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High RiskFDA
Edwards Lifesciences, Llc
Thin-Flex Venous Cannula, Model Number:TF292902A
Medical Devices·8,915 affected·Nov 4, 2015
High RiskFDA
Ormco/sybronendo
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Medical Devices·161 affected·Nov 4, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ra...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnosti...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, includin...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and n...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interve...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic a...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagn...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry Syste...
Diagnostic Devices·51 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including dia...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfa...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular an...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular an...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Angiodynamics Inc.
NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - ...
Surgical Devices·136 affected·Nov 3, 2015
High RiskFDA
Angiodynamics Inc.
NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - Th...
Surgical Devices·45 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: In...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular an...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Angiodynamics Inc.
NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - ...
Surgical Devices·8 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by traine...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: In...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnost...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD...
Diagnostic Devices·157 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA ...
Diagnostic Devices·1,637 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Soft...
Diagnostic Devices·200 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
Medical Devices·15 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neuro...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Bake Rite Rolls Divison Of Northeast Foods
100% Whole Grain Hot Dog Rolls
Food·6,852 affected·Nov 2, 2015
High RiskFDA
Synthes (usa) Products Llc
2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and...
Medical Devices·229 affected·Nov 2, 2015
High RiskFDA
Trumpf Medical Systems, Inc.
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
Surgical Devices·20,713 affected·Nov 2, 2015
High RiskFDA
The Anspach Effort, Inc.
Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
Surgical Devices·50 affected·Nov 2, 2015
High RiskFDA
Norpac Foods, Inc. (plant #8)
IQF FLAV-R-PAC Cut Wax Beans, there are 12/2 lbs. bags per case. Catalog # 07570. Product was distributed to Food Service accounts....
Frozen Food·792 affected·Oct 30, 2015
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific...
Diagnostic Devices·23 affected·Oct 30, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
Medical Devices·17 affected·Oct 30, 2015
High RiskFDA
Hormel Foods Corporation
Skippy Creamy 25% Less Fat Reduced Fat Peanut Butter Spread Net Wt. 16.3 OZ (1 lb 0.3 OZ) 462g in plastic jars, UPC: 037600105002
Dairy·153 affected·Oct 29, 2015
High RiskFDA
Amerisource Health Services
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packag...
Oral Drugs·2,784 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Medical Devices·323 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT Computed Tomography X-ray system
Medical Devices·31 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Computed Tomography X-ray system
Medical Devices·51 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray system
Medical Devices·177 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Medical Devices·7 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
Medical Devices·133 affected·Oct 29, 2015