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High RiskFDA
Ge Healthcare, Llc
GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging an...
Cardiac Devices·710 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TR...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Becton Dickinson & Co.
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc...
Diagnostic Devices·33 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NE...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
HGP II ACETABULAR CUP MOD
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
HGP II ACETABULAR CUP BON
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
6 DEGREE COCR FEM HEAD 36
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR ...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended ...
Medical Devices·9 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Prothera, Inc.
Klaire Labs Interfase; Enzyme Supplement; Packaged in 60 and 120 Vegetarian capsules bottles. UPC 60 ct.- 7 0961 012270 7; UPc 120...
Supplements·243,851 affected·Oct 10, 2013
High RiskFDA
Prothera, Inc.
Klaire Labs Vital-Zymes Chewable; Comprehensive Enzyme Supplement; 180 Chewable tablets. UPC 7 09616 0218 5 Manufactured by ProTh...
Supplements·82,746 affected·Oct 10, 2013
High RiskFDA
Prothera, Inc.
Klaire Labs Interfase Plus; Enzyme Supplement; 120 Vegetarian capsules bottles. UPC 7 09616 01228 4 Manufactured by ProThera, I...
Supplements·0 affected·Oct 10, 2013
High RiskFDA
Prothera, Inc.
Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled UPC - 90 count: 8 28054 00542 6 UPC- 180 count 8 28054 00149 7; ...
Supplements·27,480 affected·Oct 10, 2013
High RiskFDA
Nutrition Center, Inc. Dba Nutri-west
Total Enzyme, Dietary Supplement, Nutri-West, 120 capsules, Servicing Size 1 Capsule
Supplements·8,414 affected·Oct 10, 2013
High RiskFDA
Prothera, Inc.
Klaire Labs Vital-Zymes complete; Comprehensive Enzyme Supplement; 120 Vegetarian tablets. UPC 790616310005 Manufactured by ProTh...
Supplements·187,941 affected·Oct 10, 2013
High RiskFDA
Nutrition Center, Inc. Dba Nutri-west
Total Probiotics, Dietary Supplement, Nutri-West, 50 Capsules, Servicing Size 1 Capsule
Supplements·13,864 affected·Oct 10, 2013
High RiskFDA
Airgas Medical Services
Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Mer...
Drugs·145 affected·Oct 10, 2013
High RiskFDA
Cayenne Medical Inc.
Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro...
Medical Devices·229 affected·Oct 10, 2013
High RiskFDA
Nova Biomedical Corporation
Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital...
Diabetes Devices·200,000 affected·Oct 10, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of...
Medical Devices·220 affected·Oct 10, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a dispo...
Medical Devices·6,380 affected·Oct 10, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended ...
Respiratory Devices·780 affected·Oct 10, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
VariAx Compression Plating System
Medical Devices·118 affected·Oct 10, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection...
Diagnostic Devices·80 affected·Oct 10, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitativ...
Diagnostic Devices·400 affected·Oct 10, 2013
High RiskFDA
Actavis Elizabeth Llc
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4...
Oral Drugs·756 affected·Oct 9, 2013
High RiskFDA
Sandoz, Inc
Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Prince...
Oral Drugs·692 affected·Oct 9, 2013
High RiskFDA
Neurotherm, Inc.
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Medical Devices·25 affected·Oct 9, 2013
High RiskFDA
Arrow International Inc
Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of cat...
Surgical Devices·121 affected·Oct 9, 2013
High RiskFDA
Arrow International Inc
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices in...
Diagnostic Devices·294,430 affected·Oct 9, 2013
High RiskFDA
Zimmer, Inc.
Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a tempo...
Medical Implants·94 affected·Oct 9, 2013
High RiskFDA
Ge Healthcare, Llc
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by compute...
Medical Devices·272 affected·Oct 9, 2013
High RiskFDA
Krispak Inc
Good Sense Spicy Sweet Mix, 25-oz (1lb 9oz) plastic container, UPC: 030243787178
Food·315 affected·Oct 8, 2013
High RiskFDA
Quaker Foods And Snacks North America
White grits packaged in a paper bag labeled in part: Smooth & Creamy; Aunt Jemima; Quick GRITS; Cooks in about 5 minutes; ENRICHED WHITE ...
Food·2,720 affected·Oct 8, 2013
High RiskFDA
Quaker Foods And Snacks North America
White grits packaged in a paper bag labeled in part: Smooth & Creamy; Aunt Jemima; Quick GRITS; Cooks in about 5 minutes; ENRICHED WHITE ...
Food·2,720 affected·Oct 8, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for...
Medical Implants·548 affected·Oct 8, 2013
High RiskFDA
Cgnp Manufacturing
Beachbody Optimize Enzymes Capusles, 126 CT, 8 oz. Container size: JAR 8OZ WHITE 70MM NECK POLYPROPYLENE...
Supplements·500 affected·Oct 7, 2013
High RiskFDA
Kellogg Canada Corporate Office
Pringles(R) SALT & VINEGAR Potato Chips, 168 g (UPC 064100852464) and 181 g (UPC 037000230090), Pringles Manufacturing Company, 1306 High...
Snacks & Candy·182 affected·Oct 7, 2013
High RiskFDA
Amedra Pharmaceuticals Llc
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pha...
Oral Drugs·10,992 affected·Oct 7, 2013
High RiskFDA
Betachem, Inc.
Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, ...
Drugs·27,000 affected·Oct 7, 2013
High RiskFDA
Rti Surgical, Inc.
C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devic...
Medical Implants·1,906 affected·Oct 7, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
Medical Devices·4 affected·Oct 7, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower Us...
Diagnostic Devices·2,038 affected·Oct 7, 2013
High RiskFDA
Lap Of America Laser Applications, Llc
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient a...
Medical Devices·280 affected·Oct 7, 2013