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High RiskFDA
Gsk Consumer Healthcare
Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline...
Drugs·56,840 affected·Mar 6, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, comm...
Medical Devices·104 affected·Mar 6, 2017
High RiskFDA
Tradewind Foods De Puerto Rico Inc.
Goya Octopus in Pickled Sauce, Pulpo a la Marinera, NET WT./PESO NETO 4 oz. (113g), PRODUCT OF SPAIN "WILD FISH", GOYA FOODS, INC., Secau...
Seafood·800 affected·Mar 3, 2017
High RiskFDA
Tradewind Foods De Puerto Rico Inc.
Goya Octopus in Vegetable Oil, Pulpo en Aceite Vegetal, NET WT./PESO NETO 4 oz. (113g), PRODUCT OF SPAIN "WILD FISH", GOYA FOODS, INC., S...
Seafood·1,551 affected·Mar 3, 2017
High RiskFDA
Tradewind Foods De Puerto Rico Inc.
Goya Octopus in Garlic Sauce, Pulpo al Ajillo, NET WT./PESO NETO 4 oz. (113g), PRODUCT OF SPAIN "WILD FISH", GOYA FOODS, INC., Secaucus N...
Seafood·1,325 affected·Mar 3, 2017
High RiskFDA
Tradewind Foods De Puerto Rico Inc.
Goya Octopus in Hot Sauce, Pulpo en Salsa Picante, NET WT./PESO NETO 4 oz. (113g), PRODUCT OF SPAIN "WILD FISH", GOYA FOODS, INC., Secauc...
Seafood·515 affected·Mar 3, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-u...
Medical Implants·124 affected·Mar 3, 2017
High RiskFDA
Covidien Llc
Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 2...
Medical Devices·104,688 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, STERILE, Rx Only Product Usage: The LaserEdge Knives are...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, STERILE, Rx Only Product Usage: The LaserEdge Knives are...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7529, STERILE, Rx Only Product Usage: The Laser...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Covidien Llc
Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gau...
Medical Devices·1,659,500 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB, STERILE, Rx Only Product Usage: The LaserEdge Kni...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7551ADB, STERILE, Rx Only Product Usage: The Lase...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510, STERILE, Rx Only Product Usage: The LaserEdge Kn...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 30 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7530T, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED (6/BOX), REF/PRODUCT CODE E7551ADBG, STERILE, Rx Only Product Usage: ...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 20 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7520, STERILE, Rx Only Product Usage: The LaserEdge Knives are inten...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT CODE E7510AT, STERILE, Rx Only Product Usage: The LaserEdge ...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Arrow International Inc
The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
Surgical Devices·1,351 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7552ADB, STERILE, Rx Only Product Usage: The Laser...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, STERILE, Rx Only Product Usage: The LaserEdge Knives are i...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Integra Lifesciences Corp.
Panta Nail, Rx only, Sterile,
Medical Devices·4,449 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.85MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7553A, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, STERILE, Rx Only Product Usage: The LaserEdge Knives...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only Product Usage: The LaserEd...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Covidien Llc
Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gau...
Medical Devices·7,168,000 affected·Mar 3, 2017
High RiskFDA
Verathon Inc
It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Pa...
Medical Devices·292 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556A, STERILE, Rx Only Product Usage: The LaserEd...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.5 MM SLIT KNIFE BEVEL UP ANGLED GUARDED(6/BOX), REF/PRODUCT CODE E7550AG, STERILE, Rx Only Product Usage: The La...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.6 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7550ADB, STERILE, Rx Only Product Usage: The Lase...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Covidien Llc
Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20...
Medical Devices·1,222,080 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, KNIFE ANGLED BEVELED UP 2.7(6/BOX), REF/PRODUCT CODE E7559A, STERILE, Rx Only Product Usage: The LaserEdge Knives ...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.9MM (6/BOX), REF/PRODUCT CODE E7587A, STERILE, Rx Only Product Usage: The LaserEdge Knives ...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Merit Medical Systems, Inc.
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis...
Surgical Devices·1,940 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 30 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7530, STERILE, Rx Only Product Usage: The LaserEdge Knives are int...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE E7551AG, STERILE, Rx Only Product Usage: The L...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 4.0MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7560A, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Implants·1,236,749 affected·Mar 3, 2017
High RiskFDA
Fougera Pharmaceuticals Inc.
Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New Yor...
Topical Drugs·14,665 affected·Mar 2, 2017
High RiskFDA
Ortho Kinematics, Inc
Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intend...
Medical Devices·1 affected·Mar 2, 2017
High RiskFDA
Myelotec, Inc.
Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
Surgical Devices·2,980 affected·Mar 2, 2017
High RiskFDA
Signature Club A Ltd
Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%, Oxybenzone 6.18%, Octisalate...
Topical Drugs·1,237 affected·Mar 1, 2017
High RiskFDA
Inion Ltd.
Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the r...
Medical Implants·36 affected·Mar 1, 2017
High RiskFDA
Roche Diagnostics Corporation
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Medical Devices·45 affected·Mar 1, 2017