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High RiskFDA
Steris Corporation
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713
Medical Devices·31 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091
Medical Devices·197 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
Medical Devices·589 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
Medical Devices·170 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product U...
Diagnostic Devices·2,405 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product ...
Diagnostic Devices·1,588 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610
Medical Devices·54 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061
Medical Devices·98 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, steri...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510
Medical Devices·229 affected·Dec 2, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications su...
Medical Devices·716,880 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single us...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitori...
Medical Devices·212,093 affected·Dec 2, 2020
High RiskFDA
Gaza Proveedora De Servicios De Hospedaje Y Alimentacion
Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala...
Topical Drugs·43,875 affected·Dec 1, 2020
High RiskFDA
Gaza Proveedora De Servicios De Hospedaje Y Alimentacion
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC,...
Topical Drugs·26,000 affected·Dec 1, 2020
High RiskFDA
Boston Scientific Corporation
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for ...
Medical Implants·78 affected·Dec 1, 2020
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantati...
Medical Implants·38 affected·Dec 1, 2020
High RiskFDA
Biomet, Inc.
Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
Medical Devices·21 affected·Dec 1, 2020
High RiskFDA
Boston Scientific Corporation
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for ...
Medical Implants·61 affected·Dec 1, 2020
High RiskFDA
Pacific Coast Producers
Tomato Paste in a 6 oz.(170g) metal can Cases size varies - 12, 24 or 28 count. Packaged under brand names of: Happy Harvest, Krog...
Produce·31 affected·Nov 30, 2020
High RiskFDA
Pacific Coast Producers
Italian Style Tomato Paste in a 6 oz. (170g) metal can Cases size varies - 12, 24 or 28 count. Packaged under brand names of: Krog...
Produce·31 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·4 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·4 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·3 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·3 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·6 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Injectable Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·2 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·3 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Medical Devices·5,602 affected·Nov 30, 2020
High RiskFDA
Vallarta Organics Llc
Organic Basil,15 bags, Net. Wt.15Lbs case.
Food·280 affected·Nov 27, 2020
High RiskFDA
Simex Logistics Sa De Cv
CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc. