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High RiskFDA
Siemens Healthcare Diagnostics, Inc.
RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing t...
Diabetes Devices·138 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications in...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging app...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applica...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging appl...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Roche Diagnostics Corporation
Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled full...
Medical Devices·12 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applica...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications i...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applic...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applic...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console...
Surgical Devices·1,014 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging appl...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Valeris Medical, Llc
Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid...
Medical Devices·75 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applic...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imagin...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
In2bones Usa, Llc
CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating Syste...
Medical Devices·47 affected·Jul 16, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality...
Diabetes Devices·10,199 affected·Jul 16, 2018
High RiskFDA
Aldi Inc
AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits
Food·0 affected·Jul 14, 2018
High RiskFDA
Aldi Inc
AnnaSea Limu Ahi Poke Hawaiian Poke Kits
Food·0 affected·Jul 14, 2018
High RiskFDA
The Coca-cola Company
Odwalla Superfood fruit smoothie 15.2 oz. (450mL) plastic bottle; Sold in 8 pack case Unit UPC: 000-14054-06405-5 Odwalla Life Food-...
Beverages·14,870 affected·Jul 13, 2018
High RiskFDA
Prinston Pharmaceutical Inc
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Hua...
Oral Drugs·0 affected·Jul 13, 2018
High RiskFDA
Prinston Pharmaceutical Inc
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Hu...
Oral Drugs·0 affected·Jul 13, 2018
High RiskFDA
Prinston Pharmaceutical Inc
Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xy...
Oral Drugs·0 affected·Jul 13, 2018
High RiskFDA
Prinston Pharmaceutical Inc
Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xy...
Oral Drugs·0 affected·Jul 13, 2018
High RiskFDA
Prinston Pharmaceutical Inc
Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. ...
Oral Drugs·0 affected·Jul 13, 2018
High RiskFDA
Prinston Pharmaceutical Inc
Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. ...
Oral Drugs·0 affected·Jul 13, 2018
High RiskFDA
Prinston Pharmaceutical Inc
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang H...
Oral Drugs·0 affected·Jul 13, 2018
High RiskFDA
Prinston Pharmaceutical Inc
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang ...
Oral Drugs·0 affected·Jul 13, 2018
High RiskFDA
Prinston Pharmaceutical Inc
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang H...
Oral Drugs·0 affected·Jul 13, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 86...
Medical Devices·96,324 affected·Jul 13, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients...
Cardiac Devices·96,324 affected·Jul 13, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professional...
Medical Devices·96,324 affected·Jul 13, 2018
High RiskFDA
Haemonetics Corporation
Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicate...
Surgical Devices·432 affected·Jul 13, 2018
High RiskFDA
Kerr/pentron, Dba Kerr Corporation And Pentron Clinical
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Medical Devices·31,904 affected·Jul 13, 2018
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Pro...
Medical Devices·40 affected·Jul 13, 2018
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Prod...
Medical Devices·80 affected·Jul 13, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by he...
Medical Devices·96,324 affected·Jul 13, 2018
High RiskFDA
Tosoh Bioscience Inc
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in who...
Diabetes Devices·8 affected·Jul 13, 2018
High RiskFDA
Exactech, Inc.
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Medical Devices·7 affected·Jul 13, 2018
High RiskFDA
J And J Bunting, Inc
Kowalski's Markets kalbi rub. Net Wt 5.5 oz. (155.9 g), UPC 79147-00243. Distributed by: Kowalski's Markets, Woodbury, MN 55125
Food·117 affected·Jul 12, 2018
High RiskFDA
Kerry Inc
Soy Honey Cluster 30 lb. case, plastic bag in cardboard box Product code 30666529.137
Food·165,600 affected·Jul 12, 2018
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ...
Injectable Drugs·5,215 affected·Jul 12, 2018
High RiskFDA
Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
Medical Devices·41 affected·Jul 12, 2018
High RiskFDA
Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
Medical Devices·68 affected·Jul 12, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Diagnostic Devices·7,880 affected·Jul 12, 2018
High RiskFDA
Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
Medical Devices·37 affected·Jul 12, 2018
High RiskFDA
Zimmer Biomet, Inc.
Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone frag...
Medical Devices·25 affected·Jul 12, 2018