The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.
Iowa Select Herbs LLC, Bitter Melon (Momordica charantia, www.iowaselectherbs.com, 32 fl. Oz., Cedar Rapids, IA 52402
Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.
Iowa Select Herbs LLC, Echinacea Purpurea,  www.iowaselectherbs.com, (a) 1 fl. Oz., (b) 4 fl. Oz., (c) 16 fl. Oz. (d) 1 gallon, Cedar Rapids, IA 52402
(a) 2 bottles, (b) 2 bottles, (c) 1 bottle, (d) 1 bottle
Iowa Select Herbs LLC, Alcohol-Free, Bayberry Root, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC,Atractylodes (Atractylodes macrocephala), www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Aloe Vera Juice (Aloe barbaderis mill), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Yohimbe Bark (Pausinystalia Yohimbe),  www.iowaselectherbs.com, (a) 2 fl. Oz., (b) 4 fl. Oz., (c) 1 gallon, Cedar Rapids, IA 52402
(a) 1 bottle, (b) 2 bottles, (c) 1 bottle
Iowa Select Herbs LLC, Fennel Seed (Foeniculum vulgara),  www.iowaselectherbs.com,  4 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Kava Kava Root (Piper methysticum), www.iowaselectherbs.com, (a) 2 fl. Oz., (b) 4 fl. Oz., (c) 16 fl. Oz., Cedar Rapids, IA 52402
(a) 1 bottle, (b) 26 bottles, (c) 2 bottles
Iowa Select Herbs LLC, Papaya Leaf (Carica papaya), www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz. (c) 16 fl. Oz. (d) 32 fl. Oz. (e) 32 & 16 fl. Oz. (f) 128 fl. Oz. (g) 164 fl. Oz. (h) unknown size, Cedar Rapids, IA 52402
(a) 10 bottles, (b) 375 bottles, (c) 347 bottles, (d) 65 bottles, (e) 1 bottle, (f) 1 bottle, (g) 1 bottle, (h) 5 bottles
Iowa Select Herbs LLC, Alcohol-Free, Raspberry Leaf,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Rhubarb Root (Rhizoma rhei),  www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Chaparral Leaf (Larrea tridentata), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Alcohol-Free, Papaya Leaf, www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz. (c) 12 fl. Oz. (d) 16 fl. Oz. (e) 32 fl. Oz. (f) 128 fl. Oz. (g) unknown size, Cedar Rapids, IA 52402
(a) 5 bottles, (b) 93 bottles, (c) 1 bottle, (d) 23 bottles, (e) 19 bottles (f) 1 bottle (g) 4 bottles
Iowa Select Herbs LLC, Valerian Root (Valeriana officinalis),  www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Saw Palmetto Berry (Serenoa repens),  www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 16 fl. Oz., (c) 32 fl. Oz., (d) unknown size., Cedar Rapids, IA 52402
(a) 10 bottles, (b) 7 bottles, (c) 1 bottle, (d) 2 bottles
Iowa Select Herbs LLC, Beet Root (Beta vulgaris), www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Alcohol-Free, Cyperus Leaf,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Damiana Leaf (Turnera diffusa),  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Alcohol-free, Sage Leaf,  www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Alcohol-Free, Chicory Root, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Juniper Berry (Juniperus communis), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC,  Yucca Root (Yucca aloifolia) www.iowaselectherbs.com, 1 Gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Cat's Claw (Uncaria tomentosa), www.iowaselectherbs.com, 7.5 Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Artichoke Leaf (Cynara Scolymus), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Burdock Root, www.iowaselectherbs.com, 4 fl. Oz.., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Alcohol Free, Milk Thistle, www.iowaselectherbs.com, 16 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Fenugreek Seed (Trigonella foenum-graecum),  www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz., (c) 16 fl. Oz, (d) 32 fl. Oz., Cedar Rapids, IA 52402
(a) 1 bottle, (b) 33 bottles, (c) 3 bottles, (d) 2 bottles
Iowa Select Herbs LLC, Black Cohosh Root, www.iowaselectherbs.com, 1 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Yarrow Flowers (Achillea millefolium),  www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Black Currant (Ribes nigrum), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Schizandra Berry (Fructus schizandrae),  www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Dandelion Root,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Atragalus Root (Astragalus Membranaceus), www.iowaselectherbs.com, (a) 1 fl. Oz., (b) 2 fl. Oz., (c) 4 fl. Oz., and (d) 7.5 fl. Oz., Cedar Rapids, IA 52402
(a) 2 bottles, (b) 1 bottle, (c) 10 bottles, (d) 1 bottle
