Recalling Firm
The Hain Celestial Group- Worldwide Headquarters
Sunshine Burger & Specialty Food Company, LLC
Vitamin Cottage Natural Food Markets, Inc.
Zimmer Trabecular Metal Technology, Inc.
Roswell Park Cancer Institute Corporation. Div. of Pathology

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Distributed in the following states: AL, CA, FL, GA, IL, MA, MN, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI; OUS: Australia, Austria, Belgium, China, Ecuador, Finland, France, Germany, Italy, Japan, Mexico, Netherlands, slovenia, South Africa, Sweden, Switzerland, United Kingdom
US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD,MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV)
Worldwide Distribution - US Nationwide in the states of CA, CT, FL, IA, ID, IL, MT, NC, NY, TX, WA and in the countries of: Argentina, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, Denmark, El Salvador, France, Germany, Hungary, India, Italy, Japan, Netherlands, Nigeria, Portugal, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom.
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
distributed in Alaska, Oregon, and Washington
nationwide via internet sales and in NY via 6 retail stores.
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico.
US Distribution to the states of OH and PA.
Nationwide in US and worldwide to Japan, Australia, AE, Singapore
Maryland and Virginia to three Consignees
Distributed to stores in Colorado, Arizona, New Mexico, Texas, Oklahoma, Missouri, Kansas, Nebraska, Utah, Wyoming, Montana, Idaho, Oregon, Washington, Nevada, Arkasas. No distribution to U.S. Defense Supply, VA, or foreign countries.
Distributed in the states of OK, KS, FL, and AL.
distributed in California, Oregon, and Washington
US Distribution to the states of : AZ, CA, CT, FL, GA, ID, IL, KY, MD, MO, NV, NY, OH, OK, OR, TX, UT and WI.
Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.
US Nationwide Distribution in the states of TN, IA, AZ, NE, SD, NY, and OK.
Domestic: Two customers- National City/Twin City 130 Hardman Ave S South St. Paul, MN 55075 EPI Breads 4710 W Ledbetter Dr. Dallas, TX 75236 Foreign: None
Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WA.
Worldwide Distribution - USA ( nationwide ) and to the countries of: Canada, European Union, Singapore and Australia.
AK, AZ, CA, CT, FL, IA, IL, MA, MD, ME, MI, MO, MS, MT, ND, NH, NJ, NY, OH, SC, UT, VA, VT, WI
Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom.
Worldwide Distribution - USA (nationwide) Distribution including PR, GU and DC., and to the countries of: ALBANIA. ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DLVOIRE, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY. GHANA, GREECE, GUADELOUPE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAHHSTAN,KENYA,REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMA N,PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SIERRA LEONE, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UGANDA , UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM and ZAMBIA.
Worldwide distribution: US distribution in TN and country of: Austria.
Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.

Product Description
Red Blood Cells Leukocytes Reduced Irradiated
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring System, Wireless SpO2 Module used with the Precess MRI Compatible Patient Monitoring System, Philips Basic Triggering Set, Philips Monitoring Sensor Set, Philips Battery Set
Mini Naan Eight (8) nann packaged in coated paper printed board and transparent wrap with a net weight of 12.6 oz (360 g) per package and old under the US Foods brand. Product is labeled with instructions to keep frozen until use. Eight (8) packages per case.
Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist.
B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.
Guava filled pastry (''Pastelillo de Guayaba'' in Spanish) 2.5 oz and 10 oz.
Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.
Ground Cumin, sold under Aunt Patty's brand, packed in 1lb. pack, 5 lb. pack, 25 lb. pack, and 50 lb. pack. Product is labeled in part, ''***Handled in a facility that processes and/or repacks peanuts, soy, wheat, tree nuts, and dairy products.***'' Item #12650 is for 1 lb. Item #12648 is for 5 lb. Item #12651 is for 25 lb. Item #12649 is for 50 lb.
