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High RiskFDA
Pepsi Beverages Company
Lipton Pure Leaf Iced NTS Honey Green Tea 12 Pack
Beverages·11,880 affected·May 1, 2014
High RiskFDA
Pepsi Beverages Company
Lipton Pure Leaf Iced Tea Unsweetened 18.5OZ PL 6 Pack and 12 Pack
Beverages·57,552 affected·May 1, 2014
High RiskFDA
Boehringer Ingelheim Roxane Inc
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Oral Drugs·5,364 affected·May 1, 2014
High RiskFDA
Teva Pharmaceuticals Usa
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
Oral Drugs·9,882 affected·May 1, 2014
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is p...
Medical Implants·22 affected·May 1, 2014
High RiskFDA
American Spoon Foods, Inc.
American Spoon¿ Sour Cherry PRESERVES Richer in Fruit (56 Brix) Made in Small Batches Net Wt. 9.5 oz/269g, glass jar INGREDIENTS: Red Tar...
Dairy·2,887 affected·Apr 30, 2014
High RiskFDA
Microport Orthopedics Inc.
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
Surgical Devices·140 affected·Apr 30, 2014
High RiskFDA
Abbott Laboratories
HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglo...
Diagnostic Devices·183 affected·Apr 30, 2014
High RiskFDA
Varian Medical Systems, Inc.
Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in rel...
Medical Devices·32 affected·Apr 30, 2014
High RiskFDA
Mako Surgical Corporation
Robotic Arm Interactive Orthopedic System (RIO)
Medical Devices·249 affected·Apr 30, 2014
High RiskFDA
Agfa Corp.
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creat...
Diagnostic Devices·0 affected·Apr 30, 2014
High RiskFDA
Whole Foods Market Group Inc.
Bolivian Artichoke Salad sold at Whole Foods 10 lb bulk bags, refrigerated
Produce·190 affected·Apr 29, 2014
High RiskFDA
Mercola Group
Organic Cocoa Cassava bars, 1.59 oz (45 g), individually packaged in foil pouches and sold under the Dr. Mercola brand. Sold at retail lo...
Food·98,698 affected·Apr 29, 2014
High RiskFDA
Hk Galleria Wholesale L.p
Yangban Rice Porridge with Abalone, Net Wt. 10.16 oz (288 g), UPC 8 83298 61617 3, 24 cans/case
Food·460 affected·Apr 29, 2014
High RiskFDA
Independent Nutrition Center, Inc.
Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-cou...
Supplements·209 affected·Apr 29, 2014
High RiskFDA
Flawless Beauty Llc
Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: S...
Injectable Drugs·0 affected·Apr 29, 2014
High RiskFDA
Flawless Beauty Llc
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories...
Injectable Drugs·0 affected·Apr 29, 2014
High RiskFDA
Flawless Beauty Llc
Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count...
Injectable Drugs·0 affected·Apr 29, 2014
High RiskFDA
Flawless Beauty Llc
Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box,...
Injectable Drugs·0 affected·Apr 29, 2014
High RiskFDA
Flawless Beauty Llc
Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuti...
Injectable Drugs·0 affected·Apr 29, 2014
High RiskFDA
Flawless Beauty Llc
Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., ...
Injectable Drugs·0 affected·Apr 29, 2014
High RiskFDA
Childrens Medical Ventures
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
Medical Devices·112 affected·Apr 29, 2014
High RiskFDA
Synthes, Inc.
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0...
Medical Implants·6,690 affected·Apr 29, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conju...
Cardiac Devices·16,337 affected·Apr 29, 2014
High RiskFDA
Ferring Pharmaceuticals Inc
TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Ph...
Injectable Drugs·129,060 affected·Apr 28, 2014
High RiskFDA
T.h. Seafood Inc.
Raw, frozen, vacuum-packaged rock fish (portions, fillets, and whole fish, various sizes).
Seafood·2,000 affected·Apr 25, 2014
High RiskFDA
T.h. Seafood Inc.
Raw, frozen, vacuum-packaged salmon (portions, fillets, and whole fish, various sizes).
Seafood·2,000 affected·Apr 25, 2014
High RiskFDA
T.h. Seafood Inc.
Raw, frozen, vacuum-packaged halibut (portions, fillets, and whole fish of various sizes).
Seafood·2,050 affected·Apr 25, 2014
High RiskFDA
T.h. Seafood Inc.
Raw, frozen, vacuum-packaged black cod (portions, fillets, and whole fish, various sizes).
Seafood·2,100 affected·Apr 25, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K...
Medical Devices·39 affected·Apr 25, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008...
Medical Devices·79 affected·Apr 25, 2014
High RiskFDA
Cryolife, Inc.
BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods...
Surgical Devices·6,190 affected·Apr 25, 2014
High RiskFDA
Stonyfield Farm
Stonyfield YoBaby Vanilla Organic Whole Milk Yogurt multipack 6 pack plastic cups/4 oz each UPC-052159701178
Dairy·427 affected·Apr 24, 2014
High RiskFDA
Stonyfield Farm
Stonyfield YoToddler Raspberry/Pear Cereal Organic Whole Milk Yogurt with Fruit and Cereal, multipack 6 pack plastic cups/4 oz each UPC-...
Dairy·440 affected·Apr 24, 2014
High RiskFDA
Stonyfield Farm
Stonyfield YoBaby Pear/Peach Organic Whole Milk Yogurt multipack- 6 pack plastic cups- 3 peach and 3 pear/4 oz each cups UPC-052159701161
Dairy·3,429 affected·Apr 24, 2014
High RiskFDA
Actavis Laboratories, Fl, Inc.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, ...
Oral Drugs·36,538 affected·Apr 24, 2014
High RiskFDA
Baxter Healthcare Corp.
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthca...
Injectable Drugs·19,152 affected·Apr 24, 2014
High RiskFDA
Actavis Laboratories, Fl, Inc.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, ...
Oral Drugs·6,041 affected·Apr 24, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, ...
Diagnostic Devices·5 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TUMOR RES. PACK 9733553 AxiEM S.M.
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
KIT, 9731427, THORACIC TACTILE PROBES
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as ...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue defici...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
ENT PRGM 9734636 ADD FUSION NAV AxiEM
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
MOUSE 9732721 STERILE O-ARM 10PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue defi...
Medical Devices·0 affected·Apr 24, 2014