Iowa Select Herbs LLC, Licorice Root (Glycyrrhiza glabra), www.iowaselectherbs.com, (a) 2 fl. Oz., (b) 4 fl. Oz., (c) 16 fl. Oz., Cedar Rapids, IA 52402
(a) 2 bottles (b) 127 bottles (c) 1 bottle
Iowa Select Herbs LLC, Alcohol-Free, Magnolia Bark  www.iowaselectherbs.com, 1 Gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Jerusalem Artichoke www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Acia Berry (Euterpe oleracea), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Lemon Balm Leaf (Melissa officinalis), www.iowaselectherbs.com, (a) 1 fl. Oz., (b) 4 fl. Oz., (c) 8 fl. Oz., (d) 16 fl. Oz., (e) 32 fl. Oz., Cedar Rapids, IA 52402
(a) 1 bottle, (b) 6 bottles, (c) 1 bottle, (d) 3 bottles, (e) 1 bottle
Iowa Select Herbs LLC, Ziziphus (Zizyphus jujuba spinosa),  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Olive Leaf (Olea europa), www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 16 fl. Oz., (c) 1 gallon (d) Unknown size. Cedar Rapids, IA 52402
(a) 16 bottles, (b) 1 bottle, (c) 1 bottle, (d) 25 bottles
Iowa Select Herbs LLC, Grape Seed Leaf (Vitis vinifera), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Suma Root,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Hawthorn Berry (Crateagus oxycanthus), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Bilberry Leaf (Vaccinium myrtulli), www.iowaselectherbs.com, (a) 4 fl. Oz. and (b) 1 gallon , Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Momordica Leaf, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Cascara Root (Rhamnus purshiana), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Cudweed,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Eleuthero Root (Eleutherococcus senticosus),  www.iowaselectherbs.com,  7.5 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, St John's Wart,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Quack Grass,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC,Citrus Peel (Uncaria tomentosa), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Cold Be Gone, www.iowaselectherbs.com, (a) 1/2 fl. Oz., (b) 15 ml, (c) 1 fl. Oz., (d) 30 ml (e) unknown size, Cedar Rapids, IA 52402
(a) 108 bottles, (b) 6 bottles, (c) 184 bottles, (d) 1 bottle, (e) 1 bottle
Iowa Select Herbs LLC, Chamomile Flowers (Chamomilla recutita), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Propolis (Ligustrum lucidum), 4 fl. Oz., www.iowaselectherbs.com, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Organic Papaya Leaf (paw paw/papain), 500 mg, 60 Capsules, www.iowaselectherbs.com, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Elderberry Fruit (Sambucus nigra),  www.iowaselectherbs.com, (a) 1 fl. Oz., (b) 7.5 fl. Oz., (c) 16 fl. Oz., Cedar Rapids, IA 52402
(a) 1 bottle, (b) 1 bottle, (c) 1 bottle
Iowa Select Herbs LLC,  Magnolia Bark  www.iowaselectherbs.com, 1 Gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Alcohol-Free, White Willow Bark,  www.iowaselectherbs.com, (a) 16 fl. Oz. (b) 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Scullcap (Scutellaria lateriflora),  www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Dandelion Leaf (Taraxacum officinale),  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Alfalfa Leaf (Medicago sativa), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Osha Root (Ligusticum porteri), www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 16 fl. Oz. (c) 1 gallon, (d) unknown size, Cedar Rapids, IA 52402
(a) 31 bottles, (b) 1 bottle, (c) 2 bottles, (d) 1 bottle
Iowa Select Herbs LLC, Oregano Leaf (Origanum vulgare), www.iowaselectherbs.com, 1 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Muira Puama (Ptychopetalum ovata), www.iowaselectherbs.com, (a) 1 fl. Oz. (b) 2 fl. Oz. (c) 4 fl. Oz. (d) 1 gallon, Cedar Rapids, IA 52402
(a) 2 bottles, (b) 1 bottle, (c) 18 bottles, (d) 1 bottle
Iowa Select Herbs LLC, Wormseed,  www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Ginger Root (Zingiber officinale),  www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz. (c) 7.5 fl. Oz., (d) 1 gallon, Cedar Rapids, IA 52402
(a) 1 bottle, (b) 1 bottle, (c) 1 bottle, (d) 20 bottles
Iowa Select Herbs LLC, Hibiscus Flowers (Hibiscus sabdariffa), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, White Peony Root (Paeonia lactiflora),  www.iowaselectherbs.com, (a) 1 fl. Oz. (b) 4 fl. Oz., (c) 16 fl. Oz., (d) 32 fl. Oz., (e) 40 fl. Oz., (f) unknown size, Cedar Rapids, IA 52402
(a) 10 bottles (b) 65 bottles (c) 2 bottles (d) 1 bottle (e) 1 bottle (f) 1 bottle = 80 bottles
