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High RiskFDA
Boston Scientific Crm Corp
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models ...
Medical Implants·31,144 affected·Sep 17, 2014
High RiskFDA
Boston Scientific Crm Corp
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not availabl...
Cardiac Devices·31,144 affected·Sep 17, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for s...
Cardiac Devices·44 affected·Sep 17, 2014
High RiskFDA
Nordicneurolab As
nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties an...
Medical Devices·22 affected·Sep 17, 2014
High RiskFDA
Bio-detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage...
Cardiac Devices·41 affected·Sep 16, 2014
High RiskFDA
Bio-detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE El...
Cardiac Devices·193 affected·Sep 16, 2014
High RiskFDA
Bio-detek, Inc.
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connec...
Cardiac Devices·237 affected·Sep 16, 2014
High RiskFDA
Astellas Pharma Us Inc
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC...
Oral Drugs·9,236 affected·Sep 15, 2014
High RiskFDA
Zydus Pharmaceuticals Usa Inc
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Phar...
Oral Drugs·14,568 affected·Sep 15, 2014
High RiskFDA
American Family Pharmacy, Llc
Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbri...
Oral Drugs·4,207,200 affected·Sep 15, 2014
High RiskFDA
Abbvie Inc
CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chi...
Oral Drugs·18,021 affected·Sep 15, 2014
High RiskFDA
Codman & Shurtleff, Inc.
Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospi...
Surgical Devices·1,145 affected·Sep 15, 2014
High RiskFDA
Arrow International Inc
ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
Surgical Devices·300 affected·Sep 15, 2014
High RiskFDA
Ge Oec Medical Systems, Inc
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Surgical Devices·61 affected·Sep 15, 2014
High RiskFDA
Codman & Shurtleff, Inc.
Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cereb...
Surgical Devices·93,558 affected·Sep 15, 2014
High RiskFDA
Ge Oec Medical Systems, Inc
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Surgical Devices·61 affected·Sep 15, 2014
High RiskFDA
Invivo Corporation
Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Ex...
Medical Devices·639 affected·Sep 14, 2014
High RiskFDA
Mckesson
Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford,...
Injectable Drugs·10 affected·Sep 12, 2014
High RiskFDA
Eyemart Express Ltd
Prescription eyeglass safety lenses. Vision correction
Medical Devices·76 affected·Sep 12, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectiona...
Medical Devices·79 affected·Sep 11, 2014
High RiskFDA
The Binding Site Group, Ltd.
Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 ...
Medical Devices·0 affected·Sep 11, 2014
High RiskFDA
The Binding Site Group, Ltd.
Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917...
Diagnostic Devices·0 affected·Sep 11, 2014
High RiskFDA
The Binding Site Group, Ltd.
MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunog...
Medical Devices·0 affected·Sep 11, 2014
High RiskFDA
The Binding Site Group, Ltd.
Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human ...
Medical Devices·0 affected·Sep 11, 2014
High RiskFDA
Intuitive Surgical, Inc.
ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instru...
Cardiac Devices·75 affected·Sep 11, 2014
High RiskFDA
The Binding Site Group, Ltd.
Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG subclasses ...
Diagnostic Devices·0 affected·Sep 11, 2014
High RiskFDA
Abbott Ireland Diagnostics Division
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES b...
Diagnostic Devices·7,415 affected·Sep 11, 2014
High RiskFDA
Intertrade Imports Inc.
Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, ...
Medical Devices·750 affected·Sep 10, 2014
High RiskFDA
Hospira Inc.
Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Int...
Injectable Drugs·373,180 affected·Sep 9, 2014
High RiskFDA
Zimmer, Inc.
Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.
Medical Devices·16,380 affected·Sep 9, 2014
High RiskFDA
Blue Diamond Growers
Natural Blue Diamond Almonds Artisan Nut-Thins crafted with brown rice, almonds & Chia Seeds Wheat & Gluten free Net wt. 4.25 oz. Box. ...
Bakery & Grains·1,843 affected·Sep 8, 2014
High RiskFDA
Baxter Healthcare Corp
Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Bax...
Injectable Drugs·148,632 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold u...
Surgical Devices·2 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries,...
Surgical Devices·81 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold und...
Medical Devices·3 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or di...
Surgical Devices·190 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on ...
Surgical Devices·5 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Sy...
Surgical Devices·26 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known forc...
Surgical Devices·3 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medl...
Surgical Devices·421 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping ...
Surgical Devices·26 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold u...
Surgical Devices·4 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold un...
Medical Devices·13 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fra...
Medical Devices·2 affected·Sep 8, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is in...
Diagnostic Devices·97 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under...
Medical Devices·5 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold u...
Surgical Devices·9 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under...
Surgical Devices·790 affected·Sep 8, 2014