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High RiskFDA
Oxysure Systems, Inc.
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Respiratory Devices·1,005 affected·Jun 12, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim compone...
Medical Devices·36,607 affected·Jun 12, 2015
High RiskFDA
Medtronic Perfusion Systems
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. ...
Medical Devices·1,304 affected·Jun 12, 2015
High RiskFDA
Justright Surgical, Llc
JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid. Product Usage: ...
Medical Devices·1,452 affected·Jun 11, 2015
High RiskFDA
Abbott Laboratories
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only....
Diagnostic Devices·5 affected·Jun 11, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, r...
Medical Devices·5 affected·Jun 11, 2015
High RiskFDA
The Harvard Drug Group, Llc
OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63...
Oral Drugs·12,717 affected·Jun 10, 2015
High RiskFDA
Vital Care Compounder
Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS
Drugs·54 affected·Jun 10, 2015
High RiskFDA
Vital Care Compounder
Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS
Drugs·39 affected·Jun 10, 2015
High RiskFDA
Astrazeneca Pharmaceuticals Lp
NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington...
Oral Drugs·34,524 affected·Jun 10, 2015
High RiskFDA
Vital Care Compounder
Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS
Injectable Drugs·9 affected·Jun 10, 2015
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
Medical Devices·12 affected·Jun 10, 2015
High RiskFDA
Northern Digital Inc.
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective mark...
Surgical Devices·524 affected·Jun 10, 2015
High RiskFDA
Alliance Partners Llc
Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended f...
Medical Devices·21 affected·Jun 9, 2015
High RiskFDA
Olympus Scientific Solutions Americas
Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-...
Medical Devices·1,047 affected·Jun 9, 2015
High RiskFDA
Life Science Pharmacy Inc
TRI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
ESTRIOL Vaginal Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
METHYLFOLATE Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Oral Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
ESTRIOL Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Oral Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
HUMAN CHORIONIC GONADOTROPIC (HCG) Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Injectable Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
BI-EST Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Topical Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
BI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
BI-EST Suspensions, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
BI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Oral Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
ESTRIOL Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Topical Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
METHYLFOLATE Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Injectable Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
HUMAN CHORIONIC GONADOTROPIC (HCG) Sublingual Drops, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
E3 CREAM, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Topical Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
ESTRIOL Vaginal Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Topical Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
ESTRIOL Suppositories, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
TRI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Oral Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
BI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
ESTRIOL Face Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Topical Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
2-DEOXY-D-GLUCOSE Powder, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
ESTRIOL Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
TRI-EST Liquids, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
TRI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Drugs·0 affected·Jun 8, 2015
High RiskFDA
Life Science Pharmacy Inc
HYDROXOCOBALAMIN Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Injectable Drugs·0 affected·Jun 8, 2015
High RiskFDA
Allergan Inc
Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (doubl...
Medical Implants·9 affected·Jun 8, 2015
High RiskFDA
Kraft Foods North America
CapriSun Variety Pack, with a multi colored plastic wrap with white and yellow lettering, covering 4 cartons. The 4 cartons consist of fr...
Beverages·1 affected·Jun 5, 2015
High RiskFDA
Cochlear Americas Inc.
Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile fiel...
Medical Implants·26 affected·Jun 5, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified...
Cardiac Devices·13,168 affected·Jun 5, 2015
High RiskFDA
Church & Dwight Inc
Gummy Vites Complete Multivitamin L'il Critters 70 gummies Manufactured for Church & Dwight Co., Inc. Ewing, NJ 08628
Supplements·3,360 affected·Jun 4, 2015
High RiskFDA
Fresenius Kabi Usa, Llc
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 6...
Injectable Drugs·7,593 affected·Jun 4, 2015
High RiskFDA
Panoramic Rental Corp.
Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the ...
Medical Devices·7,885 affected·Jun 4, 2015
High RiskFDA
Biomet, Inc.
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in th...
Medical Devices·75 affected·Jun 4, 2015
High RiskFDA
Gardner Denver Thomas Inc
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator
Medical Devices·508 affected·Jun 4, 2015
High RiskFDA
Biomet, Inc.
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Medical Devices·50 affected·Jun 4, 2015