Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
US: Nationwide (AL, AR, AZ, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, OH, OK, PA, SC, SD, TN, TX, VA, WI)
Chocolate covered wafers (Bocadin) in plastic packaging sold under the Mi Costenita brand and packaged and distributed by Yoli, Inc.
Undeclared Allergens (Milk): Mi Costenita BOCADIN wafer with chocolate contains undeclared milk allergens.
Golden Chocolate ROGALIK PAPAYA, Net Wt. 1Lb. (454 g).  Manufactured for and Distributed by: Golden Chocolate, Brooklyn, NY 11231.
Golden Chocolate International, Inc. has recalled (3) products due to the use of undeclared FD&C Yellow #5, FD&C Yellow #6, and FD&C Red #40 food colorings.
Golden Chocolate RAISIN POUND CAKE, Net Wt. To be Weighed at Time of Sale.  Manufactured for and Distributed by: Golden Chocolate, Brooklyn, NY 11231.
Golden Chocolate OREX, Net Wt. 1Lb (454 g).  Keep Refrigerated.  Manufactured for and Distributed by: Golden Chocolate, Brooklyn, NY 11231.
WI, MD, CA, AR, FL, HI, MA, NC, NJ, IL, OH, UT, MN, NY, MI, MS, MO, RI, TX, and Switzerland
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Blood and Blood Products for Reprocessing
AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MN, MO, MS, NC, NE, NY, PA, OH, OK, OR, SC, TX, VA, TN UT, and WA.
Epi breads, 7'' French Hoagie Sliced, Net Weight 10.4 lbs., Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Undeclared allergen: Bread products were manufactured using raw material (wheat gluten) that was recalled due to undeclared peanut and/or tree nut residue.
Epi breads, French Baguette Unsliced, 24 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Epi breads, 10'' French Mini-Baguette, 54 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Epi breads, 7'' Sourdough Hoagie, 72 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Epi breads, 12'' French Sub-roll, 36 count per case, Epi breads, 12'' Unsliced French Hoagie, 45 count per case, and 7.75'' French Hoagie, 48 count per case per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236
Epi breads, 8'' Sub-roll, 48 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Epi breads, Sliced Multigrain Boule, 48 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Epi breads, Italian Loaf, Net Weight 12.0 lbs, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Epi breads, 12'' White Hoagie Sliced, 45 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Epi breads, 7'' Extra Wide and 7'' Extra Wide Sliced Hoagie  54 count per case, 4 case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Epi breads, Garlic Italian Bread, 14.6 lbs., Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Epi breads, Foot Long Sub Roll, Net Weight 11.6 lbs, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236
Epi breads, 8'' Extra Wide Sliced Hoagie, 7'' Hoagie Butterfly Sliced,  54 count per case and 9.5'' Crusty Hoagie, 45 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Epi breads, 7'' Wheat Hoagie Wide, Net Weight 10.8 lbs, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Epi breads, 7.75'' Sliced Wheat Hoagie, 54 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Charleys, 7.75'', 9'' and 12'' Fresh Baked Hoagie Sliced, 96, 64 and 60 count case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Fire House Subs, Medium White Sub Roll, and Large White Sub Roll, 48 and 45 count case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Fire House Subs, Medium Wheat Sub Roll, and Large Wheat Sub Roll, 48 and 45 count case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Zaxbys, Nibbler Bun, 180 count case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Zaxbys, Brioche Bun, 90 count case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Popeyes, 12'' Po Boy Bread, 45 Pieces per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
Walmart brand bread, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236
Item code; 552209077, Reference no. 11106.
Worldwide Distribution-US (nationwide) including the states of  MI & PA, and the countries of Belgium, England, Italy, Czech Republic, Turkey, Greece, Ireland, Scotland, Spain, and Lebanon.
Steriseal-Cannula Ophthalmic; Section 886.4350, Class 1 HMX.    Bi-Manual Irrigating/Aspirating Handpiece.
The firm is initiating this recall because it was alleged that the metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
FL, GA, SC, NC, VA, OH, KY, TN, AL, MS, IN, IL, MT, AR, LA, TX, Ok, KS, NM, CO, WY, AZ, NV and Bermuda, Belize, Saudia Arabia, Yemen, Oman, UAE, Qatar, Egypt, Jordan, Kuwait, Dominican Republic, Panama, Turks and Caicos, Haiti, Trinadad and Tobago, Puerto Rico, Chile, Peru, China, Mexico, Philippines, Tortola, St. Thomas and St. Croix, Anguilla, St, Kitts and Nevis, Montserrat, and Dominica
BLUE BELL COUNTRY COOKIE  VANILLA ICE CREAM & CHOCOLATE CHIP COOKIE SANDWICH   5.75 FL OZ (170 mL)
Five patients who were treated in a single hospital in Kansas were infected with one of four rare strains of Listeria monocytogenes.