Iowa Select Herbs LLC, Sangre De Grado (Rhizoma rhei),  www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Oatstraw (Avena sativa), www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 16 fl. Oz., (c) 32 fl. Oz., (d) 128 fl. Oz. Cedar Rapids, IA 52402
(a) 28 bottles, (b) 76 bottles, (c) 3 bottles, (d) 1 bottle
Iowa Select Herbs LLC, Lobelia Leaf, (Lobelia inflata) www.iowaselectherbs.com, 1 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Psoralea Seed (Psoralea corylifolia), 1 gallon, www.iowaselectherbs.com, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Sassparilla Smilax uti lis,  www.iowaselectherbs.com, 7.5 fl. Oz.., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Alcohol-Free, Dandelion Root,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Red Ginseng Root (Panax ginseng), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Garcinia Fruit (Garcinia cambogia),  www.iowaselectherbs.com, (a) 1 fl. Oz. (b) 4 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Ashwaganda Root (Withania somnifera), www.iowaselectherbs.com, (a) 1 fl. Oz. and (b) 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Cranberry,  www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Goldenseal Root (Hydrastis canadensis),  www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 32 fl. Oz. (c) 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Reishi Mushroom (Ganoderma Lucidum),  www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Milk Thistle Seed (Carduus marianus), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., (c) 32 fl. Oz., Cedar Rapids, IA 52402
(a) 2 bottles, (d) 97 bottles (c) 1 bottle
Iowa Select Herbs LLC, Blood Root (Sanguinaria canadenix), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Marshmallow Root  (Althaea officinalis), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Broad Beans, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Buchu Leaf, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Organic Cold-Pressed Pomegranate Oil, 7.5 fl. Oz., www.iowaselectherbs.com, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Jewel Weed, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Gymnema Sylvestre (Gymnena sylvestre), www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Ginkgo Leave (Ginkgo biloba),  www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Arnica Flowers, www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Alisma Leaf, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Boswellia Serrata, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Rhodiola Root,  www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Acerola Berry (Malpighia), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Tumeric,  www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Cinnamon Bark (Cinnamomum cassia), www.iowaselectherbs.com, (a) 1 fl. Oz..(b) 4 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Alcohol-Free, Cilantro Leaf, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Solomon Seal,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Pygeum Bark,  www.iowaselectherbs.com, (a) 4 fl Oz. (b) unknown size, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Alcohol-Free, Dulse Leaf,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Nettle Leaf (Urtica dioica), www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 7.5 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Geen Tea Leaf, www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
(Annona muricata), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., Cedar Rapids, IA 52402
Iowa Select Herbs LLC, Propolis Resin (Ligustrum lucidum), 2 fl. Oz., www.iowaselectherbs.com, Cedar Rapids, IA 52402
Product was shipped to the following states:: AL, AR, GA, IL, IN, KS, KY, LA, MI, MO, MS, NE, OH, SC, TN, TX, VA & WV.
Kroger Raw #4 Macadamia Nuts. UPC 2 04192 51053 2 Dist. by the Kroger Company Cincinnati, Ohio 45202
Positive Salmonella sample results in Kroger brand raw Macadamia nuts
MAKOplasty Hip Array Kit Laminate 150230
Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.
TRIGAL*** Empanadillas Sabor a Carne (meat flavored turnovers)***Peso neto 3 lbs (Net Weight 3 pounds)*** Pqte. de 12 (12 units package)***Pastry Foods Inc. Rio Piedras PR
Undeclared Food Allergens: yellow #5, soy protein
Undeclared Food Allergens: Sodium metabisulfite
Rellenos de Papa (meat flavored potato balls): This product is distributed without label.