Barley & Lentil Soup Spice Mix, sold under Aunt Patty's brand, packaged in 25 lb. pack. Item # 18058. Product is labeled in part, ''***Handled in a facility that processes and/or repacks peanuts, soy, wheat, tree nuts, and dairy products.***''
Mild Chili Powder, Salt-Free, sold under brand Aunt Patty's brand, packaged in 25 lb. pack. Item #14835. Product is labeled in part, ''***Handled in a facility that processes and/or repacks peanuts, soy, wheat, tree nuts, and dairy products.***''
Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
HEB Bean & Cheese Dip 9 oz. UPC: 041220804016
HyVee Taco Dinner Kit 12 hard shells, taco sauce & seasoning mix; Net Wt. 9.75 oz. (276 g); UPC:075450018073; DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY WEST DES MOINES, IA 50266
Laura Lynn Taco Dinner Kit Kit Includes: 12 Taco Shells,Seasoning Mix Salsa; Net Wt. 9.75 oz. (276 g); UPC:086854045923; DISTRIBUTED BY INGLES MARKETS, INC. ASHEVILLE, NC 28816
Parade Taco Dinner Kit Includes Shells, Seasoning and Sauce Net Wt. 9.75 oz. (276 g); UPC:050700091518; DISTRIBUTED BY FEDERATED GROUP, INC. 3025 W. SALT CREEK LN. ARLINGTON HEIGHTS, IL 60005
HyVee Taco Sauce Medium Net Wt. 16 oz. (454 g); UPC:075450018196; DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY WEST DES MOINES, IA 50266
HyVee Taco Sauce Mild Net Wt. 16 oz. (454 g); UPC:075450018219; DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY WEST DES MOINES, IA 50266
HyVee Enchilada Sauce Mild Net Wt. 15 oz. (425 g); UPC:075450018097; DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY WEST DES MOINES, IA 50266
Brookshire's red Enchilada Sauce Net Wt. 15 oz. (1 LB) 425g; UPC:092825097488; DISTRIBUTED BY: BROOKSHIRE GROCERY COMPANY P.O. BOX 1411,TYLER, TX 75710-1411
Roundy's original enchilada sauce Net Wt. 15 oz. (425 g); UPC:011150083492; DISTRIBUTED BY: ROUNDY'S SUPERMARKETS, INC. MILWAUKEE, WI 53201-0473
Ricos Thick 'N Chunky Salsa Net Wt. 132 oz. (3.74 Kg); UPC:079426650670; RICOS PRODUCTS CO., INC. 830 S PRESA ST SAN ANTONIO, TEXAS 78210
Roundy's Salsa Verde Salsa Net Wt. 16 oz. (1 LB) 454 g; UPC:011150083645; DISTRIBUTED BY ROUNDY'S SUPERMARKETS, INC. MILWAUKEE, WI 53201-0473
Taj ETHNIC GOURMET BOMBAY CURRY Simmer Sauce, NET WT 16.0 OZ. (454.0g), UPC 7 18687 30010 7
Taj ETHNIC GOURMET CALCUTTA MASALA Simmer Sauce, NET WT 16.0 OZ. (454.0g), UPC 7 18687 30011 4
Taj ETHNIC GOURMET PUNJAB SAAG Spinach Sauce, NET WT 16.0 OZ. (454.0g), UPC 7 18687 30013 8
Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.
Reo Country Style Chili Seasoning NET WT 2 OZS (67G) Reo Spice & Seasoning, Inc. Huntsville, TX 77320 (936)294-0222; Reo Country Style Chili Seasoning NET WT 4 OZS(113G) Reo Spice & Seasoning, Inc. Huntsville, TX 77320 (936)294-0222; Reo Country Style Chili Seasoning NET WEIGHT ONE POUND Reo Spice & Seasoning, Inc. Huntsville, TX 77320 (936) 294-0222
Ground Cumin Net Weight 5 LBS (2.27KG) Bryan, Texas 77802 Distributed by: Ruffino Meats Food Service (979)776-5685
Reo Bear Creek Kitchen Texas Chili Blend Net WT 25 lbs Reo Spice & Seasoning, Inc. Huntsville, TX 77320 (936)294-0222
Vitek's BBQ Seasoning Net Weight 25 LBS Manufactured By: Reo Spice & Seasoning, Inc. Huntsville, TX 77320 936-294-0222
Reo Ranch House Sizzling Steak Beef Jerky Seasoning Total Net Wt. 7.74 LBS Reo Spice & Seasoning, INC. Huntsville, TX 77320 (936)294-0222
Bon Ton Market BBQ Seasoning Net Wt 12 OZS (340 GRAMS) Manufactured for: Bon Ton Market Uhland, TX 78640-4909 (512)396-3810
Reo Texas Burger Taco Meat Mix NET WT. 40LBS Reo Spice & Seasoning, Inc. Huntsville, TX 77320