BLUE BELL GREAT DIVIDE BAR  CHOCOLATE AND ARTIFICIALLY FLAVORED VANILLA FROZEN DESSERT WITH CHOCOLATE FLAVORED AND ARTIFICIALLY FLAVORED VANILLA COATING  2.75 FL OZ (81 mL)
BLUE BELL SOUR POP GREEN APPLE ARTIFICIALLY FLAVORED FROZEN JUICE SNACK BAR  2.5 FL OZ (73 mL)
BLUE BELL SOUR COTTON CANDY BAR  NATURAL AND ARTIFICIAL FLAVOR ADDED ICE CREAM BAR 2.5 FL OZ (73 mL)
SKU #216; All lots within expiry inlcuding 041516A, 042816A, 042916A, 043016A
Blue Bell Scoops (bulk)   The scoops are not individually labeled.  However, the ''PRODUCT INFORMATION SHEET''  which is included with the bulk product was provided by the firm.  It has information regarding the product.      Blue Bell Creameries, L.P.  P.O. Box 1807  Brenham, Texas 77834-1807 www.bluebell.com (979) 836-7977    PRODUCT INFORMATION SHEET     Blue Bell Scoops 4 fl. oz.    A rich and creamy vanilla ice cream that's pre-dipped in a ready-to-eat scoop.      Nutrition Facts  Serving Size 1 scoop (79 g) Servings 1  Calories 160 Fat. Cal 70       Amount/Serving       %DV*     Amount/Serving      %DV*  Total Fat 8 g              12%        Total Carb. 18 g 6%  Sat. Fat 5 g              25%       Fiber 0 g 0%  Trans Fat 0 g        Sugars 18 g  Cholest.. 30 mg         11%        Protein 4 g  Sodium 65 mg             3%    Vitamin A 6%    Vitamin C 0%     Calcium 15%     Iron 0%  *Percent Daily Values (DV) are based on a 2,000 calorie diet.       Ingredients:  Milk, cream, sugar, skim milk, high fructose corn syrup, corn syrup, natural and artificial vanilla flavor, cellulose gum, vegetable gums (guar, carrageenan, carob bean), salt, annatto color.    *Numbers rounded per FDA Nutrition Labeling Guidelines
The sticks are not individually labeled.  However, the ''PRODUCT INFORMATION SHEET''  which is included with the bulk product was provided by the firm.  It has information regarding the product.     Blue Bell Creameries, L.P.  P.O. Box 1807  Brenham, Texas 77834-1807 www.bluebell.com (979) 836-7977      PRODUCT INFORMATION SHEET Vanilla Ice Cream Stick Slices (Bulk) -- 4 fl. oz. bar      Vanilla ice cream on a stick.    Nutrition Facts  Serving Size 1 bar (66 g)  Servings 1 Calories 130 Fat. Cal 60    Amount/Serving %DV* Amount/Serving %DV*  Total Fat 7 g 10% Total Carb. 14 g 5%  Sat. Fat 4.5 g 22% Fiber 0 g                      0%  Trans Fat 0 g                      Sugars 12 g  Cholest. 25 mg 9% Protein 2 g  Sodium 55 mg 2%  Vitamin A 6% Vitamin C 0% Calcium 8% Iron 0%  *Percent Daily Values (DV) are based on a 2,000 calorie diet.  Ingredients:  Milk, cream, sugar, corn syrup, high fructose corn syrup, skim milk, whey, buttermilk, artificial flavor, cellulose gum, vegetable gums (guar, carrageenan, carob bean), soy mono- and diglycerides, polysorbate 60, xanthan gum, annatto color.    *Numbers rounded per FDA Nutrition Labeling Guidelines
BLUE BELL ALMOND BAR HOMEMADE BRAND VANILLA MADE WITH MILK CHOCOLATE AND ALMONDS   2.75 FL OZ (81 mL)
Blue Bell COTTON CANDY BARS Natural and Artificial Flavor Added Ice Cream Bars  6 - 2.5 FL OZ (73 mL) BARS 15 FL OZ (443 mL)  80 Calories Each
SKU #245; All lots within expiry including 041516A, 042816A, 042916A, 043016A
Blue Bell SOUR POPS GREEN APPLE Artificially Flavored Frozen Juice Snack Bars  High in Vitamin C  6 - 2.5 FL OZ (73 mL) BARS 15 FL 0Z (443 mL)  70 Calories Each
SKU #249; All lots within expiry including 121815A
Blue Bell No Sugar Added MOOO BARS Not a reduced calorie food.  See Nutrition information for calorie, sugar, total fat and saturated fat content.  Artificially Flavored Vanilla No Sugar Added Lowfat Ice Cream with Chocolate Flavored Coating  12 2 FL OZ (59 mL) 90 Calories Each
Blue Bell Ice Cream CHOCOLATE 3 FL OZ (88mL) Institutional/food service tab cups
Blue Bell Ice Cream STRAWBERRY FLAVORED NATURAL AND ARTIFICAL FLAVOR ADDED 3 FL OZ (88mL) Institutional/food service tab cups
Blue Bell Ice Cream VANILLA FLAVORED NATURAL AND ARTIFICIAL FLAVOR ADDED 3 FL OZ (88mL) Institutional/food service tab cups
Blue Bell Ice Cream Banana Pudding Natural and Artificial Flavor Added One Pint (473 mL)
Blue Bell Ice Cream Butter Crunch One Pint (473 mL) and Half Pint Size
Blue Bell Ice Mint Chocolate Chip One Pint (473 mL) and Half Pint Size
Blue Bell Ice Cream Cookies n' Cream One Pint (473 mL) and Half Pint Size
Blue Bell Ice Cream Homemade Vanilla One Pint (473 mL) and Half Pint Size
Blue Bell Ice Cream Dutch Chocolate One Pint (473mL) and Half Pint Size
Blue Bell Ice Cream Moo-llennium Crunch One Pint (473 mL)
Blue Bell Sherbet Rainbow Lime, Orange & Strawberry One Pint (473 mL)
Blue Bell  Sherbert Orange One Quart Naturally Low Fat
Blue Bell  Sherbert Orange Mixed Berries Strawberry & Raspberry NEW! NATURALLY LOW FAT One Quart
Blue Bell  Sherbert Rainbow 3 ounce tab lid cup, institutional/food service cup; Sherbert Orange 3 ounce tab lid cup, institutional/food service cup; Sherbert Lime 3 ounce tab lid cup, institutional/food service cup
Blue Bell Ice Cream The Original Homemade Vanilla Flavored Natural and Artificial Flavor Added Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Pistachio Almond Natural and Artificial Flavor Added Still a 1/2 Gal (2 QTS)
Blue Bell Light Ice Cream Homemade Vanilla Flavored Natural and Artificial Flavor Added 25% fewer calories and 55% less fat than regular ice cream HALF GALLON (1.89L)
Blue Bell Banana Split One Pint (473 mL)
Blue Bell Black Walnut One Pint (473 mL)
Blue Bell Buttered Pecan One Pint (473 mL)
Blue Bell Cherry Vanilla  One Pint (473 mL)
Blue Bell Chocolate Chip Cookie Dough  One Pint (473 mL) and Half Pint Size
Blue Bell Chocolate Peanut Butter One Pint (473 mL)
Blue Bell Coconut Fudge One Pint (473 mL)
Blue Bell Cotton Candy One Pint (473 mL)
Blue Bell Creole Cream Cheese One Pint (473 mL)
Blue Bell Happy Tracks One Pint (473 mL)
Blue Bell I Heart Chocolate One Pint (473 mL)
Blue Bell Italian Cream Cake One Pint (473 mL)
Blue Bell Krazy Kookie Dough One Pint (473 mL)
Blue Bell Magic Cookie Bar One Pint (473 mL)
Blue Bell Marbled Cream Cheese Brownie One Pint (473 mL)
Blue Bell Mardi Gras King Cake One Pint (473 mL)
Blue Bell Milk & Cookies One Pint (473 mL)
Blue Bell Mint Cookies 'n Cream One Pint (473 mL)
Blue Bell Mocha Almond Fudge One Pint (473 mL)
Blue Bell Orange Swirl One Pint (473 mL)
Blue Bell Pecan Pralines 'n Cream One Pint (473 mL)
Blue Bell Pistachio Almond One Pint (473 mL)
Blue Bell Red Velvet Cake One Pint (473 mL)
Blue Bell Red, White, & Blue Bell One Pint (473 mL)
Blue Bell Rockslide Brownie One Pint (473 mL)
Blue Bell Rocky Mountain Road One Pint (473 mL)
Blue Bell Sea Salt Caramel One Pint (473 mL)
