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High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012242
Surgical Devices·240 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393420, 14.5F, Straight, 42cm length, BARD, UDI: 00801...
Surgical Devices·713 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 00801...
Surgical Devices·1,679 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve, 28cm length, BARD, UDI: 00801741012266
Surgical Devices·104 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight ,23cm length, BARD, UDI: 00801...
Surgical Devices·1,731 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801...
Surgical Devices·899 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD,...
Surgical Devices·34 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 00801...
Surgical Devices·140 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00...
Surgical Devices·100 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012259
Surgical Devices·570 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD,...
Surgical Devices·135 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00...
Surgical Devices·455 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight ,27cm length, BARD, UDI: 00801...
Surgical Devices·39 affected·May 31, 2019
High RiskFDA
Stonyfield Farm
Strawberry Banana Smoothie, 3.1oz, 6 pack, UPC Code 52159-70082
Beverages·5,148 affected·May 30, 2019
High RiskFDA
Surgery Pharmacy Services Inc
Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., C...
Drugs·1,149 affected·May 30, 2019
High RiskFDA
Surgery Pharmacy Services Inc
Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.A...
Drugs·84 affected·May 30, 2019
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Medical Implants·167 affected·May 30, 2019
High RiskFDA
Ortho Development Corporation
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Medical Devices·27 affected·May 30, 2019
High RiskFDA
Medline Industries, Inc.
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP C...
Cardiac Devices·14,550 affected·May 30, 2019
High RiskFDA
Boston Scientific Neuromodulation Corporation
Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tiss...
Medical Devices·43 affected·May 30, 2019
CriticalFDA
Galemed Corporation
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Medical Devices·12,000 affected·May 30, 2019
High RiskFDA
Clinical Innovations, Llc
Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Man...
Medical Devices·280 affected·May 30, 2019
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Pr...
Medical Devices·360 affected·May 29, 2019
High RiskFDA
Siemens Healthcare Diagnostics Inc
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in...
Cardiac Devices·2,312 affected·May 29, 2019
High RiskFDA
Nexagen, Llc
ACID RAIN ASS KICKING FAT DESTROYER APOCALYPSE LABZ; 45 CAPSULES; 1 DIETARY SUPPLEMENT; UPC 6 11138 28792 0
Supplements·157 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.
Injectable Drugs·68 affected·May 28, 2019
CriticalFDA
Novis Pr, Inc.
Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol Free, Dye Free, Gluten...
Drugs·5,766 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Injectable Drugs·82 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Injectable Drugs·0 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Injectable Drugs·35 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Injectable Drugs·20 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Injectable Drugs·45 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
Injectable Drugs·20 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.
Injectable Drugs·3 affected·May 28, 2019
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
Surgical Devices·10 affected·May 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography syste...
Medical Devices·9 affected·May 28, 2019
High RiskFDA
Zimmer Biomet, Inc.
DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitat...
Medical Implants·3,022 affected·May 28, 2019
High RiskFDA
Medline Industries Inc
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular devic...
Surgical Devices·0 affected·May 28, 2019
High RiskFDA
Medline Industries Inc
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular dev...
Surgical Devices·330 affected·May 28, 2019
High RiskFDA
Zimmer Biomet, Inc.
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate...
Medical Implants·3,022 affected·May 28, 2019
High RiskFDA
Zimmer Biomet, Inc.
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantatio...
Medical Implants·3,022 affected·May 28, 2019
High RiskFDA
Gn Otometrics
The ICS CHARTR EP 200
Medical Devices·3,071 affected·May 28, 2019
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
Surgical Devices·11 affected·May 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography sy...
Medical Devices·24 affected·May 28, 2019
High RiskFDA
Bio-detek, Inc.
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Medical Devices·1,789 affected·May 28, 2019
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
Surgical Devices·2 affected·May 28, 2019
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
Surgical Devices·7 affected·May 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography sys...
Medical Devices·30 affected·May 28, 2019