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High RiskFDA
Philips Medical Systems (cleveland) Inc
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland,...
Medical Devices·112 affected·Aug 21, 2012
High RiskFDA
Covidien Lp
Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue ...
Medical Devices·22,218 affected·Aug 21, 2012
High RiskFDA
Elekta, Inc.
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension...
Medical Devices·52 affected·Aug 21, 2012
High RiskFDA
Remel Inc
Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The re...
Medical Devices·23 affected·Aug 21, 2012
High RiskFDA
Productos El Gauchito
"***Productos El Gauchito Empanadillas Argentinas de Queso y Cebolla (Cheese and OnionTurnovers)***keep frozen or refrigerated***consumer...
Dairy·0 affected·Aug 20, 2012
High RiskFDA
Productos El Gauchito
"***Productos El Gauchito Empanadillas Argentinas de Guayaba y Queso (Guava and Cheese Turnovers)***keep frozen or refrigerated***consume...
Dairy·0 affected·Aug 20, 2012
High RiskFDA
Productos El Gauchito
"***Productos El Gauchito Empanadillas Argentinas Caprese (Caprese Turnovers)***keep frozen or refrigerated***consumer contact: productos...
Frozen Food·0 affected·Aug 20, 2012
High RiskFDA
Productos El Gauchito
"***Productos El Gauchito Empanadillas Argentinas de Espinaca (Spinach Turnovers)***keep frozen or refrigerated***consumer contact: produ...
Produce·0 affected·Aug 20, 2012
High RiskFDA
Abbott Vascular
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Surgical Devices·61,799 affected·Aug 20, 2012
High RiskFDA
Remel Inc
Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit i...
Diagnostic Devices·50 affected·Aug 20, 2012
High RiskFDA
Remel Inc
Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The ...
Diagnostic Devices·493 affected·Aug 20, 2012
High RiskFDA
Protica, Inc
ProBalance Protein To Go(TM), Caffeinated French Vanilla Latte, Dietary Supplement, Net Wt 2.5 fl oz (Responsible firm on labeling: Pr...
Supplements·230,000 affected·Aug 17, 2012
High RiskFDA
Protica, Inc
ProBalance Protein To Go(TM), Milk Chocolate Shake, Dietary Supplement, Net Wt 2.5 fl oz (Responsible firm on labeling: Pro Balance LLC...
Dairy·233,114 affected·Aug 17, 2012
High RiskFDA
Protica, Inc
Protein Shots, Orange Sunshine Flavor, 2.9 fl oz (Responsible firm on label: Body Choice Nutrition, Inc., 1595 Peachtree Park Way, Suite ...
Food·6,912 affected·Aug 17, 2012
High RiskFDA
Protica, Inc
Protein Wave 15 grams of protein, Tropical Fruit Gelatin (Responsible firm on label: Nutritional Resources, Inc., 5003 Wrightsboro Road,...
Produce·2,928 affected·Aug 17, 2012
High RiskFDA
Vital Signs Colorado Inc.
Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
Medical Devices·243,685 affected·Aug 17, 2012
High RiskFDA
Pastry Food Products Inc.
&TRIGAL***Empanadillas de Pizza (Pizza turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR&
Bakery & Grains·120 affected·Aug 16, 2012
High RiskFDA
Winn Dixie Stores, Inc.
Southern Home Cranberry Nut Antioxidant Blend, Trail Mix, Net Wt. 16oz. (1 LB) 454g, Distributed by Southern Home, P.O. Box 99, Mauldin, ...
Produce·232 affected·Aug 16, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121...
Diagnostic Devices·240 affected·Aug 16, 2012
High RiskFDA
Zoll Medical Corporation
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of co...
Cardiac Devices·11 affected·Aug 16, 2012
High RiskFDA
Blount Seafood Corporation
Wegman's Caribbean Black Bean Soup 16 oz retail cup Product Code: 85656
Food·143 affected·Aug 15, 2012
High RiskFDA
Blount Seafood Corporation
Wegman's Gazpacho Soup 16 oz retail cup Product Code: 85631
Food·233 affected·Aug 15, 2012
High RiskFDA
Blount Seafood Corporation
Wegman's Lobster Bisque 16 oz retail cup Product Code: 85630
Seafood·141 affected·Aug 15, 2012
High RiskFDA
Blount Seafood Corporation
Wegman's Tomato Basil with Orzo Soup 16 oz retail cup Product Code: 85653
Produce·143 affected·Aug 15, 2012
High RiskFDA
Philips Healthcare Inc.
Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. Th...
Medical Devices·2,314 affected·Aug 15, 2012
High RiskFDA
Surgical Specialties Puerto Rico Inc. Dba Angiotech Pr Inc.
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery
Surgical Devices·117,948 affected·Aug 15, 2012
High RiskFDA
Surgical Specialties Puerto Rico Inc. Dba Angiotech Pr Inc.
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
Surgical Devices·117,948 affected·Aug 15, 2012
High RiskFDA
Surgical Specialties Puerto Rico Inc. Dba Angiotech Pr Inc.
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery
Surgical Devices·117,948 affected·Aug 15, 2012
High RiskFDA
Sorin Group Usa, Inc.
Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
Medical Devices·1,125 affected·Aug 15, 2012
High RiskFDA
Pepsi Bottling Group Nashville
diet Orange Crush, no calorie orange soda, 2 L (2.1 QT), UPC 078000013979
Beverages·9,011 affected·Aug 14, 2012
High RiskFDA
Philips Healthcare Inc.
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Diagnostic Devices·4 affected·Aug 14, 2012
High RiskFDA
Lansinoh Laboratories Inc
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeu...
Medical Devices·51,472 affected·Aug 14, 2012
High RiskFDA
Atlantic Fisheries
Fresh Mahi Mahi Fillets,10 lb Styrofoam case, labeled in part: "***Mahi Fillets S/ON Costa Rica Wild****KEEP AT 38 OR BELOW Keep refriger...
Seafood·580 affected·Aug 13, 2012
High RiskFDA
Drucker Labs Lp
intraKID Lot 658 with a Best By date of 12/12, 33 oz and 2 oz bottles
Food·2,026 affected·Aug 13, 2012
High RiskFDA
Clif Bar And Company
Chocolate Chip CLIF Bars, 2.4-oz (68g), individually wrapped, UPC: 7-22252-10090
Snacks & Candy·4,608 affected·Aug 13, 2012
High RiskFDA
Clif Bar And Company
Blueberry Crisp CLIF Bars, 12 pack boxes, UPC: 7-22252-30260-1
Produce·384 affected·Aug 13, 2012
High RiskFDA
Vital Images, Inc.
Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 ...
Cardiac Devices·2,088 affected·Aug 13, 2012
High RiskFDA
Neomend Inc
Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated ...
Medical Devices·95 affected·Aug 13, 2012
High RiskFDA
Capsule Tech Inc.
Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docki...
Medical Devices·12,448 affected·Aug 10, 2012
High RiskFDA
Immunodiagnostics Systems Ltd
IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalc...
Diagnostic Devices·5 affected·Aug 10, 2012
High RiskFDA
Immunodiagnostics Systems Ltd
IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA Cr...
Diagnostic Devices·1 affected·Aug 10, 2012
High RiskFDA
Steris Corporation
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization pro...
Medical Devices·64 affected·Aug 10, 2012
High RiskFDA
Immunodiagnostics Systems Ltd
IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottle...
Diagnostic Devices·3 affected·Aug 10, 2012
High RiskFDA
Immunodiagnostics Systems Ltd
IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amin...
Diagnostic Devices·29 affected·Aug 10, 2012
High RiskFDA
Cefla Dental Group
MyRay RXDC dental unit x-ray unit
Medical Devices·173 affected·Aug 10, 2012
High RiskFDA
Spartan Central Kitchen
Spartan/Fresh Selections Wedge Sandwich W/Sandwich Spread 4oz
Food·288 affected·Aug 9, 2012
High RiskFDA
Tunnel Farms
Watermelon, labeled IT'S WATERMELON TIME!, Produce of USA, Seedless, #4032.
Beverages·7 affected·Aug 9, 2012
High RiskFDA
Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a pr...
Medical Devices·182 affected·Aug 9, 2012