Blue Bell Southern Blackberry Cobbler One Pint (473 mL)
Blue Bell Southern Peach Cobbler One Pint (473 mL)
Blue Bell Strawberries & Homemade Vanilla One Pint (473 mL)
Blue Bell The Great Divide One Pint (473 mL)
Blue Bell Ultimate Neopolitan One Pint (473 mL)
Blue Bell No Sugar Added Country Vanilla One Pint (473 mL)
Blue Bell Ice Cream Banana Split Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Birthday Cake Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Black Cherry Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Black Walnut Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Butter Crunch Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Buttered Pecan Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Caramel Turtle Cheesecake Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Cherry Vanilla Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Chocolate Covered Cherries Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Chocolate Decadence Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Chocolate Peanut Butter Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream I Heart Chocolate Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Italian Cream Cake Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Magic Cookie Bar Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Malt Shoppe Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Marbled Cream Cheese Brownie Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Mocha Almond Fudge Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Mocha Madness Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Moo-llenium Crunch Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Natural Vanilla Bean Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Nutty Chocolate Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Pecan Pralines 'n Cream Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Rockslide Brownie Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Rocky Mountain Road Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Rocky Road Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Southern Blackberry Cobbler Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Southern Hospitality Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Strawberry Cheesecake Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Tropical Paradise Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream White Chocolate Almond Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Banana Nut Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Banana Pudding Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Blueberry Cheesecake Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Caramel Sundae Crunch Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Century Sundae Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Chocolate Chip Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Chocolate Chip Cookie Dough Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Christmas Cookies Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Coconut Fudge Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Coffee Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Cookies 'n Cream Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Creole Cream Cheese Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Dos Amigos Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Dutch Chocolate Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream French Vanilla Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Fudge Divinity Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Gingerbread House Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Happy Tracks Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Homemade in the Shade Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Hot Fudge Brownie Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Kentucky Delight Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Key Lime Pie Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Krazy Kookie Dough Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Lemon Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Lemon Bliss Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Mango Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Mardi Gras King Cake Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Mexican Praline Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Milk & Cookies Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Milk Chocolate Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Milk Chocolate Chip Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Milk Cookies 'n Cream Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Orange Swirl  Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Peaches & Homemade Vanilla Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Peppermint Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Peppermint Bark Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Pineapples & Homemade Vanilla Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Red Velvet Cake Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Red, White & Blue Bell Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Rum Raisin Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Sea Salt Caramel Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Southern Peach Cobbler Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Spiced Pumpkin Pecan Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Strawberries & Homemade Vanilla Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Strawberry Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream The Great Divide Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Tin Roof Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Triple Chocolate Still a 1/2 Gal (2 QTS)
Blue Bell Ice Cream Ultimate Neopolitan Still a 1/2 Gal (2 QTS)
Blue Bell Light Ice Cream Cookies 'n Cream 25% fewer calories and 55% less fat than regular ice cream HALF GALLON (1.89L)
Blue Bell No Sugar Added Lowfat Ice Cream Country Vanilla HALF GALLON (1.89L)
Blue Bell No Sugar Added Lowfat Ice Cream Dutch Chocolate HALF GALLON (1.89L)
Blue Bell No Sugar Added Lowfat Ice Cream Strawberries 'n Cream HALF GALLON (1.89L)
Blue Bell Lowfat Yogurt Country Vanilla HALF GALLON (1.89L)
Blue Bell Lowfat Yogurt Strawberry HALF GALLON (1.89L)
Blue Bell Sherbert Lime One Quart Naturally Low Fat
Blue Bell Sherbert Pineapple One Quart Naturally Low Fat
Blue Bell Sherbert Rainbow One Quart Naturally Low Fat
Blue Bell Ice Cream Amaretto Cherry 3 Gallon
Blue Bell Ice Cream Banana Pudding 3 Gallon
Blue Bell Ice Cream Banana Split 3 Gallon
Blue Bell Ice Cream Birthday Cake 3 Gallon
