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High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6...
Medical Devices·992 affected·Jun 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6...
Medical Devices·648 affected·Jun 21, 2012
High RiskFDA
Elekta, Inc.
Monaco Product Usage: Planning of radiation therapy
Medical Devices·38 affected·Jun 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulati...
Medical Devices·992 affected·Jun 21, 2012
High RiskFDA
Medtech Products, Inc.
Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, ...
Drugs·12,720 affected·Jun 20, 2012
High RiskFDA
Philips Healthcare Inc.
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventric...
Cardiac Devices·35 affected·Jun 20, 2012
High RiskFDA
Philips Healthcare Inc.
Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3...
Cardiac Devices·58,701 affected·Jun 20, 2012
High RiskFDA
Gulf South Medical Supply Inc
Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usa...
Medical Devices·275 affected·Jun 20, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Medical Devices·15 affected·Jun 20, 2012
High RiskFDA
Philips Healthcare Inc.
Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MR...
Cardiac Devices·2,914 affected·Jun 20, 2012
High RiskFDA
Giusto's Specialty Foods Llc
Giusto's Wheat Germ, Raw, Net Wt. 25 lb, (11.34 Kg) paper bag; Item number: 154205 Giusto's 344 Littlefield Ave. South Francisco, C...
Food·7,544 affected·Jun 19, 2012
High RiskFDA
Molded Products Inc
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
Medical Devices·1,200 affected·Jun 19, 2012
High RiskFDA
Eos Imaging Inc
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Diagnostic Devices·12 affected·Jun 19, 2012
High RiskFDA
Stryker Endoscopy
Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distrib...
Surgical Devices·6,388 affected·Jun 19, 2012
High RiskFDA
Sr Rosati, Inc
Rosati Cry Baby Sour Watermelon water ice, 6 fl oz
Beverages·4,608 affected·Jun 18, 2012
High RiskFDA
J&s Group
Frozen Oysters (IQF), Net Weight: 30 lbs (6/5lbs).
Seafood·779 affected·Jun 18, 2012
High RiskFDA
Ultradent Products, Inc.
Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, wh...
Food·17 affected·Jun 18, 2012
High RiskFDA
Ultradent Products, Inc.
Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is aqua, ...
Food·668 affected·Jun 18, 2012
High RiskFDA
Ultradent Products, Inc.
Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with bla...
Food·4,083 affected·Jun 18, 2012
High RiskFDA
Red Chamber Company
Frozen Korean Oyster Meat I.Q.F.: , 1) 40x8oz., UPC 19964 30091; 2) 1x25lbs, .; 3) 5x4lbs.UPC 19964 30092
Meat & Poultry·1 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung syst...
Cardiac Devices·484 affected·Jun 18, 2012
High RiskFDA
Cardiovascular Systems, Inc.
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxid...
Medical Devices·27 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 ho...
Medical Devices·461 affected·Jun 18, 2012
High RiskFDA
Varian Medical Systems, Inc. Oncology Systems
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Va...
Medical Devices·7,113 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours ...
Medical Devices·26 affected·Jun 18, 2012
High RiskFDA
Safe N Simple, Llc
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
Medical Devices·17,592 affected·Jun 18, 2012
High RiskFDA
Hill-rom, Inc.
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
Surgical Devices·7,843 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorpo...
Medical Devices·648 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours...
Medical Devices·1,096 affected·Jun 18, 2012
High RiskFDA
Synthes Usa Hq, Inc.
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. ...
Medical Devices·1,602 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 ho...
Medical Devices·310 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung ...
Cardiac Devices·286 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours ...
Medical Devices·274 affected·Jun 18, 2012
High RiskFDA
Deroyal Industries Inc
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
Surgical Devices·303 affected·Jun 16, 2012
High RiskFDA
Coca-cola Refreshments Usa, Inc.
Coca Cola Cherry Zero, 20 fl. oz. (1.25 pt), The Coca Cola Company.
Food·119 affected·Jun 15, 2012
High RiskFDA
Cj Foods, Inc., A Division Of Cj America
CJ Het Oyster (CJ Frozen Oyster), 40x8oz.. Material#912329, Frozen Oyster (KR 12 SP 050110), Material#912330, Frozen Oyster (KR 12 SP...
Seafood·1,635 affected·Jun 15, 2012
High RiskFDA
Wang Globalnet
Surasang Chanbada Frozen Oyster I.Q.F (8oz), 40pack/case
Seafood·1,572 affected·Jun 15, 2012
High RiskFDA
Itoen (usa) Inc
Itoen Green Tea 11.5 fl oz (340 mL) can. Natural Source of Antioxidants; 0 calories, no sugar: ITO-EN USA Inc. 125 Puuhale Road H...
Beverages·10 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Encision, Inc.
AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosu...
Surgical Devices·48 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Korean Farm, Inc.
IQF Oysters 3lbs, Assi Brand, Item# 20083K,10x3 lb; Oyster Block, Assi Brand, item# 20085K, 30x1 lb; Oysters 8 oz - Tiny, Assi Bran...
Seafood·638 affected·Jun 14, 2012
High RiskFDA
Christian Cheese, Llc
Christian Cheese Horseradish Cheddar Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetabl...
Dairy·0 affected·Jun 14, 2012
High RiskFDA
Christian Cheese, Llc
Christian Cheese Sun-Dried tomato Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable ...
Dairy·15 affected·Jun 14, 2012