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High RiskFDA
Gyrus Acmi, Incorporated
Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in ...
Medical Devices·12,020 affected·May 8, 2015
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301C
Medical Devices·459 affected·May 8, 2015
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-303A
Medical Devices·459 affected·May 8, 2015
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301A
Medical Devices·459 affected·May 8, 2015
High RiskFDA
Viewray Incorporated
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiother...
Medical Devices·3 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Atrium Medical Corporation
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Medical Devices·390 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c ...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi M...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/H...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in ser...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Atrium Medical Corporation
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
Medical Devices·390 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems fo...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Atrium Medical Corporation
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
Medical Devices·1,170 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for us...
Diagnostic Devices·6,255 affected·May 7, 2015
High RiskFDA
Tortilleria Provincia
Tortilleria Provincia Refrigerate After Purchase Blue Corn Tortillas, Net Wt. 16 oz, 0 89780 10000 1 & 64 oz, 0 89780 10001 8, Tortilleri...
Food·96 affected·May 6, 2015
High RiskFDA
Smith & Nephew, Inc.
R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabu...
Medical Implants·40 affected·May 6, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in...
Medical Devices·2,713 affected·May 6, 2015
High RiskFDA
Smith & Nephew, Inc.
R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabul...
Medical Implants·12 affected·May 6, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. Fo...
Diagnostic Devices·17 affected·May 6, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for...
Medical Devices·131 affected·May 6, 2015
High RiskFDA
Smith & Nephew, Inc.
R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabul...
Medical Implants·0 affected·May 6, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary ...
Medical Devices·163 affected·May 6, 2015
High RiskFDA
Flying Food Group - Law
evolution FRESH brand Fresh Berries & Honey, Nonfat Greek Yogurt with Strawberries, Blueberries, Pure Honey, & Granola; NET WT 6.5 OZ/...
Dairy·2,568 affected·May 5, 2015
High RiskFDA
Edwards Lifesciences, Llc
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardi...
Cardiac Devices·978 affected·May 5, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended...
Medical Devices·158 affected·May 5, 2015
High RiskFDA
Natural Creations Inc
Natural Creations Glucosamine MSM 90 capsules packaged in 250 cc white plastic containers with 52 bottles per case.
Food·644 affected·May 4, 2015
High RiskFDA
Creative Food Concepts
Coconut Water with Thai Lime, 12 bottles/case, 12 oz (355 mL)
Beverages·324 affected·May 4, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product ...
Medical Devices·72 affected·May 4, 2015
High RiskFDA
Smiths Medical Asd Inc
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX ...
Medical Devices·6,000 affected·May 4, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Medical Devices·110 affected·May 4, 2015
High RiskFDA
Poco Dolce Confections, Inc.
Poco Dolce Bittersweet Chocolate: Ginger Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocola...
Dairy·34 affected·May 1, 2015
High RiskFDA
Poco Dolce Confections, Inc.
Poco Dolce Bittersweet Chocolate: Sesame Toffee Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet ...
Dairy·34 affected·May 1, 2015
High RiskFDA
Poco Dolce Confections, Inc.
Poco Dolce Bittersweet Chocolate: Burnt Caramel Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet ...
Dairy·34 affected·May 1, 2015
High RiskFDA
4 Him Food Group Llc
Salted Caramel Premium Puffed Corn, Cosmo Creations brand, Nitrogen filled, 3-layer laminate packaging, Net weight 14 oz., UPC 8 51710 00...
Food·33,240 affected·May 1, 2015
High RiskFDA
Poco Dolce Confections, Inc.
Poco Dolce Bittersweet Chocolate: Almond Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocola...
Dairy·34 affected·May 1, 2015
High RiskFDA
Poco Dolce Confections, Inc.
Poco Dolce Bittersweet Chocolate: Aztec Chili Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Ch...
Dairy·34 affected·May 1, 2015
High RiskFDA
Poco Dolce Confections, Inc.
Poco Dolce Bittersweet Chocolate: Almond Coconut Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet...
Dairy·34 affected·May 1, 2015
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integ...
Medical Devices·123 affected·May 1, 2015
High RiskFDA
Biomet, Inc.
Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to...
Medical Devices·19 affected·May 1, 2015
High RiskFDA
Terumo Cardiovascular Systems Corporation
Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on t...
Medical Devices·1,713 affected·May 1, 2015
High RiskFDA
Terumo Cardiovascular Systems Corporation
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on t...
Medical Devices·1,713 affected·May 1, 2015
High RiskFDA
Beaver-visitec International Inc.
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
Surgical Devices·214 affected·May 1, 2015
High RiskFDA
Ferno-washington Inc
Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
Medical Devices·26 affected·May 1, 2015
High RiskFDA
Beaver-visitec International Inc.
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
Surgical Devices·621 affected·May 1, 2015
High RiskFDA
Beaver-visitec International Inc.
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
Surgical Devices·384 affected·May 1, 2015