Jmad's South Texas BBQ Seasonall net Wt 10 OZS (284G) Distributed by: Jmad's Seasonings Corpus Christi, TX 78414 (361)561-4111
Jmad's Brisket Rub Net Wt 10 ozs (284g) Distributed by: Jmad's Seasonings Corpus Christi, TX 78414 (361)561-4111
cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
ALOHA VANILLA PREMIUM PROTEIN is a powder and product is packed as the following: 1) Tin: UPC 641061842606, 2) Pouch: UPC 641061842644 and 3) Protein Tower 14 pack: UPC 640864820729. Formulated, Quality Tested & Exclusively Sold by ALOHA, Inc. NY, NY 10011 +1 888.444.3898
ALOHA CHOCOLATE PREMIUM PROTEIN is a powder and , product is packed as the following: 1) Tin: UPC 641061842613, 2) Pouch: UPC 641061842651 and 3) Protein Tower 14 pack: UPC 640864820743. Formulated, Quality Tested & Exclusively Sold by ALOHA, Inc. NY, NY 10011 +1 888.444.3898
ALOHA VANILLA AND CHOCOLATE PREMIUM PROTEIN powders are distributed under the following labels: 1) ALOHA PREMIUM PROTEIN FREE TRIAL, 2) ALOHA PREMIUM PROTEIN 4 Pack, 3) ALOHA DAILY GOOD AND PREMIUM PROTEIN FREE TRIAL, 4) ALOHA SUPERFOOD SMOOTHIE KIT FREE TRIAL, 5) ALOHA SUPERFOOD SMOOTHIE KIT, 6) ALOHA THE FOUNDATION AND PREMIUM PROTEIN FREE TRIAL, 6) ALOHA DISCOVERY KIT and the 7) ALOHA URBAN OUTFITTERS SUPERFOOD SMOOTHIE KIT. Formulated, Quality Tested & Exclusively Sold by ALOHA, Inc. NY, NY 10011 +1 888.444.3898
ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Information: (For Information Only) The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.
GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system
GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.
Red Blood Cells (Apheresis) Leukocytes Reduced
Frozen vegetable-based burgers RETAIL - DOMESTIC: Organic Sunshine Burgers Gluten Free Soy Free Vegan Barbecue 3 Organic Veggie Burgers Keep Frozen Net WT: 8 OZ. Best Before: 5/4/16; 6/11/2016; 8/13/16; CANADIAN: Organic Sunshine Burgers Barbecue 3 Organic Veggie Burgers Galettes Veggie biologiques Keep Frozen/Garder Congale 3-75 g Burgers/galettes 227 g Best Before/meilleur avant: 16/05/2016
Frozen vegetable-based burgers RETAIL - DOMESTIC: Organic Sunshine Burgers Gluten Free Soy Free Vegan South West 3 Organic Veggie Burgers Keep Frozen Net WT: 8 OZ. Use By: 7/13/16; 7/21/16; 7/28/16; 8/4/16; 8/11/16; FOOD SERVICE: Sunshine Southwestern Style Veggie Burgers 24 Veggie Burgers Net WT: 6 lbs. Item #001113 Use by: 7/13/16; 8/11/16
Organic Sunshine Burgers Gluten Free Soy Free Vegan Loco Chipotle 2 Organic Veggie Burgers Keep Frozen Net WT: 8 OZ. Use By: 8/12/16
Walnuts Halves & Pieces Net Weight 16-oz 454.0 Grams UPC: 0078264065165 Hines Nut Company Dallas, Texas 75201; Walnuts Halves & Pieces Net Weight 12-oz 340.5 Grams UPC: 0078264065127 Hines Nut Company Dallas, Texas 75201; Harris Teeter Farmers Market Walnut Meats Net Weight 10 OZ. (284g) UPC: 072036881144
Organic Sacha Inchi Powder, 8oz. white poly bags, UPC 803813-28444 1. Organic Sacha Inchi Powder, bulk.
1lb mungbean sprouts 15 box (20 bags a box) a week. 10lb mungbean sprouts 30 bag a week. These products are labeled as produced by Henrys Farm Inc
1lb soybean sprouts 30 box (20 bags a box) a week.10lb soybean sprouts 60 bags a week. These products are labeled as produced by Henrys Farm Inc
farm to table meals : Lentil and Barley. This is a dried soup/chili mix which contains lentils and barley in a large zip lock plastic bag along with a small zip lock bag of a chili spice packet. The spice packet contains the recalled cumin. Each plastic zip lock bag has a label affixed to it. The outer label is yellow/orange and black and has a tomato drawing on it. Net. WT. 16 oz.