Undeclared Food Allergens: yellow #5, soy protein, and sodium bisulfite
Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI.    Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize   Product Usage:  Indicated to aid in tissue retraction during a surgical procedure.
The firm received a complaint of an open pouch which breaches the sterilization validation.
Wilson Implantation System    Product Usage:  Indicated to aid in tissue retraction during a surgical procedure.
Worldwide Distribution - US (Nationwide) and Internationally to the following countries:  AUSTRIA  CANADA  CHINA  FRANCE  GERMANY  INDIA  IRELAND  ITALY  KOREA  MALAYSIA  NETHERLANDS  NORWAY  RUSSIA  SINGAPORE  SPAIN  SWITZERLAND  UNITED KINGDOM
Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
Software Versions: Version 1.6.1 and 1.6.2
United states and Canada, Mexico and Peru.
Roasted No Salt  Inshell Pistachios:  Packaged under brand name of  Wonderful.    Packed in 16 oz., 8 oz., 200 grams and 225 grams bags.    UPC - 16 oz: 014113910064  UPC - 8 oz:.014113910187  UPC - 200 grams: 014113913652  UPC - 225 grams: 014113912532
Firm is recalling all Pistachio products produced in one of their  processing buildings in a two week time frame due to a link with a current outbreak of Salmonellosis.
Dry Roasted & Salted Inshell Pistachios;  Packaged for Trader Joe's.  Packaged in 16 oz. bag.    UPC 00079983
Roasted Salt and Pepper Inshell Pistachios:  Packaged under brand name of  Wonderful.    Packed in 4.50oz. bag.    UPC - Bag  014113910293,   Outer Box UPC: 014113913362
4.5 oz bag lot code 1510123307001, Expiry date 2016 NOV 05.
50% Less Salt Dry Roasted & Salted Inshell Pistachios;  Packaged for Trader Joe's.  Packaged in 16 oz. bag.    UPC 00111348
Roasted Salted Inshell Pistachios:  Packaged under brand name of  Wonderful, Paramount   Packed in 1.5 oz., 24 oz., 5 oz., 13 oz., 40 oz., 1 oz,. bags and 25 lb. box.    UPC - 1.5 oz. bag: 014113911856  Outer Box UPC: 014113911863    UPC 24 oz. bag: 014113911979    UPC 5 oz. bag: 014113910088  Outer box UPC: 014113910156    UPC 13 oz. bag: 014113913706    UPC 40 oz. bag: 014113913638    UPC 1 oz. bag: 014113912839  UPC Outer Box: 014113910323    UPC 25 lbs box: 00014113910255
Dry Roasted & Unsalted Inshell Pistachios;  Packaged for Trader Joe's.  Packaged in 16 oz. bag.    UPC 00079990
Roasted Salted Shelled Pistachios  Packaged under brand name of  Wonderful   Packed in 6 oz.., 2.5 oz., 24 oz., 6 oz., 225 g  bags.     UPC - 6 oz. bag 014113734066    UPC 2.5 oz. bag 014113910132  Outer box UPC 014113913386    UPC 24 oz bag 014113910125    UPC  6 oz. bag 014113734066    UPC 225 g 014113912044
Roasted Sweet Chili Pistachios  Packaged under brand name of  Wonderful   Packed in 1.25 oz., 4.5 oz. bags.     UPC - 1.25 oz bag 014113913331;  Outer box UPC 014113913348    UPC 4.5 oz bag 014113910309  Outer box UPC 014113913379
1.25 oz bag lot code 1510123307901, Expiry date 2016 NOV 04.    4.5 oz. bag lot code 1510123308101, Expiry date 2016 NOV 05.
US consignees: Arizona, California, Delaware, Florida, Georgia, Illinois, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington.
The instructional insert for the In Touch Control  Solution for use with the In Touch meter and In Touch strips as a quality control check  did not contain the limitation of sensor accuracy:   (1) with the use of acetaminophen (Tylenol)  (2) with the use of Ascorbic Acid (vitamin C) supplementation  (3) in the presence of uric acid
Test Valley LLC. dba. Amniotic Therapies LLC.
Ohio; Texas; New Mexico; Hawaii; New Jersey; Florida; Georgia
Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
6% Hetastarch in 0.9% Sodium Chloride Injection, 500 mL, NOVAPLUS, NDC: 0409724849;  HEXTEND, 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, NDC: 0409155554
NOVAPLUS (5148 units); HEXTEND( 9156 units)
Hetastarch products, with potential contact of products with an aromatic hydrocarbon resin during manufacturing, were distributed.
