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High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·1 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only*** This device is intended to be used with ...
Medical Devices·10 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used ...
Medical Devices·40 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used ...
Medical Devices·20 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·3 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·50 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is intended to be used with Anspach...
Medical Devices·1 affected·Nov 28, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
Medical Devices·896 affected·Nov 27, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Diagnostic Devices·2,976 affected·Nov 27, 2012
High RiskFDA
Arrow International Inc
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilize...
Surgical Devices·188 affected·Nov 27, 2012
High RiskFDA
Perkinelmer
NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for th...
Medical Devices·3,029 affected·Nov 26, 2012
High RiskFDA
Dako Denmark A/s
CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic...
Medical Devices·25 affected·Nov 26, 2012
High RiskFDA
Perkinelmer
DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
Medical Devices·56 affected·Nov 26, 2012
High RiskFDA
Taro Pharmaceuticals U.s.a., Inc.
Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: ...
Topical Drugs·39,982 affected·Nov 21, 2012
High RiskFDA
Hospira, Inc.
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
Injectable Drugs·145,400 affected·Nov 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary b...
Medical Devices·5,760 affected·Nov 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmona...
Medical Devices·5,760 affected·Nov 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmona...
Medical Devices·5,760 affected·Nov 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary b...
Medical Devices·5,760 affected·Nov 21, 2012
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine ...
Diabetes Devices·1,130 affected·Nov 21, 2012
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices place...
Medical Devices·134 affected·Nov 21, 2012
High RiskFDA
Upsher Smith Laboratories, Inc.
Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc M...
Oral Drugs·60 affected·Nov 20, 2012
High RiskFDA
Ge Healthcare It
Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support...
Medical Devices·17 affected·Nov 20, 2012
High RiskFDA
Conmed Corporation
WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. ...
Medical Devices·452 affected·Nov 20, 2012
High RiskFDA
Zimmer, Inc.
COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET...
Medical Devices·23 affected·Nov 19, 2012
High RiskFDA
Biohorizons Implant Systems Inc
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
Medical Devices·174 affected·Nov 19, 2012
High RiskFDA
Focus Products Group Llc
Cocoa~Latte Hot Drink Maker; an electric hot drink mixer and dispenser with a 32 fl.oz. heating and mixing jar, twist and lock lid, "perf...
Beverages·568,000 affected·Nov 17, 2012
High RiskFDA
Cho Fuku Group (usa) Inc
Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune), 5 oz (142g)
Snacks & Candy·430 affected·Nov 16, 2012
High RiskFDA
Abbott Laboratories, Inc
Clinical Chemistry Phenobarbital, list number 1E08
Medical Devices·1,289 affected·Nov 16, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortica...
Medical Devices·20 affected·Nov 16, 2012
High RiskFDA
Ge Healthcare It
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators...
Medical Devices·1,379 affected·Nov 16, 2012
High RiskFDA
Arjo, Inc. Dba Arjohuntleigh
Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8...
Medical Devices·94 affected·Nov 16, 2012
High RiskFDA
Bakery Cash & Carry Inc.
Brandy flavor
Food·3,360 affected·Nov 15, 2012
High RiskFDA
Bakery Cash & Carry Inc.
Butter Flavor
Dairy·0 affected·Nov 15, 2012
High RiskFDA
Bakery Cash & Carry Inc.
Butter Cream
Dairy·3,360 affected·Nov 15, 2012
High RiskFDA
Physicians Total Care, Inc.
Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & distributed by: Physicians Total Care, Inc....
Oral Drugs·90 affected·Nov 15, 2012
High RiskFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL ...
Injectable Drugs·273,925 affected·Nov 15, 2012
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
Surgical Devices·8 affected·Nov 15, 2012
High RiskFDA
Ge Healthcare It
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagno...
Diagnostic Devices·498 affected·Nov 15, 2012
High RiskFDA
Viterion Telehealthcare Llc
Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detec...
Medical Devices·7,698 affected·Nov 15, 2012
High RiskFDA
Eeg Info
EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
Medical Devices·1,308 affected·Nov 15, 2012
High RiskFDA
Biomet, Inc.
Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for ap...
Medical Implants·200 affected·Nov 15, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 ...
Diagnostic Devices·100 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile, This device is used with the Persona Knee S...
Medical Devices·93 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT Th...
Medical Devices·318 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F Right This device is used with...
Medical Devices·188 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGH...
Medical Devices·195 affected·Nov 14, 2012
High RiskFDA
Leica Microsystems, Inc.
Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for...
Diagnostic Devices·322 affected·Nov 14, 2012