Blue Bell Ice Cream Black Cherry 3 Gallon
Blue Bell Ice Cream Black Walnut 3 Gallon
Blue Bell Ice Cream Blue Monster 3 Gallon
Blue Bell Ice Cream Butter Crunch 3 Gallon
Blue Bell Ice Cream Buttered Pecan 3 Gallon
Blue Bell Ice Cream Cake Batter 3 Gallon
Blue Bell Ice Cream Caramel Turtle Fudge 3 Gallon
Blue Bell Ice Cream Cherry Vanilla 3 Gallon
Blue Bell Ice Cream Chocolate Chip 3 Gallon
Blue Bell Ice Cream Chocolate Chip Cookie Dough 3 Gallon
Blue Bell Ice Cream Chocolate Covered Cherries 3 Gallon
Blue Bell Ice Cream Chocolate Peanut Butter 3 Gallon
Blue Bell Ice Cream Christmas Cookies 3 Gallon
Blue Bell Ice Cream Coffee Toffee Crunch 3 Gallon
Blue Bell Ice Cream Cookies 'n Cream 3 Gallon
Blue Bell Ice Cream Cotton Candy 3 Gallon
Blue Bell Ice Cream Dulce de Leche 3 Gallon
Blue Bell Ice Cream Dutch Chocolate 3 Gallon
Blue Bell Ice Cream French Vanilla 3 Gallon
Blue Bell Ice Cream Fudge Brownie Nut 3 Gallon
Blue Bell Ice Cream Gingerbread House 3 Gallon
Blue Bell Ice Cream Happy Tracks 3 Gallon
Blue Bell Ice Cream Homemade in the Shade 3 Gallon
Blue Bell Ice Cream Homemade Vanilla 3 Gallon
Blue Bell Ice Cream I Heart Chocolate 3 Gallon
Blue Bell Ice Cream Italian Cream Cake 3 Gallon
Blue Bell Ice Cream Krazy Kolors 3 Gallon
Blue Bell Ice Cream Krazy Kookie Dough 3 Gallon
Blue Bell Ice Cream Magic Cookie Bar 3 Gallon
Blue Bell Ice Cream Malt Shoppe 3 Gallon
Blue Bell Ice Cream Maple Walnut 3 Gallon
Blue Bell Ice Cream Milk & Cookies 3 Gallon
Blue Bell Ice Cream Milk Chocolate 3 Gallon
Blue Bell Ice Cream Mint Chocolate Chip 3 Gallon
Blue Bell Ice Cream Mocha Almond Fudge 3 Gallon
Blue Bell Ice Cream Moo-llenium Crunch 3 Gallon
Blue Bell Ice Cream Natural Vanilla Bean 3 Gallon
Blue Bell Ice Cream Peaches & Homemade Vanilla 3 Gallon
Blue Bell Ice Cream Peachy Peach 3 Gallon
Blue Bell Ice Cream Pecan Pralines 'n Cream 3 Gallon
Blue Bell Ice Cream Peppermint Bark 3 Gallon
Blue Bell Ice Cream Pistachio Almond 3 Gallon
Blue Bell Ice Cream Red Velvet Cake 3 Gallon
Blue Bell Ice Cream Rockslide Brownie 3 Gallon
Blue Bell Ice Cream Rocky Mountain Road 3 Gallon
Blue Bell Ice Cream Sea Salt Caramel 3 Gallon
Blue Bell Ice Cream Southern Blackberry Cobbler 3 Gallon
Blue Bell Ice Cream Spiced Pumpkin Pecan 3 Gallon
Blue Bell Ice Cream Strawberries & Homemade Vanilla 3 Gallon
Blue Bell Ice Cream Strawberry Cheesecake 3 Gallon
Blue Bell Ice Cream Triple Caramel 3 Gallon
Blue Bell Ice Cream Triple Chocolate 3 Gallon
Blue Bell Ice Cream White Chocolate Almond 3 Gallon
Blue Bell Frozen Yogurt Country Vanilla 3 Gallon
Blue Bell Frozen Yogurt Strawberry 3 Gallon
Blue Bell Frozen Yogurt Vanilla Bean 3 Gallon
Blue Bell Ice Cream No Sugar Added Buttered Pecan 3 Gallon
Blue Bell Ice Cream No Sugar Added Country Vanilla 3 Gallon
Blue Bell Ice Cream No Sugar Added Dutch Chocolate 3 Gallon
Blue Bell Ice Cream No Sugar Added Strawberries 'n Cream 3 Gallon
Blue Bell Ice Cream Creole Cream Cheese 3 Gallon
Blue Bell Ice Cream Kentucky Delight 3 Gallon
Blue Bell Ice Cream Orange Pineapple 3 Gallon
Blue Bell Ice Cream Purple Homemade Vanilla 3 Gallon
DZ 4 oz. Cookie Cone - Institutional Snack
DZ Country Cone, Vanilla - Single Serve Snack
DZ Fudgy Bar - Single Serve Snack and 12 Pak Fudge Bars
DZ Coconut Bar- Single Serve Snack and 6 Pak Coconut Fruit Bars and 6 Pak Dipped Coconut Fruit Bars
DZ  3 oz. Fiesta Sundae Cup - Institutional Snack Item available for Cinco de Mayo
DZ  Strawberry Banana Bar - Institutional Snack Item;  DZ  Strawberry Shortcake Bar - Institutional Snack Item; DZ Strawberry Fruit Bar - Single Serve Snack; 12 Pak Strawberries & Homemade Vanilla Bars; 6 Pak Dipped Strawberry Fruit Bars; 6 Pak Strawberry Fruit Bars
DZ Lime Fruit Bar - Single Serve Snack; 6 Pak Lime Fruit Bars
DZ Fruiti Bar - Institutional Snack Item; 6 Pak Mixed Berries Fruit Bars
DZ Peach Fruit Bar - Single Serve Snack; 6 Pak Peach Fruit Bars
DZ Banana Fudge Bar- Single Serve Snack; 12 Pak Banana Pops
DZ Chocolate Fudge Bar - Single Serve Snack; DZ Fudge Blast - Single Serve Snack; DZ Fudge Bombstick - Single Serve Snack; 24 Pak Pop 'n Fudge
DZ Cookies 'n Cream Sandwich - Single Serve Snack; DZ Country Cone, Cookies 'n Cream - Single Serve Snack; 3 oz. Cookies 'n Cream Sandwich - Institutional Snack Item; 3 oz. Cookies 'n Cream Sundae Cup - Institutional Snack Item; 12 Pak Cookies 'n Cream Bars
DZ Double Vanilla Sandwich - Single Serve Snack; DZ Ice Cream Sandwich - Single Serve Snack; DZ 3 oz. Vanilla Ice Cream Sandwich - Institutional Snack Item; 24 Pak Mini Sandwiches; 12 Pak Ice Cream Sandwiches
DZ Dream Bar - Single Serve Snack; 12 Pak Dream Bars
DZ Krunch Bar - Single Serve Snack; DZ Mini Krunch Bar - Institutional Snack Item; 12 Pak Butter Crunch Bars; 12 Pak Krunch Bars; 12 Pak No Sugar Added Krunch Bars
DZ Mooo Bars - Single Serve Snack Item; 12 Pak Mooo Bars
DZ Neopolitan Sandwich - Single Serve Snack Item
DZ  Rainbow Freeze Bar - Single Serve Snack Item; DZ  Rainbow Pop Up - Single Serve Snack Item; 24 Pak Mini Rainbows; DZ Mini Rainbow - Institutional Snack Item
DZ 3 oz. Cookie Cone - Single Serve Snack Item; DZ 3.6 oz. Cookie Cone - Single Serve Snack Item; DZ 4 oz. Nutzo Cone _ Single Serve Snack Item; 12 Pak Mini Country Cones, Vanilla; 12 Pak Mini Party Cones
DZ 3 oz. All American Cup - Institutional Snack Item available on/around patriotic holidays
DZ 3 oz. Autumn Twist Cup - Institutional Snack Item available on/around Thanksgiving
DZ 3 oz. Cherry Sundae Cup - Institutional Snack Item available on/around Valentine's Day
DZ 3 oz. Chocolate Sundae Cup - Institutional Snack Item available on/around Halloween
DZ 3 oz. Spring Twist Cup - Institutional Snack Item available on/around Easter
DZ 3 oz. Strawberry Sundae Cup - Institutional Snack Item available on/around Christmas
DZ 3 oz. Citrus Swirl Cup - Institutional Snack Item
DZ 3 oz. Strawberry Frozen Yogurt Cup - Institutional Snack Item
DZ 3 oz. Chocolate Frozen Yogurt Cup - Institutional Snack Item
DZ 3 oz. No Sugar Added Vanilla Cup - Institutional Snack Item
DZ 3 oz. Big Shot - Institutional Snack Item
DZ Blue Raspberry Freeze Bar - Institutional Snack Item; DZ Cherry Freeze Bar - Institutional Snack Item; DZ Grape Freeze Bar - Institutional Snack Item
DZ Chocolate Eclair Bar- Institutional Snack Item
DZ Grizzly Bar - Institutional Snack Item
24 Pak Bullets; 24 Pak Sugar Free Bullets
12 Pak Dutch Chocolate and Homemade Vanilla Cups; 12 Pak Homemade Vanilla Cups; DZ Homemade Vanilla Cups - Single Serve Snack Item
Diet Dr. Pepper, 8 x 12 fl. oz. PET bottle, Bottled under the authority of Dr. Pepper Company, 5301 Legacy Drive, Plano, TX 85024.
