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High RiskFDA
Genentech Inc
Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
Injectable Drugs·12,791 affected·Sep 20, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
Medical Devices·364 affected·Sep 20, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, ...
Medical Devices·179 affected·Sep 20, 2012
High RiskFDA
Sorin Group Usa, Inc.
SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a...
Medical Devices·8 affected·Sep 20, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, region...
Medical Devices·72 affected·Sep 20, 2012
High RiskFDA
Captiva Spine, Inc
CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pe...
Medical Devices·10 affected·Sep 20, 2012
High RiskFDA
Zimmer, Inc.
The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for e...
Medical Devices·24 affected·Sep 20, 2012
High RiskFDA
Medline Industries Inc
Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: Th...
Surgical Devices·18 affected·Sep 20, 2012
High RiskFDA
Zimmer, Inc.
The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for de...
Medical Implants·170 affected·Sep 20, 2012
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Medical Devices·10 affected·Sep 20, 2012
High RiskFDA
Sorin Group Usa, Inc.
SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopul...
Medical Devices·12 affected·Sep 20, 2012
High RiskFDA
Sorin Group Usa, Inc.
Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass f...
Medical Devices·2 affected·Sep 19, 2012
High RiskFDA
Sorin Group Usa, Inc.
S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass f...
Medical Devices·5 affected·Sep 19, 2012
High RiskFDA
Sorin Group Usa, Inc.
S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass ...
Medical Devices·35 affected·Sep 19, 2012
High RiskFDA
Medtronic Vascular, Inc.
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Medical Implants·1,000 affected·Sep 19, 2012
High RiskFDA
Trumpf Medical Systems, Inc.
Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or e...
Surgical Devices·275 affected·Sep 19, 2012
High RiskFDA
Sorin Group Usa, Inc.
S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass fo...
Medical Devices·2 affected·Sep 19, 2012
High RiskFDA
Dale & Thomas Popcorn, Llc
Popcorn Indiana Kettlecorn Net Wt. 9.75 oz UPC 84357100050 Net Wt. 14 oz. UPC 843571000693 Net Wt. 8 pack bag 0.7 oz. UPC 843571001676...
Snacks & Candy·83,256 affected·Sep 18, 2012
High RiskFDA
Dale & Thomas Popcorn, Llc
Popcorn Indiana Dark Fudge Chocolate Chip Kettlecorn Net Wt. 5.5 oz, UPC 843571003076 Net Wt. 6 oz UPC Popcorn Indiana LLC 1 Cedar La...
Snacks & Candy·17,070 affected·Sep 18, 2012
High RiskFDA
Dale & Thomas Popcorn, Llc
Popcorn Indiana Aged White Cheddar Popcorn 0.8 oz - UPC 843571004233 3.5 oz- UPC 843571000532 8 oz- UPC 843571000785 8.3 oz - UPC 8435...
Snacks & Candy·398,910 affected·Sep 18, 2012
High RiskFDA
Dale & Thomas Popcorn, Llc
Popcorn Indiana Roasted Peanut Caramel Popcorn Net Wt. 7 oz, UPC 843571003861 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Mad...
Snacks & Candy·10,524 affected·Sep 18, 2012
High RiskFDA
Dale & Thomas Popcorn, Llc
Popcorn Indiana Caramel Popcorn Net Wt. 7.4 oz. UPC 843571003045 Net Wt. 8 oz - UPC 843571002369 Popcorn Indiana LLC 1 Cedar Lane, Eng...
Snacks & Candy·18,054 affected·Sep 18, 2012
High RiskFDA
Dale & Thomas Popcorn, Llc
Popcorn Indiana Bacon Ranch Popcorn Net Wt. 3.5 oz - UPC 843571001942 Net Wt. 7.75 oz - UPC 843571001935 Net Wt. 8.3oz. - UPC 84357100...
