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High RiskFDA
Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a pr...
Medical Devices·270 affected·Aug 9, 2012
High RiskFDA
Stryker Spine
SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis ...
Medical Devices·28 affected·Aug 9, 2012
High RiskFDA
Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a pr...
Medical Devices·286 affected·Aug 9, 2012
High RiskFDA
Stryker Spine
Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.3...
Medical Devices·19 affected·Aug 9, 2012
High RiskFDA
Applied Medical Resources Corp
Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BI...
Surgical Devices·40,238 affected·Aug 9, 2012
High RiskFDA
Agfa Corp.
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image ...
Medical Devices·535 affected·Aug 9, 2012
High RiskFDA
Shin Shin Foods, Inc.
Yogurt Parfait Strawberry, Net weight 9 oz. (225 g), UPC 0 20728 70004 4. Product contains yogurt and strawberry filling and one cup of g...
Dairy·300 affected·Aug 8, 2012
High RiskFDA
Lucky Country, Inc.
Aussie-Style Lucky Country Soft Licorice in 1.5 lb. bags. The product is packaged 1.5lb x 18 bags per tray.
Food·1,577 affected·Aug 8, 2012
High RiskFDA
American Importing Co, Inc
Nature's Harvest, pine nuts, Net WT 3 oz (85 g), Distributed by Amport Foods, 550 Kasota Ave, SE., Minneapolis, MN 55414, 3 00 71725 7275...
Food·5,441 affected·Aug 8, 2012
High RiskFDA
Parks Medical Electronics, Inc
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices a...
Medical Devices·349 affected·Aug 8, 2012
High RiskFDA
Zoll Circulation, Inc.
AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Ches...
Medical Devices·3,881 affected·Aug 8, 2012
High RiskFDA
Karl Bissinger Inc
Bissinger's Campfire S'Mores Salt Caramels, packaged in 1.8-oz. boxes, 5 pieces per box, 12 boxes per display case, UPC 846107012788. Th...
Food·80 affected·Aug 7, 2012
High RiskFDA
Atlas Operations, Inc.
Meal Replacement product is labeled in part: "***The Perfect Shake***All of the Best***None of the Rest***foru***Dietary supplement***Ne...
Dairy·425 affected·Aug 7, 2012
High RiskFDA
Ernesto Tropical Food, Inc
"Sofrito a Mi Gusto***100% Natural (Natural Seasoning)***Keep Refrigerated***Elaborado y Envasado por Ernesto Tropical Foods, Inc. Guadal...
Food·576 affected·Aug 7, 2012
High RiskFDA
Ernesto Tropical Food, Inc
"Recaito Do¿a Tita***Home Made Style***Keep Refrigerated***Elaborado y Envasado por Ernesto Tropical Foods, Inc. Guadalupe #62, Ponce PR ...
Food·528 affected·Aug 7, 2012
High RiskFDA
Pal-do Company, Inc D.b.a. Pal-do World
Frozen fermented seasoned oysters, bulk packaged 22 lbs per case.
Seafood·440 affected·Aug 7, 2012
High RiskFDA
Mylan Pharmaceuticals Inc.
Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***...
Oral Drugs·24,331 affected·Aug 7, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to trea...
Medical Devices·100 affected·Aug 6, 2012
High RiskFDA
Thyssenkrupp Access Corp
ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up an...
Medical Devices·5,413 affected·Aug 6, 2012
High RiskFDA
Diamedix Corporation
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the...
Diagnostic Devices·65 affected·Aug 6, 2012
High RiskFDA
Orthofix, Inc
Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the ...
Medical Devices·1,224 affected·Aug 6, 2012
High RiskFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 6004...
Injectable Drugs·56,420 affected·Aug 3, 2012
High RiskFDA
Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed spec...
Diagnostic Devices·1,074 affected·Aug 3, 2012
High RiskFDA
Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed s...
Diagnostic Devices·140 affected·Aug 3, 2012
High RiskFDA
Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specif...
Diagnostic Devices·562 affected·Aug 3, 2012
High RiskFDA
Biomet 3i, Llc
Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or ...
Medical Implants·227 affected·Aug 3, 2012
High RiskFDA
Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed s...
Diagnostic Devices·46 affected·Aug 3, 2012
High RiskFDA
Covidien Llc
HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex E...
Medical Devices·617 affected·Aug 3, 2012
High RiskFDA
Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifi...
Diagnostic Devices·304 affected·Aug 3, 2012
High RiskFDA
Medical Specialties Distributors, Inc.
Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialtie...
Medical Devices·472 affected·Aug 3, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and di...
Medical Devices·126 affected·Aug 3, 2012
High RiskFDA
Hospira, Inc.
Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a c...
Medical Devices·0 affected·Aug 2, 2012
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC...
Oral Drugs·48 affected·Aug 1, 2012
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, ND...
Oral Drugs·27,805 affected·Aug 1, 2012
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC...
Oral Drugs·86 affected·Aug 1, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, ...
Diagnostic Devices·217 affected·Aug 1, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Op...
Diagnostic Devices·217 affected·Aug 1, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, ...
Diagnostic Devices·217 affected·Aug 1, 2012
High RiskFDA
Four Brothers Packaging Corporation
Jakes Spice Drop, Jake's Jelly Spice Drops 3oz, 4.5oz, 5oz, 6oz and 7oz packages Distributed by Jake's Liberty Packaging Oak Park, MI 48...
Food·0 affected·Jul 31, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phe...
Diagnostic Devices·79,744 affected·Jul 30, 2012
High RiskFDA
Imaging Sciences International, Llc
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Medical Devices·366 affected·Jul 30, 2012
High RiskFDA
Tomales Bay Foods, Inc.
Tomales Bay Foods brand Artisan Cheese in PARTIAL WHEELS of Cheese, from cheese makers in US (VA, VT, Ca, WI, OR, WA and UT) and Irelan...
Dairy·562 affected·Jul 28, 2012
High RiskFDA
Apio, Inc. Dba Apio Fresh Llc
Fresh Select Brussels Sprouts, 6x8oz, 9x12oz. Item # 22986, 22707, UPC 0 11110 91610 5, 7 09351 32222 8.
Food·236 affected·Jul 27, 2012
High RiskFDA
Apio, Inc. Dba Apio Fresh Llc
Eat Smart Broccoli & Cauliflower, 9x12oz. Item # 10068. Code Dates: B07208, B08208.
Food·22 affected·Jul 27, 2012
High RiskFDA
Apio, Inc. Dba Apio Fresh Llc
Eat Smart Snap Peas, 14x2lbs, 6x8oz , 12x8oz. Item # 18786, 22216, 10094, UPC 7 09351 00035 5, 7 09351 00901 3
Food·1,618 affected·Jul 27, 2012
High RiskFDA
Capco Custom Packaging Inc
Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (23...
Oral Drugs·14,380 affected·Jul 27, 2012
High RiskFDA
Mylan Pharmaceuticals Inc.
Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC ...
Oral Drugs·960 affected·Jul 27, 2012
High RiskFDA
Nipro Medical Corporation
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic p...
Surgical Devices·300 affected·Jul 27, 2012