A Diet Dr. Pepper labeled product contain regular Dr. Pepper.
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB  This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves.   For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03
The Overpressure Safety Valve are not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit.There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
Natural Creations Glucosamine MSM 90 capsules packaged in 250 cc white plastic containers with 52 bottles per case.
Lot numbers: 4072202, 3073009, 2030110, 1010705. All products with expiration dates.
Natural Creations is recalling Glucosamine MSM dietary supplement due to unlabeled allergen (shellfish).
Worldwide Distribution - US Nationwide in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IA, KS, LA, MA, MI, MN, MS, MO, NE, NH, NY, NC, OH, OK, PA, RI, SD, TN, TX, VA, WA, including Puerto Rico  and the countries of Australia, Bahamas, Canada, Guatemala, and Mexico.
Lifesaver Single Patient Use Manual Resuscitator     Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.
Product Code 5361 -  6 Digit Lot No. 140514 - 4 Digit Lot No. 1420; 6 Digit Lot No. 140616  4 Digit Lot No. 1425, 6 Digit Lot No. 140617  4 Digit Lot No. 1425; 6 Digit Lot No. 140621  4 Digit Lot No. 1425; 6 Digit Lot No. 140806  4 Digit Lot No. 1432;  6 Digit Lot No. 141103  4 Digit Lot No. 1445; 6 Digit Lot 141117 - No. 4 Digit Lot No. 1447; 6 Digit Lot No. 141201- 4 Digit Lot No. 1449; 6 Digit Lot No. 141224 - 4 Digit Lot No. 1452; 6 Digit Lot No. 141227 - 4 Digit Lot No. 1452; 6 Digit Lot No. 150112 - 4 Digit Lot No. 1503; Product Code 5362 - 6 Digit Lot No. 140504 - 4 Digit Lot No. 1419; 6 Digit Lot No. 140515 - 4 Digit Lot No. 1420; 6 Digit Lot No. 140517 - 4 Digit Lot No. 1420; 6 Digit Lot No. 140617 - 4 Digit Lot No. 1425; 6 Digit Lot No. 140621 - 4 Digit Lot 1425; No. 6 Digit Lot No. 140812 - 4 Digit Lot No. 1433;  6 Digit Lot No. 140819 - 4 Digit Lot No. 1434; 6 Digit Lot No. 140823 - 4 Digit Lot No. 1434; 6 Digit Lot No. 140929 - 4 Digit Lot No. 1440; 6 Digit Lot No. 141110 - 4 Digit Lot No. 1446; 6 Digit Lot No. 141115 - 4 Digit Lot No. 1446; 6 Digit Lot No. 141201 - 4 Digit Lot No. 1449; 6 Digit Lot No. 141214 - 4 Digit Lot No.1451; 6 Digit Lot No. 150112  4 Digit Lot No. 1503; Product Code 5364  6 Digit Lot No. 140507 - 4 Digit Lot No. 1419;  6 Digit Lot No. 140508  4 Digit Lot No. 1419; 6 Digit Lot No. 140514 - 4 Digit Lot No. 1420; 6 Digit Lot No. 140608 - 4 Digit Lot No. 1424; 6 Digit Lot No. 140614 - 4 Digit Lot No. 1424; 6 Digit Lot No. 140623 - 4 Digit Lot No. 1426; 6 Digit Lot No. 14628 - 4 Digit Lot 1426 - No. 6 Digit Lot No. 140714 - 4 Digit Lot No. 1429; 6 Digit Lot No. 140719 - 4 Digit Lot No. 1429; 6 Digit Lot No. 14806 - 4 Digit Lot No. 1432; 6 Digit Lot No. 140809  4 Digit Lot No. 1432; Product Code 5466  6 Digit Lot No. 140520 - 4 Digit Lot No. 1421; 6 Digit Lot No. 140923 - 4 Digit Lot No. 1439; 6 Digit Lot No. 140924 - 4 Digit Lot No. 1439; Product Code 45362 - 6 Digit Lot No. 140317 - 4 Digit Lot No. 1412; 6 Digit Lot No. 140630 - 4 Digit Lot No. 1427; 6 Digit Lot No. 141013 - 4
The intake port may be blocked which can cause the bag to fail to fill.
Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar, Sweden, Singapore,Thailand, Turkey, Taiwan, Venezuela and South Africa.
ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537    Intended for Meniscal Repair.
All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019
Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting.