NOVAPLUS, NDC: 0409724849;  Lot Number:  50087JT  HEXTEND, NDC: 0409155554; Lot Number 5180JT
VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712.  VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae  to Minocycline.
Worldwide Distribution - USA (nationwide) Distribution to the states of :  MO, NE, AL, PA, IL, MN, TX, ID, CO, UT, NV, CA, NY, RI, OR, NJ, AZ, GA, IN, VA, LA, NM, MD and AR., and to the countries of :  Canada, Austria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, United Kingdom, Italy, Netherlands, Norway, Spain, Sweden, United Arab Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Croatia, Malta, Iceland, Brazil, Thailand, Philippines, Peru, Honduras, Mexico, Kenya, Israel, Romania, Russia, Poland, Turkey, Australia, New Zealand, China, Hong Kong, South Africa, India, Korea, Singapore and Taiwan.
Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.
Part Number: 903-111  Lot Number: Below R0174
Nationwied to the following states: FL, PA, NY
Hot smoked Atlantic Ocean Perch, vacuumed package, one fish per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009
The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products.
Lot code is also expiration date: 0328PH (exp 03/28/2016)
Salted Herring in pail, 30 pieces per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009
The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood , and the salted herring were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products and the salted herring.
Cold smoked white fish, vacuum packaged, one fish per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009
Hot smoked Escolar chunks, vacuum packaged, one chunk per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009
Lot code is also expiration date: 0217E (exp 02/17/2016)
Cold smoked Saira (Saury), vacuum packaged, 3 pieces per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009
Lot code is also expiration date: 0328SR (exp 03/28/2016)
Cold smoked sliced Salmon 8 oz and 1 lb, vacuum packaged.  Manufactured by North Fish USA, Pembroke Pines, FL 33009
Salted Mackerel, vacuum packaged, one fish per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009
Hot smoked Mackerel, vacuum packaged, one fish per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009
Cold smoked Sliced Fish Assorted (cold smoked Salmon and Escolar), 8 oz and 1 lb, vacuum packaged.  Manufactured by North Fish USA, Pembroke Pines, FL 33009
Cold smoked Mackerel, vacuum packaged, one fish per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009
Sliced cold smoked Escolar, 8 oz and 1 lb, vacuum packaged.  Manufactured by North Fish USA, Pembroke Pines, FL 33009
Worldwide Distribution: US (nationwide) and countries of:  Australia, Great Britain and Canada.
Alaris PC unit, Model 8015    The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.
Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall.  and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR  and AUSTRALIA..
On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the  traction splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. The packaging labeled Adult  contained a pediatric splint strap and the packaging labeled pediatric  cont
On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. The packaging labeled Adult  contained a pediatric splint strap and the packaging labeled Pediatric  conta
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087,   NDC 46122-199-05,  ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle,  Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-0404-00.
10,060 bottles (Good Neighbor Pharmacy: 6,731 bottles/Premier Value Brand: 3,323 bottles)
Good Neighbor Pharmacy Batch Number 4H76A; Exp 07/16  Premier Value Batch Number 4H76B; Exp 07/16
Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA,  NDC 0409-6629-02
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Welltop Fried Dace, Net Weight 184g, Product of China, packed for Hui Zhou Welltop Foods Import and Export Co. Ltd. Importer: Guong Aik Sdn. Bhd No. 13 Long Bridge Road, PO Box 1056, 96008, Sibu, Sarawak, East Malaysia, Importer Strong America Ltd, 2-39 54th Ave., Long Island City, NY
FDA sampling discovered the presence of leucomalachite green
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Reports of failure of the device's power supply.
Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only,  Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.
21 bottles (910 extended release tablets)
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Domestic: MI, OH, WI, KY, IN, IL    Foreign: None; VA/DOD: None
Meijer Plain Knot Rolls, 8 ct., Net Wt. 10 oz.; 12/case, 9.4 lbs/case
The lot number on the master case 16061 with a production date of 3/1/16. Product number 2035; the UPC code is 0-41250-09971-0 and is located at the bottom of the package label underneath the bar code
Assorted Dinner Rolls, 128 ct., Net Wt. 10.2 lbs; 16/ 8 ct./case
and 8 ct. packages of Assorted Dinner Rolls 128 ct. because they may contain trace amounts of undeclared peanuts.