Whole Foods Market ''Chocolate Cake for Two'' UPC code: 246357004999 Net Wt. 11 oz (0.69lb) in a clear plastic ''clam shell'' container. PLU#46357
Price Rite Ground Cumin, Net Wt. 3 oz, UPC 041190761135
Cremosa Ground Cumin, Net Wt. 1 LB (16 oz.), Dist. By Cremosa Food Company, LLC, 5 Park Drive, Melville, NY 11747
E & S Ground Cumin, Net Wt. 1 LB (16 oz.), E & S Foods, Inc., Whippany, NJ 07981, UPC 000000130059
Breyers No Sugar Added Salted Caramel Swirl 1.5-quart (1.41L) packaged in paperboard tubs Unilever, Englewood Cliffs, NJ 07632 USA Unit UPC: 7756738393. Product sold as 1.5-quart (1.41L) paperboard tubs, delivered to retailers in shrink wrap. Case UPC: 10077567383935
Natural Grocers brand Organic Garlic Powder. Natural Grocers brand Organic Garlic Powder. Packaged in Zip-Lock-type plastic bags, labeled by random weight, average 0.28 lb. per package, distributed in 25 lb. cases. Packed by Vitamin Cottage Natural Grocers, Inc., Lakewood, CO.
Assorted Milk Chocolate Royal Icing Pops sold as Assorted Character Icing Pops, Christmas Icing Pops, and Triple Heart Icing Pops, 24 pops per box. The Milk Chocolate Icing Pops are made to order and sold in unmarked bulk boxes. Each Milk Chocolate Icing Pop is individually wrapped for retail sale in 2 oz. clear cellophane with a curl ribbon closure.
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.
UNCLE BEN'S(R) Ready Rice(R) ROASTED CHICKEN FLAVORED with Carrots and Herbs, Net Wt 8.8 oz (250 g),
UNCLE BEN'S(R) Ready Rice(R) BUTTER & GARLIC FLAVORED, Net Wt 8.8 oz (250 g),
UNCLE BEN'S(R) Ready Rice(R) NEW ORLEANS STYLE RED BEANS & RICE, with a blend of smokey, savory seasonings, Net Wt 8.5 oz (240 g),
UNCLE BEN'S(R) Ready Rice(R) BEEF FLAVOR with carrots and herbs, Net Wt 8.5 oz (240 g),
UNCLE BEN'S(R) Ready Rice(R) ORIGINAL, ENRICHED LONG GRAIN WHITE RICE, Net Wt 8.8 oz (250 g),
Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification.
Organic Chocolate Hazelnut Butter with Fair Trade 65% Dark Chocolate, Item no. N270. Product is sold under Hummingbird brand, packaged in 1 lb. (454 gram) glass jar with white metal lid. The UPC is 6-96859-11035-1.
Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
HAZELNUTS (FILBERTS), varying weights up to 16 oz., Item Code 228119 XXXXXX --- PACKAGED BY FAIRWAY MARKET, 2284 12TH AVENUE, NEW YORK, NY 10027 --- The product is packaged in clear, plastic cello bags of varying weights, each weighing less than one pound. Item Code 228119 XXXXXX (last six digits vary due to weight and price).
Cocola Macaroons; Each box contains 5 flavors (3 ct each): Mango Passion, Raspberry, Pistachio, Coffee, and Chocolate. Net wt. 7 oz. ; UPC 091037037985. Ingredient: Fresh Egg White, Mango Puree, Passion Fruit Puree, Granulated sugar, powdered sugar, Almond Flour,Butter N&A color, coffee extract, sour cream, cream, cacao nibs, dark chocolate. Contains Eggs, Dairy, Nuts Cocola, 2810 Bay Rd., Redwood City, CA 94063
8 in. sundried tomato flavored tortilla wraps, packaged in re-sealable polypropylene bags, 10 wraps per bag. Sold under the El Popocatepetl brand name.
8 in. spinach pesto flavored tortilla wraps, packaged in re-sealable polypropylene bags, 10 wraps per bag. Sold under the El Popocatepetl brand name.