CT, DC, DE, KY, MA, MD, ME, NH, NJ, NY, OH, PA, RI, VA, WV
Raw Macadamia Nuts, packaged in 8 oz. plastic cup, packaged under the Aurora and private labels as follows:Belmont Market, Citarella, Ernest & Klein, Gourmet Garage, Harvest Co  Op Market, Le District, Lees, Palmers Market, Walter Stewart, Whole Food Market and Wild By Nature.   Refer to Best By Date
Brand/Product Type    UPC                       Best If Used By Date Range Aurora Macadamia  UPC: 655852 - 00083 Best By Date: 12/10/2015 - 12/30/15;  Belmont Market  Macadamia  UPC: 655852 - 00083   Best By Date:12/12/2015 - 12/26/2015;  Citarella Brand Products Macadamia  UPC:150209 - 12050 Best By Date: 12/30/2015;  Ernest Klein Macadamia  UPC: 655852 - 00083 Best By Date:12/26/2015 - 1/8/2016;  Gourmet Garage Premimum Whole Macadamia Nut  UPC: 790845 - 05025 Best Buy Date: 12/17/2015 - 12/30/2015;  Harvest Co - Op Macadamia  UPC: 655852 - 00083 Best By Date: 1/9/2016;  Le District Macadamia  UPC:  655852 - 00083 Best By Date: 12/19/2015  Lees Market  Macadamia  UPC: 655852 - 00083 Best By Date:12/12/2015;  Palmers Market Macadamia  UPC: 655852 - 00083 Best By Date: 1/8/2016;  Wild By Nature Macadamia  UPC :655852 - 70083 BestBy Date:12/10/2015 - 12/30/2015;  Walter Stewart Market  Macadamia  UPC:655852 - 00083 Best By Date:12/11/2015  Whole Foods Market Premimum Whole Macadamia Nut   UPC: 655852 - 00083 Best By Date: 12/10/2015 - 1/6/2015
Blood product, which was not quarantined after receiving post donation information concerning an illness following donation, was distributed.
Blood product, with a low platelet count, was distributed.
Texas; Wisconsin; California; Tennessee; Illinois
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
Worldwide Distribution - US (nationwide) including PR and to the states of: AZ, AK, AL, AR, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, MO, ME, MT, NC, ND, NE, NH, NJ, NY, NM, OH,OK,OR,  PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY., and to the countries of : China, Korea, Denmark, Mexico, New Zealand, India and Colombia.
LapSac  Surgical Tissue Pouch.   The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.
123,184 devices were distributed in commerce
Includes Information not stated in the intended use.
Fruit Juice Candy Bonbons de Jus de Fruits, Net Wt 8 oz (227g), UPC Code 6 923648 832113, Manufacturer. Jin Shun FA Food Co., Ltd. 147 community shops Southwest District Luoshan Street Jinjiang of Fujian, Sole Agent of U.S.A.: Fine Land Corp. 376 Vernon Ave, Brooklyn, NY 11206, Sole Agent of Canada: PT Trading Enterprises Ltd. 928 Kingsway, Vancouver, B.C. V5V 3C4.  Product of P.R.C.
The Florida Dept of Agriculture sample tested positive for lead at concentration of 0.226 ppm (ug/g).
Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, (People's Republic of) China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, (Republic of) Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.
VersaTREK (tm) Instrument Series 240 REF 6240, Manufactured for Remel Inc.   The VersaTREK (tm) System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
Use of the recalled product may result in false positive reports.
VersaTREK (tm) Instrument Series 528 REF 6528, Manufactured for Remel Inc.   The VersaTREK (tm) System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
Worldwide Distribution: US (nationwide) and country of Guatemala.
Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves:  ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-3479-1; LAPAROSCOPY TRAY, REF 89-3605; KNEE/ARTHROSCOPY TRAY, REF 89-3606; SHOULDER/ARTHROSCOPY TRAY, REF 89-3607; LOWER EXTREMITY TRAY, REF 89-3609; BASIC TRAY, REF 89-3610; HAND TRAY, REF 89-3611; NEURO SPINE TRAY, REF 89-3808; NEURO CRANIOTOMY TRAY, REF 89-3809; BASIC SET UP TRAY, REF 89-4137; BASIC PACK, REF 89-4798; SJCHS EXTREMITY TRAY, REF 89-4832; TOTAL KNEE TRAY PGYBK, REF 89-4902; ORTHO SPINE TRAY, REF 89-4935; MAJOR EXTREMITY PACK, REF 89-5057; STANDARD LAP CHOLE PACK, REF 89-5059; UROLOGY CYSTO PACK, REF 89-5246; LAPAROSCOPIC CHOLE PACK, REF 89-5259; FACELIFT & EYELID PACK, REF 89-5609; FACELIFT PACK, REF 89-5611; LAPAROSCOPY PACK, REF 89-5978; HYSTEREOSCOPY TRAY, REF 89-5979; CABG PACK PGYBK A & B, REF 89-5985; OPHTHALMOLOGY PACK PGYBK, REF 89-6263; VASCULAR DRAPE PACK, REF 89-6264; HEART PACK PGYBK, REF 89-6341; SHOULDER PACK, REF 89-6354; MINOR CUSTOM PACK, REF 89-6374; CATARACT PACK PGYBK, REF 89-6377; SURGI-START KIT, REF 89-6378; PACEMAKER PACK, REF 89-6396; GENERAL LAPAROSCOPIC PACK, REF 89-6409; OPEN HEART PROCEDURE PACK TOTAL, REF 89-6508; TOTAL HIP PACK A&B, REF 89-6798; KNEE PACK A&B, REF 89-6799; MAIN OH SUPPLY A&B PACK, REF 89-6855; CRANIOTOMY PACK, REF 89-7017; PACEMAKER PACK, REF 89-7018; GYN MINOR PACK, REF 89-7020; ENT MAJOR PACK, REF 89-7022; GENERAL MAJOR PACK, REF 89-7025; GENERAL MINOR PACK, REF 89-7026; PV PACK, REF 89-7028; GENERAL LAPAROSCOPY PACK, REF 89-7031; CRANIOTOMY PACK, REF 89-7058; LAPAROSCOPY PACK-LF, REF 89-7061; HEAD & NECK PACK, REF 89-7062;  VAGINAL HYSTERECTOMY PACK-LF, REF 89-7067; C-SECTION PACK-LF, REF 89-7068; GYN LAPAROSCOPY PACK, REF 89-7075; OPEN HEART PACK, REF 89-7076;  C-SECTION PACK, REF 89-7105;  TOTAL KNEE PACK, REF 89-7114; ARTHROSCOPY ALL PACK, REF 89-7115; GENERIC ORTHO PAC
Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes
EVAC 70 XTRA with Integrated Cable REF EICA5872-01   Product Usage:  PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction by reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.
