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High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neuros...
Medical Implants·71 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue...
Medical Implants·6 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related ...
Medical Implants·6,481 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related ti...
Medical Implants·1,537 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during ...
Medical Implants·246 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue dur...
Medical Implants·497 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related ti...
Medical Implants·285 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during ...
Medical Implants·281 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosur...
Medical Implants·65 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related ti...
Medical Implants·99 affected·May 22, 2014
High RiskFDA
Philips Medical Systems, Inc.
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Medical Devices·42,600 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue durin...
Medical Implants·72 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related...
Medical Implants·41 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related t...
Medical Implants·39 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related ti...
Medical Implants·301 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue duri...
Medical Implants·252 affected·May 22, 2014
High RiskFDA
Brainlab Ag
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimall...
Medical Devices·17 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic ...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Teleflex Medical
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular devi...
Medical Devices·1,000 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instr...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic I...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 031497730...
Diagnostic Devices·462 affected·May 21, 2014
High RiskFDA
Seaspine Inc
Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws...
Medical Implants·7 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic ...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic In...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Inst...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) ...
Diagnostic Devices·149 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. ...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical En...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Royal Rye Llc
KrustaVita¿ Bread of Life brand Sourdough Dark Rye Bread; Net Weight 20 oz (1.25 lb); packed in a clear plastic bag. UPC: 8 5243000200 6.
Bakery & Grains·128 affected·May 20, 2014
High RiskFDA
Cambrex Charles City Inc
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboa...
Drugs·2,351 affected·May 20, 2014
High RiskFDA
West-ward Pharmaceutical Corp.
Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Man...
Oral Drugs·17,347 affected·May 20, 2014
High RiskFDA
Bar Harbor Jam Company
BAR HARBOR JAM COMPANY Maine Old Fashioned Popover Mix; Net Wt 1 lb 5 oz (624g)
Food·132 affected·May 19, 2014
High RiskFDA
Rockman Company Usa Inc
Rockman (Brand) Skinless Peanut, 12 oz. Description: blanched skinless peanut. Packaged in plastic pouch. 12oz/60bags/carton. Pr...
Food·22 affected·May 19, 2014
High RiskFDA
Bar Harbor Jam Company
BAR HARBOR JAM COMPANY Maine Wild Blueberry Muffin Mix; Net Wt. 1 lb 6 oz (624 g)
Produce·132 affected·May 19, 2014
High RiskFDA
Rockman Company Usa Inc
Rockman (Brand) Raw Peanuts with Red Skin, 12 oz. Packaged in plastic pouch. 12oz/60bags/carton. Labeled as "PEANUT" on packaging. ...
Food·47 affected·May 19, 2014
High RiskFDA
Bar Harbor Jam Company
BAR HARBOR JAM COMPANY Maine Wild Blueberry Pancake Mix; Net Wt. 1 lb 6 oz (624 g)
Bakery & Grains·132 affected·May 19, 2014
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen...
Medical Implants·41,180 affected·May 19, 2014
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen...
Medical Implants·41,180 affected·May 19, 2014
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen...
Medical Implants·41,180 affected·May 19, 2014
High RiskFDA
Stryker Endoscopy
Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
Medical Devices·1,992 affected·May 19, 2014
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen...
Medical Implants·41,180 affected·May 19, 2014
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. T...
Medical Devices·113 affected·May 19, 2014
High RiskFDA
Kci Usa, Inc.
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Medical Devices·1,331 affected·May 19, 2014
High RiskFDA
Integra Lifesciences Corp.
Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c De...
Surgical Devices·61 affected·May 19, 2014
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen...
Medical Implants·41,180 affected·May 19, 2014