8 in. chipotle flavored tortilla wraps, packaged in re-sealable polypropylene bags, 10 wraps per bag. Sold under the El Popocatepetl brand name.
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).
Flower Orthopedics Small and Medium Implants Set; Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm , Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm ; Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm; the locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit; a reusable, non-sterile flow control cable; a single use, disposable, sterile Wand. The Coblator II is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
Vital Wheat Gluten Agridient, 50 lb. paper sack
Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75'') within a secondary corrugated shipper (16 x 11.02 x 5.12'' inner dimensions). The device is indicated for assisted expression of milk using manual suction.
Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3'') within a secondary corrugated shipper (20.75 x 15.50 x 8.5'' inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.
Alaris PC units, Model No. 8015. Infusion pump.
Stonewall Kitchen Buffalo Wing Sauce Net Wt. 17.5 oz. glass jar UPC 711381-31395 4 Item # 251805,
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.
da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.
da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.
AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E or 22 cu ft cylinder, NDC: 55037-302-09; B) 40 cu ft cylinder, NDC: 55037-302-10; C) 200 cu ft cylinder, NDC: 55037-302-15; D) 220 cu ft cylinder, NDC: 55037-302-16; E) 300 cu ft cylinder, NDC: 55037-302-18, 55037-302-19, 55037-302-20.
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Platelets Pheresis Leukocytes Reduced Irradiated
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03
5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04

Code Info
Batteries with date codes 2808 or earlier.
Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: Lot 6022274, Expiry 2015-04; Lot 6024628, Expiry 2015-08; Lot 6030581, Expiry 2016-07
Lot code for 1 lb. pack: MG0074013; Lot codes for 5 lb. pack: MG0076070, MG0078195, AND MG0074282; Lot codes for 25 lb. pack: MG0076503, MG0077469, AND MG0073506; Lot codes for 50 lb. pack: MG0076762 AND MG0073750;
Part Number 05.001.012 Lot Numbers AV18166 AV19044 AV20666
Material Number 10376770, Lot Number 3JD018, Expiration: April 2015
Retail: Item #000023 BBQ Flavor Best Before: 5/4/16, 6/11/2016, 8/13/16 Canadian: Item #010023 BBQ Flavor Best Before: 5/4/16
Retail: Item # 003163 Loco Chipotle Flavor; Use By 8/12/16
Lot Code: 6908; Hines Nut Company Best By Dates: September 21, 2015 to October 1, 2015; Harris-Teeter Best By Dates: September 28, 2015.
The date of repacking is stamped on the package. Date is stamped on the bottom of the information panel. It contains the three letter abbreviation for the month in capital letters followed by the two digit day and 4 digit year. Example FEB 02 2015.
Uncoded; distributed September 2014 through February 1, 2015
Lot 15023 (represents Julianne date of manufacture)
All ''SELL BY'' Date codes of May 15, 2015 and earlier
All lots of Catalog Numbers: FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126
Production date: December 2014 Expiry date: December 2017 Batch No. NO81114-P3 Lot 53656 & Batch No. N081114-P3, Lot 53657 net wt 50#
ExacTrac versions 6.x including versions 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0. Model/Catalog Numbers: 49971, CBCT IMPORT & ALIGNMENT SOFTWARE; 20836, EXACTRAC 6.0 VARIAN CBCT LICENSE; The software may be contained in configured items: 48320, ET UPGRADE SOFTWARE 6.0 TO 6.1; 48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA; 49973B, ET DATA PREP / REVIEW SYSTEM; 49973A, ET DATA PREP / REVIEW SYSTEM; 49973, ET DATA PREP / REVIEW SYSTEM; 49998B, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 49998A, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 49998, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 48304, ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT; 48302, ET DATA PREP / REVIEW SYSTEM
Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498

Product Quantity
157 cases of 12 oz.; 324 cases of 10 oz.; 288 cases of 16 oz.
42,500 lbs was distributed to one customer; and 42,500 lbs was distributed to a second customer

Reason for Recall
Blood products, collected from donors who did not receive a complete physical examination, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VCG battery ignited in a VCG unit when recharging.
The products were shipped without labels declaring the nutrition and ingredients information and the presence of egg, milk, and wheat allergens.
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
The staining intensity decreases over the shelf life.
Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss
Ingredients in label for ''Pastelillos de Guayaba'' (Guava Pastries) do not include soy lecithin.
