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High RiskFDA
Eb5 Corporation
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Man...
Topical Drugs·4,632 affected·Jun 22, 2018
High RiskFDA
Akorn, Inc.
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
Injectable Drugs·89,507 affected·Jun 22, 2018
High RiskFDA
Smiths Medical Asd Inc.
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Ele...
Medical Devices·28,578,939 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgi...
Surgical Devices·385 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure P...
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Smiths Medical Asd Inc.
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-...
Medical Devices·28,578,939 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography system...
Cardiac Devices·605 affected·Jun 22, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-wa...
Surgical Devices·92,150 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Product Usage: This is sterile, single use...
Surgical Devices·1,000 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK;...
Medical Devices·372 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage: This is sterile, single use, two-way silicone ...
Surgical Devices·500 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·16,133 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronizati...
Medical Implants·1,842 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchron...
Medical Implants·3,560 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt lmbwool; 54580...
Medical Devices·381 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices·2,461 affected·Jun 21, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectru...
Medical Devices·158 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices·34,627 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/...
Medical Devices·656 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY Product Usage: This is sterile, single use, two-way...
Surgical Devices·4,332 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB ...
Medical Devices·342 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK; 516DS/ Skull Pin 3in CT Sterl 1...
Medical Devices·824 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone ...
Surgical Devices·250 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use...
Surgical Devices·500 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage: This is sterile, single use, two-way silicone ...
Surgical Devices·5,000 affected·Jun 21, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Medical Devices·0 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·16,350 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchron...
Medical Implants·6,712 affected·Jun 21, 2018
High RiskFDA
Becton Dickinson & Co.
BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae...
Medical Devices·10,360 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices·11,488 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is sterile, single use, two-way silicone Fol...
Surgical Devices·330 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices·1,000 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley C...
Surgical Devices·1,588 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices·14,326 affected·Jun 21, 2018
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153...
Medical Implants·103 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML...
Medical Devices·138 affected·Jun 21, 2018