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High RiskFDA
Vital Images, Inc.
Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and...
Cardiac Devices·102 affected·Mar 15, 2013
High RiskFDA
Intuitive Surgical, Inc.
IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes prot...
Surgical Devices·1,642 affected·Mar 15, 2013
High RiskFDA
Intuitive Surgical, Inc.
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
Surgical Devices·1,642 affected·Mar 15, 2013
High RiskFDA
F.h.g Corporation Dba Integrity Nutraceuticals
MUSCLEPHARM brand COMBAT POWDER (R), BANANA CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS (907...
Dairy·2,427 affected·Mar 14, 2013
High RiskFDA
Producers Peanut Company Inc
Happy Kids Creamy Peanut Butter, packed in 8 oz, 12 oz, 28 oz, 40 oz jars; packed 12 jars/box and 6 jars/box (40 oz), and labeled in part...
Dairy·1,122 affected·Mar 14, 2013
High RiskFDA
Producers Peanut Company Inc
Bulk Creamy/Smooth Peanut butter, packed in plastic 4 lb tub, packed 6 tubs/box; 5 lb tub, packed 6 tubs/box, and 35 lb buckets under pri...
Dairy·1,101 affected·Mar 14, 2013
High RiskFDA
F.h.g Corporation Dba Integrity Nutraceuticals
MUSCLEPHARM brand COMBAT POWDER (R), COOKIES 'N' CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS...
Dairy·2,541 affected·Mar 14, 2013
High RiskFDA
Producers Peanut Company Inc
America Farm Peanut Granules, bulk packed in 30 lb plastic bags in a box, and labeled in part ***Manufactured by Producers Peanut Co., In...
Produce·1 affected·Mar 14, 2013
High RiskFDA
Producers Peanut Company Inc
Happy Kids Crunchy Peanut butter, packed in 8 oz, 12 oz, 28 oz, packed 12 jars/cs and 40 oz jars, packed 6 jars/cs; jars are labeled in p...
Dairy·506 affected·Mar 14, 2013
High RiskFDA
Med Prep Consulting, Inc.
All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ...
Drugs·0 affected·Mar 14, 2013
High RiskFDA
Synvasive Technology Inc
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. ...
Surgical Devices·100 affected·Mar 14, 2013
High RiskFDA
Spinefrontier, Inc.
Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle scre...
Medical Implants·8 affected·Mar 14, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange du...
Surgical Devices·225 affected·Mar 13, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. ...
Surgical Devices·27,682 affected·Mar 13, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
Diagnostic Devices·3,871 affected·Mar 13, 2013
High RiskFDA
Purely American, Inc.
Chicken Noodle Soup Mix, "9 oz cello bag, Contents: All natural enriched semolina flour***PURELY AMERICAN 5991 Industrial Park Road, Athe...
Meat & Poultry·278 affected·Mar 12, 2013
High RiskFDA
Purely American, Inc.
MARIN COUNTY CARROT CAKE MIX 18.5 oz coffee bag Contents: Unbleached white flour; whole wheat flour, sugar, spices, non-aluminum baking p...
Bakery & Grains·1 affected·Mar 12, 2013
High RiskFDA
Purely American, Inc.
LONG ISLAND BAYMEN SEAFOOD CHOWDER MIX 15 oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and be...
Seafood·60 affected·Mar 12, 2013
High RiskFDA
Purely American, Inc.
MAMA MARINO'S MINESTRONE SOUP MIX 15 oz cello bag Contents: Assorted beans & barley, Enriched semolina flour***spray dried tomato, spinac...
Beverages·413 affected·Mar 12, 2013
High RiskFDA
Purely American, Inc.
GILROY GARLIC PASTA STIR FRY MIX 11oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powd...
Beverages·73 affected·Mar 12, 2013
High RiskFDA
Purely American, Inc.
INDIAN RIVER ORANGE DROP COOKIES MIX 17 oz coffee bag Contents: Unbleached white flour; granulated sugar, confectioner's sugar, orange pe...
Bakery & Grains·25 affected·Mar 12, 2013
High RiskFDA
Purely American, Inc.