Potential component failure causing device inoperability
PROcise XP Wand with Integrated Cable REF EICA8872-01   Product Usage:  PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction by reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.
Potential component failure resulting in inoperability
U.S. distribution to the following; CA, AZ, NM, and NV.  No foreign consignees.
Frozen Tuna Ground Indonesia/Wild Caught      Label on outer shipping cardboard box:  Frozen Tuna Fillet   Restaurant Supply Only  Packed For: Mutual Trading Co., Inc.  LA, CA 90013  Product of Indonesia    Product is ROP.  Packages are packed in a white cardboard box and then in a larger shipping cardboard box.
Osamu Corporation is recalling frozen ground tuna 22lbs/case due to potential Salmonella contamination.
Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309  Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
Mediterranean Seasoned Wild Alaska Salmon, brand name Orca Bay, IVP frozen packages, ready to cook product. Products are keta salmon fillets with a brown spice rub. Each fillet is individually vacuum-packed in a clear plastic film and ranges from 1-2 lbs.    UPC 2 08617 60XXX X  (UPC is labeled at retail stores).  The last 4 digits of the UPC is different on each retail unit because these items are random weight and priced at the store level. The last 4 digits correspond to the price of that specific fillet based on its weight.
90730-MR102388. Best By 06 MAY 2016.   90730 = item number; MR102388 = production number.
Mediterranean Seasoned Wild Alaska Salmon is recalled due to undeclared wheat and soy (soy sauce).
Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
Blood products, which did not meet acceptable product specifications, were distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood product, which was not quarantined subsequent to receiving information due to a donor vCJD risk, was distributed.
Worldwide Distribution -- US, including the states of CA, IL, MN, and PA; and, the countries of Australia, Bahrain, Belgium, Canada, China, Cypress, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Kuwait, Lebanon, Malaysia, Maldives, Oman, Schweiz, South Africa, Spain, Sweden, Switzerland, Netherlands, Turkey, United Arab Emirates, and United Kingdom.
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset   Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
US: AL, AZ, C, GA, ID, IL, IN, LA, KS, MD, MI, MN, NS,NO, NH, NY, NC, OH, OK, PA,TN, TX, UT, VA, CO, FL.   OUS: Canada
SNOBIZ CHEESECAKE SHAVE ICE FLAVOR, 10 pouches/carton; 8 cartons/case (80 pouches total per case), 104 gram per pouch, metallized pouch.
This recall has been initiated due to (mis-labeling) of an undeclared milk allergen on the Cheesecake Shave Ice pouch.
Jivara Lactee Milk Chocolate Valrhona; 40% Ingredients: Cocoa Butter, whole powdered milk, sugar, cocoa beans, brown sugar, natural vanilla extract, soya lecithin, malt extract, Natural Vanilla Flavor.  Contains: Soy,. May contain trace amounts of dairy, eggs, nuts and gluten as it produced on the same machinery.  UPC 2503044025508    Whole Foods Market, Emeryville, CA 95408
One retail location incorrectly labeled Jivara Lactee Milk Chocolate Valrhona cut and wrap pieces without hazelnuts declared on the product label.
Blood product, collected from a donor who received a tattoo in a non-regulated state, was distributed.
Vitamin Cottage Natural Food Markets, Inc.
Nationwide.  No foreign or military/VA/govt consignees.
Natural Grocers Raw Macadamia Nuts, Net Wt. 10 oz. package, Sealed plastic bag.
Vitamin Cottage Natural Food Markets Inc. is recalling various lots of Natural Grocers brand Macadamia nuts because the product has the potential to be contaminated with Salmonella.
Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.
Fortex'' Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
Artis zee/ zeego systems;    Product Usage:  Usage:  Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.  .
There exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, resulting in a collision. No injuries reported.
Worldwide Distribution-Distributed in the states of Florida, New Mexico and New York and the countries of Australia, Belgium, Chile, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, Guatemala, Israel, Italy, Japan, Kazakhstan, Latvia, Netherlands, Portugal, Romania, Russian Federation, Slovakia, and Spain.
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD.   For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.
IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products label.
Michigan, Massachusetts, New York and Canada.
Vietnamese LP Cashew Kernels, 50 lbs. bulk cartons, HONG DUC COMPANY LIMITED, FDA No. 16153193186  --- The imported cashews are shelled and raw, and were distributed in bulk cartons/cases weighing 50 lbs. ---  NOTE: The shelf life is 12 months from pack date which is November 3, 2014.
The lot of imported cashews was found to be contaminated with Salmonella based on FDA sampling and analysis.
Worldwide Distribution -- US (nationwide) and Canada.
Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18'' (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers of the small intestine of healthy sheep, or from the serosal layers of the small intestine of healthy cattle. Fast absorbing surgical gut sutures are sterile and elecit only a slight to minimal tissue reaction during absorption.
Product Code: 1915G (box label); 1915 (Tyvek/Foil label) Product Lot #'s JC6395, JC6417, JCK328, JCK329, JCK384, JCK716, JCM669, JCM757, JCZ987, JC5020, JC6710, JCM535, JCK330, JCK460, JCM668, JC5629 and JCM475.
Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.
Worldwide Distribution - US (nationwide) and Internationally to US Argentina, Australia, Bolivia, Brazil, Chile, China, Colombia, Hong Kong, India, Italy, Japan, Republic of Korea, Malaysia, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
SERFAS 90 degree Energy Probe, Part Number 279-350-101;   SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are used for resection, ablation and coagulation of soft tissue, as well as the hemostasis of blood vessels.
Part number 279-350-101; All non expired product; lot numbers 13128AE2 through 14337AE2.
Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.
Distributed Nationwide including Puerto Rico.
