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High RiskFDA
Paddock Laboratories, Llc.
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneap...
Inhaled / Nasal Drugs·52,596 affected·Feb 26, 2018
High RiskFDA
Beaver-visitec International Inc.
Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Medical Devices·1,025 affected·Feb 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Diagnostic Devices·0 affected·Feb 26, 2018
High RiskFDA
Beaver-visitec International Inc.
WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that ...
Medical Devices·110 affected·Feb 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
Diagnostic Devices·0 affected·Feb 26, 2018
High RiskFDA
Preservation Solutions, Inc.
Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Ca...
Medical Devices·31,104 affected·Feb 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Diagnostic Devices·0 affected·Feb 26, 2018
High RiskFDA
Gasco Industrial, Corp.
BELCA Soy Sauce, Contenido Neto: Un Gal¿n (128 fl. oz), Distribuido por: Mister Price Inc. San Juan, P.R. 00936
Food·0 affected·Feb 23, 2018
High RiskFDA
King Of Pops
Key Lime Pie Handcrafted All-Natural Pop; Net Wt. 3.2 OZ (90g)
Food·5,739 affected·Feb 23, 2018
High RiskFDA
Gasco Industrial, Corp.
NuChef Soy Sauce, Contenido Neto: Un Gal¿n (128 fl. oz), Packed for Northwestern Selecta
Food·0 affected·Feb 23, 2018
High RiskFDA
Bayer Healthcare Pharmaceuticals, Inc.
Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: B...
Inhaled / Nasal Drugs·528 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
Medical Devices·13 affected·Feb 23, 2018
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound tra...
Surgical Devices·177 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for ...
Surgical Devices·0 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for u...
Surgical Devices·712 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Orthofix, Inc
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Medical Devices·397 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for u...
Surgical Devices·55 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in e...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600
Medical Devices·17 affected·Feb 23, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures t...
Surgical Devices·17 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for ...
Surgical Devices·385 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her c...
Medical Devices·1,575 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged f...
Surgical Devices·315 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged fem...
Medical Devices·35 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Sofradim Production
Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament poly...
Medical Devices·703 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pac...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600
Medical Devices·14 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external p...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Ge Healthcare
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare...
Medical Devices·569 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibr...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automa...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automa...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully autom...
Diabetes Devices·1,026 affected·Feb 22, 2018
High RiskFDA
Munk Pack Inc
Munk Pack PROTEIN COOKIE PEANUT BUTTER CHOCLATE CHIP NET WT 2.96oz (84g); UPC: 853787005351
Dairy·1,774 affected·Feb 21, 2018
High RiskFDA
Munk Pack Inc
Munk Pack PROTEIN COOKIE DOUBLE DARK CHOCOLATE NET WT 2.96oz (84g); UPC: 853787005368
Bakery & Grains·1,774 affected·Feb 21, 2018
High RiskFDA
Renaissance Lakewood, Llc
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufacture...
Injectable Drugs·1,784 affected·Feb 21, 2018
High RiskFDA
Hycor Biomedical Inc
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either ...
Diagnostic Devices·207 affected·Feb 21, 2018
High RiskFDA
Datascope Corporation
Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide co...
Cardiac Devices·655 affected·Feb 21, 2018
High RiskFDA
Allen Medical Systems
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table...
Surgical Devices·83 affected·Feb 21, 2018
High RiskFDA
Datascope Corporation
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide co...
Cardiac Devices·2,714 affected·Feb 21, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to prod...
Medical Devices·291 affected·Feb 21, 2018