Pasta Salad Mix, Contents: All natural enriched semolina flour, spray dried tomato, spinach and beet powders, water, spices, dried tomato...
Beverages·163 affected·Mar 12, 2013
High RiskFDA
Purely American, Inc.
SHENANDOAH VALLEY APPLE AND SPICE CAKE MIX 15.5 oz coffee bag Contents: Unbleached white flour; cane sugar, spices, non-aluminum baking p...
Bakery & Grains·230 affected·Mar 12, 2013
High RiskFDA
Purely American, Inc.
SANTA FE CORNBREAD MIX 12.25 oz coffee bag Contents: Yellow corn meal, unbleached white flour; dehydrated garlic, onion, paprika, bell pe...
Bakery & Grains·63 affected·Mar 12, 2013
High RiskFDA
Purely American, Inc.
ADIRONDACK GETAWAY PASTA TOSS MIX 11oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet pow...
Beverages·20 affected·Mar 12, 2013
High RiskFDA
Purely American, Inc.
Pasta Salad Mix, "10 oz cello bag, Contents: All natural enriched semolina flour, spray dried tomato, spinach and beet powders, water, pa...
Beverages·91 affected·Mar 12, 2013
High RiskFDA
Ge Healthcare It
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities a...
Medical Devices·5 affected·Mar 12, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, Syst...
Medical Devices·515 affected·Mar 12, 2013
High RiskFDA
Custom Ultrasonics, Inc.
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Medical Devices·118 affected·Mar 12, 2013
High RiskFDA
Ge Healthcare It
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities a...
Medical Devices·7 affected·Mar 12, 2013
High RiskFDA
Palmer Natural Products
Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx, distributed by BoostYourGrade, BoostYourGrade...
Oral Drugs·250 affected·Mar 11, 2013
High RiskFDA
Palmer Natural Products
Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. .
Oral Drugs·4,103 affected·Mar 11, 2013
High RiskFDA
Palmer Natural Products
Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYour...
Oral Drugs·472 affected·Mar 11, 2013
High RiskFDA
Palmer Natural Products
Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60 count bottle, c) 90 count, d) 180 count , OTC, Boo...
Oral Drugs·557 affected·Mar 11, 2013
High RiskFDA
Palmer Natural Products
NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle, OTC Manufactured & Packaged in the USA for NOOTROP...
Oral Drugs·672 affected·Mar 11, 2013
High RiskFDA
Palmer Natural Products
BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle, OYC, BoostYourGrade, LLC, Orlando, FL 32826
Oral Drugs·723 affected·Mar 11, 2013
High RiskFDA
Palmer Natural Products
Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, ...
Oral Drugs·511 affected·Mar 11, 2013
High RiskFDA
Clinical Specialties Compounding Pharmacy
Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA
Drugs·2,190 affected·Mar 11, 2013
High RiskFDA
Gsms
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only...
Oral Drugs·6,158 affected·Mar 11, 2013
High RiskFDA
Becton Dickinson & Co.
BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.
Medical Devices·521,160 affected·Mar 11, 2013
High RiskFDA
Becton Dickinson & Co.
BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.
Medical Devices·521,160 affected·Mar 11, 2013
High RiskFDA
Becton Dickinson & Co.
BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.
Medical Devices·521,160 affected·Mar 11, 2013
High RiskFDA
Keystone Dental Inc
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Medical Implants·120 affected·Mar 11, 2013
High RiskFDA
La Preferida Inc
Metal cans; labeled as containing 29 oz of pinto beans packed in water and salt
Beverages·4,734 affected·Mar 9, 2013
High RiskFDA
Mike-sells Potato Chip Co
Mikesell's Honey Barbecue TOMATO AND SPICES WITH A HINT OF SWEET FLAVORED POTATO CHIPS Gluten Free 1 oz., 2 oz., 6 oz., 10 oz., 16 oz. M...
Snacks & Candy·385,011 affected·Mar 8, 2013
High RiskFDA
Hospira Inc.
LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-ad...
Medical Devices·8,794 affected·Mar 8, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
Medical Devices·81 affected·Mar 8, 2013
High RiskFDA
Hospira Inc.
LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
Medical Devices·69 affected·Mar 8, 2013