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High RiskFDA
Sybron Dental Specialties
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a c...
Medical Devices·1,091 affected·Jun 6, 2013
High RiskFDA
Endogastric Solutions Inc
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of sy...
Medical Devices·5,192 affected·Jun 6, 2013
High RiskFDA
Becton Dickinson & Co.
BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Be...
Medical Devices·42 affected·Jun 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The C...
Diagnostic Devices·0 affected·Jun 6, 2013
High RiskFDA
Becton Dickinson & Co.
BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, a...
Medical Devices·106 affected·Jun 6, 2013
High RiskFDA
Becton Dickinson & Co.
BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Com...
Medical Devices·163 affected·Jun 6, 2013
High RiskFDA
Becton Dickinson & Co.
BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840, packaged in cartons of 20 plates, labeled in part ***...
Medical Devices·92 affected·Jun 6, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnost...
Diagnostic Devices·7,470 affected·Jun 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
Diagnostic Devices·401 affected·Jun 5, 2013
High RiskFDA
Pharmacia & Upjohn Llc
Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, R...
Injectable Drugs·898,900 affected·Jun 4, 2013
High RiskFDA
West-ward Pharmaceutical Corp.
VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA ...
Oral Drugs·118 affected·Jun 4, 2013
High RiskFDA
Invacare Corporation
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
Medical Devices·166,230 affected·Jun 4, 2013
High RiskFDA
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization pro...
Medical Devices·2,447 affected·Jun 4, 2013
High RiskFDA
Baxa Corporation
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished s...
Medical Devices·753 affected·Jun 4, 2013
High RiskFDA
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Medical Devices·865 affected·Jun 4, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay...
Medical Devices·5,480 affected·Jun 3, 2013
High RiskFDA
Beckman Coulter Inc.
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5...
Diagnostic Devices·76 affected·Jun 3, 2013
High RiskFDA
Finger Lakes Farmstead Cheese Company Llc
Finger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schyler County, BIER MECK Gouda, aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES...
Dairy·7 affected·May 31, 2013
High RiskFDA
Oskri Corp.
Box: Oskri, Sesame Bars Date Syrup, Gluten Free, Halal Vegetarian, 5 Bars each 1.9 oz (53g) total weight 9.5 oz (265g), UPC 6 66016 4005...
Food·42 affected·May 31, 2013
High RiskFDA
Synthes (usa) Products Llc
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is...
Medical Devices·119 affected·May 31, 2013
High RiskFDA
Greatbatch Medical
Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane ...
Medical Devices·550 affected·May 31, 2013
High RiskFDA
Cheryls
Fudge Buttercream Frosted Peanut Butter cookies, some of which were mislabeled by being wrapped in Buttercream Frosted Cinnamon Pumpkin c...
Dairy·10,588 affected·May 30, 2013
High RiskFDA
Sandoz Incorporated
Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sa...
Injectable Drugs·297,200 affected·May 30, 2013
High RiskFDA
Terumo Medical Corporation
Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the i...
Diagnostic Devices·20 affected·May 30, 2013
High RiskFDA
Deroyal Industries Inc
GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
Surgical Devices·87 affected·May 30, 2013
High RiskFDA
Terumo Medical Corporation
Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a v...
Surgical Devices·550 affected·May 30, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for...
Medical Devices·7 affected·May 30, 2013
High RiskFDA
Exactech, Inc.
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other d...
Medical Devices·57 affected·May 30, 2013
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Medical Devices·4,691 affected·May 30, 2013
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Medical Devices·4,691 affected·May 30, 2013
High RiskFDA
Hill-rom, Inc.
TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The ...
Surgical Devices·4,121 affected·May 30, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Diclazuril 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Ketamine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Metabolase Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·2 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Dexpanthenol 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Atropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Glutathione 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Acepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Oxytocin 20 units/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·3 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Medroxyprogesterone 150 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Estradiol Cypionate 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Detomidine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·2 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Diphenhydramine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·5 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Cal-Phos 1000 Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Adenosine-Mono-Phosphate Injection, 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Guanabenz 8 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·3 affected·May 29, 2013