The lot number is 16041 with a production date of 2/10/16; Product number 4180. This information is found on the master case of the product.  This product does not have a UPC number
Blood products, in which donor screening/deferral screening not done or incorrectly performed were distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor whose physical examination was not documented, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
AL, AZ, CA, CO, GA, IA, IL, IN, KS, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TX, VA, WA, WI.
Emerald 100 Calorie Packs of Cashew Halves & Pieces, roasted and salted.  7 pack/ 0.62 oz. each (17.5 g).    Ingredients: Cashews, Vegetable Oil/Safflower, Sunflower and/or Canola Oil, Salt, Rosemary extract (to preserve freshness:    Retail Carton UPC: 0 10300 33324 1;  Inner Package UPC: 0 10300 33399 9;    Distributed by:  Diamond Foods, Inc., San Francisco, CA 94111.
There is the potential for small glass fragments in Emerald  100 calorie packs of cashews halves and pieces.
NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, Brazil, Bulgaria, Cambodia, Canada, Chad, Chile, China, Colombia, Croatia, Czech Rep., Djibouti, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Liechtenstein, Lithuania, Macao, Malaysia, Mexico, Montenegro, Myanmar (Burma), Nepal, Netherlands, New Zealand, Niger, Norway, Oman, Peru, Philippines,  Poland, Portugal, Romania, Russia, Saudi Arabia, Scotland, Serbia, Singapore, Slovakia, South Africa, South Korea,  Spain, Sri Lanka, Taiwan, thailand, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam.
CARESTREAM Image Suite V4;  Image Suite V4: DICOM STORE SCP:  REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop:  REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered  System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer:  Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. by: Carestream Health, Inc., 150 Verona Street, Rochester, NY 14608   --- CLASSIFICATION NAME: System, Image Processing, Radiological  The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States
CARESTREAM Image Suite V3:  MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608  --- CLASSIFICATION NAME: System, Image Processing, Radiological   The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.
Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX,  NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI
Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V  Product Code 710200K  Serial # >202169 and < 203249  The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Product Code 710200K, Serial Number Range; 202169 - 203249
Dialog+ Hemodialysis machines: Dialog A + HE/BIC  Product Code 710200L  Serial # >200318 and < 2039222  The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
Product Code 710200L, Serial Number Range 200318 -203922 distributed between 08/05/2013 - 07/07/2014.
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL  Product Code # 710200S  Serial # >200805 and <204001  The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
Product Code 710200S Serial Number Range; 200805-204001
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A  The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A  The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC  Product Code # 710200U  Serial # 202136 and < 203837  The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
Product Code 710200 USerial Number Range; 202136-203837
ALFALFA SEED, NET WT. 50 LB. International Specialty Supply LLC, Cookeville, TN
One sample taken were positive for Salmonella Poly B
La Fiesta Bean Salad (2/5 LB Tubs) Made By Fresh Creative Foods Moore, OK 73160 UPC 013454371763 packaged in white plastic tub with lid
Product ID #: 402690; Best if Used By: 05/07/2016, Lot: BFEGJD and Best if Used By: 05/11/2016, Lot: BFGHFE
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723.  An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.
Medtronic Inc., Cardiac Rhythm and Heart Failure
AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN.
Blood Systems, Inc. DBA United Blood Services
Blood product, for which donor eligibility was inadequately determined, was distributed.
Blood Systems, Inc. dba United Blood Services Texas
Apheresis Red Blood Cells, Leukocytes Reduced
Mislabeled RBC products were distributed.
Blood product, collected from a donor who was allowed to donate without a current physical, was distributed.
American Natl Red Cross Mid Atlantic Region
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Misbranded Blood Products were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product shipped nationwide to the following states: AZ, CA, FL, IA, IL, ME, MI, MO, NH, NJ, NY, PA, TN VA, WA, WI
Classic Creme Cookies, Net wt. 12 oz cartons, 6 cartons per case.  Manufactured for Back To Nature Foods Co., LLC
16,521 cases, 99,126 cartons (6 cartons per case).
UPC 819898011032, Lot code: 10 SEP 16 TBPC and 16 SEP 16 TBPC.  Lot code is also expiration date.    Expansion includes UPC 19898-01103 and lot codes 13 AUG 16, 08 OCT 16, 21 OCT 16, and 22 OCT 16.
