-12

    Integra CUSA Dissectron Fingertip Laparoscopic Cannula Recalled for Packaging Seal Defect

    Integra LifeSciences is recalling 9 units of CUSA Dissectron Fingertip Laparoscopic Cannulas due to incomplete sterile packaging seals discovered during final inspection.

    Product
    CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0034-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color D2 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling 40 units of Zenostar MT Color D2 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2910-2016·2016-10-12

    Integra Lumbar Drainage Set Recalled Due to Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling specific lots of Lumbar Drainage Sets because final inspection revealed an incomplete packaging seal on the sterile product.

    Product
    Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch. One (1) sealed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0032-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color C3 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling 13 units of Zenostar MT Color C3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0004-2017·2016-10-12

    Ballester Hermanos Recalls Canned Octopus in Puerto Rico Due to Mislabeling

    Ballester Hermanos, Inc. is recalling 145 cases of canned octopus in Puerto Rico because the product contains squid instead of octopus.

    Product
    Product in cans of 4 1/4 oz and 8 1/4 oz net weight. Label reading in part as: "Coloso***PULPO EN SALSA MARINERA***OCTOPUS IN PICKLED SAUCE***NET WEIGHT ***Fabricado en Espa¿a (Manufactured in Spain)***Packed by: POYO PONTEVEDRA SPAIN***PACKED FOR COLOSO FOODS, INC.*** MERCADO C
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0029-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color B4 Dental Porcelain Liquid

    Ivoclar Vivadent is recalling 7 units of Zenostar MT Color B4 dental porcelain liquid due to packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0007-2017·2016-10-12

    Sun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

    Sun Pharmaceutical Industries is recalling 31,762 bottles of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0021-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color A1 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling Zenostar MT Color A1 dental porcelain coloring liquid because packaging leaks may cause skin irritation.

    Product
    Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0036-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color D4 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling 9 units of Zenostar MT Color D4 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color C1 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling 37 units of Zenostar MT Color C1 dental porcelain coloring liquid because packaging leaks may cause skin irritation.

    Product
    Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0011-2017·2016-10-12

    Philips Ingenuity Core 128 CT Scanner Recalled for Image Quality Defects

    Philips Medical Systems is recalling 524 Ingenuity Core 128 CT scanners because high-resolution head scans may produce degraded image quality, including non-uniformity and CT number shifts.

    Product
    Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product 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-2915-2016·2016-10-12

    New Star Lasers Recalls VariaBreeze Systems Due to Labeling Notification Failure

    New Star Lasers is recalling 17 VariaBreeze laser systems because customers were not notified when promotional material was revised to remove outside-use indications.

    Product
    VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0026-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color B1 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling 43 units of Zenostar MT Color B1 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0019-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color Impulse Grey Dental Porcelain

    Ivoclar Vivadent is recalling 60 units of Zenostar MT Color Impulse grey dental porcelain due to packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2907-2016·2016-10-12

    Integra Lumbar Drainage Set Recalled for Incomplete Packaging Seal

    Integra LifeSciences is recalling 18 units of Integral Lumbar Drainage Sets due to incomplete sterile packaging seals discovered during final inspection.

    Product
    Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0003-2017·2016-10-12

    Ballester Hermanos Recalls Canned Octopus in Hot Oil Due to Mislabeling

    Ballester Hermanos, Inc. is recalling 166 cases of canned octopus in hot oil sold in Puerto Rico because the label lists octopus but the product contains squid.

    Product
    Product in cans of 4 1/4 oz and 8 1/4 oz net weight. Label reading in part as: "Coloso***PULPO EN ACEITE PICANTE***OCTOPUS IN HOT OIL***NET WEIGHT ***Fabricado en Espa¿a (Manufactured in Spain)***Packed by: POYO PONTEVEDRA SPAIN***PACKED FOR COLOSO FOODS, INC.*** MERCADO CENTRA
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0027-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color B2 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling 15 units of Zenostar MT Color B2 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0018-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color Impulse Brown Dental Porcelain

    Ivoclar Vivadent is recalling 11 units of Zenostar MT Color Impulse brown dental porcelain due to potential packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0023-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color A3 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling 42 units of Zenostar MT Color A3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2833-2016·2016-10-12

    TriFoillmaging CT Scanners Recalled for X-Ray Compliance Issues

    Northridge Tri-Modality Imaging is recalling three TriFoillmaging Triumph/Triumph II Research CT scanners because they may not meet federal X-ray safety standards.

    Product
    TriFoillmaging Triumph/Triumph II Research CT scanners.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0048-2017·2016-10-12

    Toshiba Aquilion LB CT Scanner Recalled for Reconstruction Error

    Toshiba is recalling 165 Aquilion LB CT scanners because a reconstruction error may interrupt scanning if the range exceeds the maximum field of view.

    Product
    Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Food)·F-2642-2016·2016-10-12

    Coca-Cola Recalls Sprite Cans Due to Tab Opening Upward

    The Coca-Cola Company is recalling specific Sprite and Sprite Zero cans where the tab may open upward instead of downward, causing a loud pop.