If the patient sits on either wing, not squarely on the center section of the Stretcher Lift, tipping and injury to the operator or patient could result. The device manual was updated with an additional warning statement.
Ground Cumin is recalled because it contains more than 25 ppm of peanut protein.
Barley & Lentil Soup Spice Mix is recalled because it may contain traces of peanut protein.
Mild Chili Powder Salt Free is recalled because it contains more than 25 ppm peanut protein.
Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013.
Cumin may contain undeclared peanut protein.
In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged.
Blood product, collected from a donor who tested reactive for the antibody to hepatitis B core antigen (anti-HBc) on two occasions, was distributed.
False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661.
Aloha has recalled protein powder dietary supplements due to the presence of Staphylococcus enterotoxin
Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) assays which was the result of calibrator value miscalculation.
It was discovered that the upper left corner-shaped lead shield in the window in one of the doors of the v|tome|x L240 installed had lost adhesion and fall out of position, which could lead to gaps in shielding.
It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding.
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
Gluten testing was performed on products labeled gluten free. The results received back were >20ppm.
Product may be contaminated with Salmonella.
Sunfood is recalling Sacha Inchi Powder because it has the potential to be contaminated with Staphylococcus enterotoxin.
Listeria contamination was discovered at Henry's Farm, Inc., a grower and manufacturer of soybean sprouts, after sampling by the US Food and Drug Administration. Sample 875780 . Henrys Farm Inc. of Woodford, VA is recalling all packages of Soybean Sprouts because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals with weakened immune systems. Although healthy individuals may suffer only short term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Food for Lane County received and repackaged a product containing cumin which is being recalled due to the potential of being contaminated with peanut protein.
Colonna Brothers is recalling ground cumin received from its supplier that may be contaminated with peanut proteins.
Unilever United States, Inc. is voluntarily recalling a limited number of tubs of Breyers No Sugar Added Salted Caramel Swirl because they may inadvertently contain almonds, which are not listed as an ingredient on the label.
Vitamin Cottage Natural Food Markets, Inc. is recalling two lots of Natural Grocers brand Organic Garlic Powder because it has the potential to be contaminated with Salmonella.
The products contain undeclared egg and FD&C colors Yellow 5 or 6, Red 3 or 40, and/or Blue 1 from the royal icing component used on the finished pops.
Failed Impurities/Degradation Specifications; 12 month stability testing.
UNCLE BENS(R) Ready to Heat Pouches have the potential for containing metal fragments.
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
Hummingbird Brand Organic Chocolate Hazelnut Butter is recalled due to undeclared milk.
Lack of Assurance of Sterility; due to leaking vials
The product was found to be contaminated with Salmonella based on sampling and analysis.
Complaint received from NYSDAM regarding undeclared colors in Cocolo cookies.
El Popocatepetl Ind., Inc. of Chicago, Illinois is voluntarily recalling El Popocatepetl's 8 in. Chipotle, Spinach Pesto, and Sun Dried Tomato Wraps because they may contain undeclared milk and Yellow No. 5.
El Popocatepetl Ind., Inc. of Chicago, Illinois is voluntarily recalling El Popocatepetl's 8 in. Chipotle, Spinach Pesto, and Sun Dried Tomato Wraps because they may contain undeclared milk. The milk ingredient was found in the ''butter flavoring'' which was used in all three flavored wraps.
Titan Spine, LLC became aware of the TCS Straight Hexlobular #6 Drivers (5210-1004) tip shearing off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drivers (5210-1004) Lot# G150101 from the field.
Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.
Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 components on the P/N09010 RoHS boards of the Coblator II Controller (Model RF8000E).
Agridient Inc. received information that gluten they had repackaged and distributed contained undeclared allergen peanut. Agridient Inc. distributed gluten with undeclared allergen peanut to two customers and issued notice of recall to one customer on 02/05/2015, and the second customer on 02/21/2015 via emailed letter.
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the ''Power-On Self Test'' due to a keypad issue.
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.
Blood product, collected from a donor who emigrated from an area considered endemic for malaria, was distributed.
The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.
RaySearch Laboratories AB became aware of an issue found with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.
GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.
Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.
The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur.
Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.
Blood product, collected from an ineligible donor, was distributed.
Plateletpheresis products, lacking assurance of proper leukoreduction, were distributed.
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Blood products, with a platelet yield that exceeded the maximum specification, were distributed.