Snacks & Candy·36,246 affected·Sep 18, 2012
High RiskFDA
Dale & Thomas Popcorn, Llc
Popcorn Indiana Almond Biscotti Caramel Popcorn Net Wt. 6.5 oz. UPC 843571003809 Net Wt. 7 oz UPC 843571003854 Popcorn Indiana LLC 1 C...
Snacks & Candy·22,206 affected·Sep 18, 2012
High RiskFDA
Dale & Thomas Popcorn, Llc
Popcorn Indiana American Cheese Popcorn Net Wt. 7 oz. UPC 843571004134 Distributed by Popcorn, Indiana LLC 1 Cedar Lane, Englewood, NJ...
Dairy·3,810 affected·Sep 18, 2012
High RiskFDA
Dale & Thomas Popcorn, Llc
Popcorn Indiana Wasabi Reserve Popcorn Net Wt. 5.5 oz UPC 843571002048 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in th...
Snacks & Candy·6,060 affected·Sep 18, 2012
High RiskFDA
Dale & Thomas Popcorn, Llc
Popcorn Indiana Drizzled Black & White Kettlecorn Net Wt. 6 oz. UPC 843571002345 Canada - Drizzled Black & White Kettlecorn Marbre Noir...
Snacks & Candy·17,664 affected·Sep 18, 2012
High RiskFDA
Dale & Thomas Popcorn, Llc
Popcorn Indiana Salt and Pepper Popcorn Net Wt. 6.9 oz UPC 843571003557 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in t...
Snacks & Candy·1,716 affected·Sep 18, 2012
High RiskFDA
Dale & Thomas Popcorn, Llc
Popcorn Indiana Apple Crisp Popcorn Net Wt. 6.5 oz. UPC 843571003243 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Snacks & Candy·3,948 affected·Sep 18, 2012
High RiskFDA
Ralcorp Frozen Bakery Products
GFS Individually Wrapped Blueberry Muffins, 1.8 Ounce, in 80 count case, Net Weight 9 lb./4.1 kg; Manufactured for Gordon Food Service, ...
Produce·1,542 affected·Sep 18, 2012
High RiskFDA
Elekta, Inc.
MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply e...
Diagnostic Devices·300 affected·Sep 18, 2012
High RiskFDA
Becton Dickinson & Co.
Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
Diagnostic Devices·86 affected·Sep 18, 2012
High RiskFDA
Trophy Sas
CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for...
Medical Devices·167 affected·Sep 18, 2012
High RiskFDA
Trophy Sas
CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radio...
Medical Devices·167 affected·Sep 18, 2012
High RiskFDA
Trophy Sas
CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for...
Medical Devices·167 affected·Sep 18, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brillian...
Medical Devices·1,474 affected·Sep 18, 2012
High RiskFDA
Instratek, Incorporated
Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger re...
Medical Devices·235 affected·Sep 18, 2012
High RiskFDA
Dermacare, Inc.
UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by...
Drugs·25,956 affected·Sep 17, 2012
High RiskFDA
Dermacare, Inc.
UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed b...
Drugs·43,272 affected·Sep 17, 2012
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for i...
Diabetes Devices·2,939 affected·Sep 17, 2012
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing...
Diabetes Devices·4,494 affected·Sep 17, 2012
High RiskFDA
Boston Scientific Corporation
Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequenc...
Surgical Devices·19,716 affected·Sep 17, 2012
High RiskFDA
Boston Scientific Corporation
LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable,...
Surgical Devices·19 affected·Sep 17, 2012
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for pro...
Diabetes Devices·2,152 affected·Sep 17, 2012
High RiskFDA
Ge Healthcare It
Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as...
Diagnostic Devices·748 affected·Sep 15, 2012
High RiskFDA
Hologic, Inc.
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging S...
Surgical Devices·46 affected·Sep 14, 2012
High RiskFDA
Advandx Inc
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae ...
Diagnostic Devices·187 affected·Sep 14, 2012
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of lega...
Medical Devices·422 affected·Sep 14, 2012