    Product
    Sprite Zero, 12 oz. can/12 pack, UPC 049000037111; Sprite, 12 oz. can/6 pack, UPC N/A; Sprite, 12 oz. can/12 pack, UPC 049000028928; Sprite, 12 oz. can/20 pack, UPC 049000014655
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0025-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color A4 Dental Porcelain Liquid

    Ivoclar Vivadent is recalling 11 units of Zenostar MT Color A4 dental porcelain liquid due to potential packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0049-2017·2016-10-12

    Toshiba Celesteion CT Scanner Recalled for Potential Reconstruction Errors

    Toshiba is recalling 165 Celesteion CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum field of view.

    Product
    Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0028-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color B3 Dental Porcelain Liquid

    Ivoclar Vivadent is recalling 27 units of Zenostar MT Color B3 dental porcelain liquid due to potential packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0050-2017·2016-10-12

    Randox IgE Calibrator Series Recall for Value Alignment

    Randox Laboratories is recalling IgE Calibrator Series units to align value assignments with the 3rd International Standard for human serum IgE.

    Product
    IgE Calibrator Series
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0042-2017·2016-10-12

    Wegmans Italian Classics Ricotta & Spinach Ravioli Recalled for Plastic Contamination

    Wegmans is recalling Italian Classics Ricotta & Spinach Striped Jumbo Ravioli because the product may contain pieces of white plastic.

    Product
    Wegmans ITALIAN CLASSICS RICOTTA & SPINACH STRIPED JUMBO RAVIOLI, NET WT 9 OZ. (255g), UPC 0-77890-38934, KEEP REFRIGERATED -- Distributed By: Wegmans Foods Markets, Inc. Rochester, NY 14603, Product of Canada --- Packaged in a plastic tray and sold in a refrigerated case in the
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0005-2017·2016-10-12

    Teva Recalls Claravis Isotretinoin Capsules Due to Impurity Failures

    Teva North America is recalling Claravis (isotretinoin) capsules because they failed impurity and degradation specifications.

    Product
    Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0022-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color A2 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling Zenostar MT Color A2 dental porcelain coloring liquid because packaging leaks may cause skin irritation.

    Product
    Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0037-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color Impulse Orange Dental Porcelain

    Ivoclar Vivadent is recalling 5 units of Zenostar MT Color Impulse orange dental porcelain due to potential packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0017-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color Impulse Blue Dental Porcelain

    Ivoclar Vivadent is recalling 79 units of Zenostar MT Color Impulse blue dental porcelain due to packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2017·2016-10-12

    Philips CT Scanner Recall for Infant Head Image Quality Defects

    Philips is recalling 358 Ingenuity Core CT scanners because infant head scans may show degraded image quality, including non-uniformity and CT number shifts.

    Product
    Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product 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-0024-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color A3.5 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling 17 units of Zenostar MT Color A3.5 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2911-2016·2016-10-12

    Arrow Recalls Walrus Arterial Embolectomy Catheters Due to Labeling Errors

    Arrow International Inc is recalling 2,425 Walrus Arterial Embolectomy Catheters nationwide due to incorrect labeling.

    Product
    Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0009-2017·2016-10-12

    Philips Brilliance 64 CT Scanner Recalled for Infant Head Image Quality Issues

    Philips Medical Systems is recalling 185 Brilliance 64 CT scanners because infant head scans in High Resolution mode may show degraded image quality.

    Product
    Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product 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-0002-2017·2016-10-12

    Merit Medical Recalls Inflation Syringe Kits Due to Labeling Errors

    Merit Medical Systems is voluntarily recalling 1,297 Inflation Syringe Kits because unit labels are missing required device information.

    Product
    Merit Inflation Syringe Kit. Catalog Number KOS-02857
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0020-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color Impulse Violet Due to Packaging Leaks

    Ivoclar Vivadent is recalling 25 units of Zenostar MT Color Impulse violet dental porcelain coloring due to packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2916-2016·2016-10-12

    New Star Lasers Recalls ReNew Dermatology Devices for Labeling Errors

    New Star Lasers is recalling five ReNew laser systems because customers were not notified when promotional material was revised to remove outside-use indications.

    Product
    ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2641-2016·2016-10-12

    Coca-Cola Cans Recalled Due to Tab Opening Upward

    The Coca-Cola Company is recalling 14,168 cases of various soda cans where the tab may open upward instead of downward, causing a loud pop.

    Product
    Coca-Cola, 16 fl. oz. can/12 pack, UPC 049000054318; Coca-Cola, 12 oz. can/12 pack, UPC 049000028904; Coca-Cola Zero, 12 oz. can/12 pack, UPC 049000042559; Diet Coke, 12 oz. can/24 pack, UPC 049000010633; Diet Coke, 12 oz. can/12 pack, UPC 049000028911; Cherry Coke, 12 oz. can/12
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0031-2017·2016-10-12

    Ivoclar Vivadent Recalls Zenostar MT Color C2 Dental Porcelain Coloring Liquid

    Ivoclar Vivadent is recalling 19 units of Zenostar MT Color C2 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.

    Product
    Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2912-2016·2016-10-12

    Siemens RAPIDPoint 400 Cartridges Recalled for Chloride Calibration Error

    Siemens is recalling RAPIDPoint 400 Measurement Cartridges because of an error in the value assignment for Chloride calibrators.

    Product
    Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
    Category
    Medical Device
    Distribution
    Distributed nationwide

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