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73.   Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73.    Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22.    Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
Eating Right Black Bean Soup; 1.3 oz paper container. Dried soup to which consumer adds hot water. USPC: 79893-80026; Ingredients: Ingredients: Black Beans*, Vegetables* (Tomato, Potato, Corn, Peppers, Garlic), Natural Flavor (Yeast Extract, Maltodextrin, Sunflower Oil, Silicon Dioxide, Natural Flavor), Spice, Salt, Oregano.* *Dried    Cases of Eating Right Spicy Thai Soup (12 x 1.3 oz. containers per case), USPC:  79893-80030.   Ingredients: Please note that Spicy Thai Noodle has noodles in a cup and then a sealed flavor packet inside the cup which consumers must open and pour out.  Ingredients: Noodles* (Durum Semolina Wheat Flour, Niacin, Ferrous Sulfate (Iron), Thiamine Mononitrate, Riboflavin, Folic Acid), Vegetables* (White Onion, Green Onion, Garlic, Bell Pepper, Shallots), Natural Flavors (Yeast Extract, Tapioca Maltodextrin, Chicken Fat, Dextrose, Salt, Potassium Chloride, Anchovy (Fish), Lactic Acid, Glycerine, Silicon Dioxide), Dried Cane Syrup, Soy Sauce* (Soybeans, Wheat), Sesame (Seeds and Oil), Spices (Including Mild Chilies, Lemongrass, Ginger, Black Pepper, Cumin, Cayenne, Turmeric), Lime*, Cilantro*, Basil*, Citric Acid, Guar and Xanthan Gum, Tamarind*, Extract of Paprika. *Dried      Eating Right is a SafeTway brand name and is only sold in Safeway stores and their subsidiaries of Vons.    Mfg for Safeway by San Francisco Spice Co., So. San Francisco, CA.
Best Before 01/21/16 for individual units of Eating Right Black Bean Soup and cases of Eating Right Spicy Thaie Noodle Soup mix.
Some containers or Eating Right Black Bean Coup may contain Eating Right Spicy Thai Noodle inside.
US Distribution to the states of : AZ, CA, ID, MO, and NH.
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154.   The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.
Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578-035-05, b) 5 oz. Jar, NDC 10578-035-04, Manufactured by Indiana Botanic Gardens, Hobart, IN 46342
Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY  NDC 32909-727-01
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Nationwide Distribution including Guam, DC, and Puerto Rico.     OUS: VIET NAM, VENEZUELA, UZBEKISTAN, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TRINIDAD & TOBAGO, THAILAND, TAIWAN EL SALVADOR, SRILANKA, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL PHILIPPINES, PERU, PARAGUAY, PANAMA, PAKISTAN, NEW ZEALAND, NICARAGUA, NEPAL, MYANMAR, MOROCCO, MEXICO, MARTINIQUE, MALAYSIA, LEBANON, KUWAIT, REPUBLIC OF KOREA, KAZAKHSTAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HON GONG, GERMANY, FRANCE, FINLAND, ETHIOPIA, EGYPT, ECUADOR, DOMINICAN REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE , CAYMAN ISLAND , CANADA, CAMBODIA, BRUNEI DARUSSALAM, BRAZIL, BOLIVIA, BHUTAN, BANGLADESH, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.
GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.
GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.
Surface Applicator Set with Leipzig-style Cone.   Brachytherapy applicator set.
Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06.     The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmation of the dose could result in an administration of dose  greater than intended.
Distribution was made to WV, VA, OH, and NC.
Deskins Candies, Chocolate No Bakes, Net Wt. 16-oz., packaged in 1 lb. plastic containers containing 8-10 cookies / 12 containers per case.  Deskins Wholesale, Bluefield, WV.
The recalled product contains undeclared peanut butter.
Distributed in Arizona, California, Colorado, Indiana, Iowa, Oregon, Pennsylvania, Tennessee, Texas, and Washington
Lemon Flavored Electrolyte bottled water, sold under brand HyVee, Raleys' Purely Made, Refreshe, and Simple Truth.  Each bottle is 1 Liter (33.8 Fl. oz.).   HyVee brand has the UPC     0 75450 12722 5;  Raley's brand has the UPC    0 46567 02873 6;  Refreshe brand has the UPC 0 21130 24207 8;  Simple Truth has the UPC     0 11110 79101 6;
Lemon Flavored Electrolyte water is recalled due to high total coliform testing results.
Mixed Berry Flavored Electrolyte bottled Water, sold under brand HyVee, Raleys' Purely Made, and Refreshe.  Each bottle is 1 Liter (33.8 Fl. oz.).   HyVee brand has the UPC  0 75450 12723 2;  Raley's brand has the UPC 0 46567 02874 3;  Refreshe has the UCP        0 21130 24209 2;
Mixed Berry Flavored Electrolyte Water is recalled due to high total coliform testing results.
Lime Flavored Electrolyte bottled Water, sold under brand Refreshe.  Each bottle is 1 Liter (33.8 Fl. oz.).  This brand has the UPC 0 21130-24208 5.
Lime Flavored Electrolyte bottled Water is recalled due to high total coliform testing results.
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc., Mississauga, Ontario L9N7K9 Canada, NDC 52544-0949-28
Lot #s: KPPY, Exp 06/15; NBXD, NBXF, Exp 10/16; NBXG, Exp 09/15; NKZS, Exp 11/15; NMPT, NNXB, NNWG, Exp 01/16; NMPV, NVWN, NVWP, Exp 02/16; NMTP, NNXC, Exp 03/16; NMWC, NNXH, Exp 04/16; PFHT, PFHW, PFHX, Exp 06/16; PKHH, PKHN, PKHS, PKHT, PPGG, PPGH, PVSZ, Exp 08/16; PYDX, Exp 09/16.
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany.
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Catalo Number PR0-6F-11-038, Lot Number H767887
Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the labeling of the Merit Prelude Sheath Introducer and the actual configuration of the device in the packaging. Some of these introducer sheaths were packaged with a 0.035'' dilator, rather than the labeled 0.038''.This affects one lot, H767887, of catalog number PR0-6F-11-038.
Worldwide distribution: US (Nationwide) and country of: Canada.
Volcano PV .035 Catheter: Part number: 88901;    Product Usage:  The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Product number 88901; lot number 50002518
162 total devices (included both products)
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
Prestige Plus 185cm J-Tip: Part number: 9185J;    Product Usage:  The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Product number 9185J; lot number 50004551/005-060, serial numbers 005-060.