American Red Cross Blood Svs. Indiana-Ohio Region
Blood product, for which donor suitability was inadequately determined, was distributed.
Plasma products, for which donor suitability was inadequately determined, were distributed.
Blood Products collected from a donor who traveled to a malaria endemic area were distributed.
HCSC-Blood Center dba as Miller-Keystone Blood Center
QTrade Teas & Herbs is recalling Organic Chamomile Tea Bag Cut (TBC) because it has the potential to be contaminated with Salmonella.
Philips Electronics North  America Corporation
Worldwide Distribution - US including OH, CA, NC and Internationally to China, Iraq, Japan, and Korea.
HeartStart MRx Monitor/Defibrillator  The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.
The product was distributed to one Manufacturer in New Jersey.     Harris Freeman (Southern Tea Company)  344 New Albany Road   Moorestown, New Jersey 08057
Organic Lemon Myrtle packed in a 12.5kg plastic bag inside of a cardboard box.
The Organic Lemon Myrtle tested positive for Salmonella.
Worldwide distribution.  US nationwide, Austria, Canada, China, Germany, India, Italy, Spain, Sweden, and Switzerland.
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M.  Model number: 10433816.
While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of view, or the RES region of interest with the trackball.
Worldwide Distribution: US (Nationwide) and countries of: Canada, China, Hong Kong, Indonesia, India, Japan, Korea, Malaysia, New Zealand, Singapore, Thailand, Taiwan, United Arab Emirates, Austria, Belgium, Bulgaria, Switzerland, Czech Republic, Germany, Denmark, Algeria, Spain, Finland, France, United Kingdom, Greece, Hungary, Ireland, Israel, Iraq, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sweden, Turkey, South Africa.
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206    The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.
Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212    The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
NY, NJ, CT, MA, PA, IL, MD, VA, KY, SC, GA, FL, and CA.
NORVEN herring in oil, Net Wt. 17.6 oz. (500g), UPC barcode 856687004196, and Net Wt. 10.6 oz. (300g), UPC barcode 856687004189 -- Product of Ukraine -- Distributed by: OLMA-XXI Inc. 204 28th Street, Brooklyn, NY 11232
The lot was found to be contaminated with Listeria monocytogenes based on FDA sampling and analysis.
Lot # 530611, Best before: 10/27/16 (stamped on bottom label).
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM.  Intended for use in neurosurgery.
Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
Product Catalog Number: 10BA40D, Lot Number: H5237248
Cha-Ching Original Potato Chips Net Wt 10 OZ.;  Distributed by OZA Brands, LLC, Salisbury, NC 28147
Original Potato Chip packaging was filled with BBQ Seasoned product. Ingredient statement does not declare wheat allergen.
Blood product, collected from a donor who was not deferred or follow up questions were not asked, was distributed.
s use of the system.     The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator.  In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs
If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (lPG). This may result in the user being unable to recharge the lPG.  This safety notice only applies to CPs Model 4500.
Blood Systems, Inc.  dba UBS - California
Apheresis products collected from donors taking Propecia and Accutane were distributed.
W042216008002E (double collection); W042216008011C(double collection)
Central Texas Regional Blood & Tissue Center
Apheresis red cells, not meeting product specifications, were distributed.
Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI
Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Thin Egg Noodle (Mi Trung Ga), 5lbs, 8 units/case
Sincere Orient Food is recalling the Thin Egg Noodle (Mi Trung Ga) because it contains undeclared wheat.
Red Blood Cell product collected from a donor who traveled to a malarial endemic area was distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN.
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.
The docking station top cover of the removable patient table may contain a magnetic metal plate.  When docking/undocking the table, the magnetic top cover may become attracted to the magnet.
Worldwide Distribution - US including FL, GA, NC, and TX and Internationally to  AUSTRALIA, CANADA, CHINA, FRANCE, GERMANY, ITALY, JAPAN, REPUBLIC OF KOREA, NORWAY, PERU, SWEDEN UNITED ARAB EMIRATES, UNITED KINGDOM.
GE, Revolution CT.  The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.
Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B  This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.
Potential degradation of detector performance.
Lifesouth Community Blood Centers - Montgomery Region
Plateletpheresis product, not meeting firm specifications, were distributed.
American Red Cross Blood Services Tennessee Valley Region
Blood product, collected from an ineligible donor, was distributed.
Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0
Labeling: Not elsewhere classified - count on the label was incorrect.
Human tendon allografts, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.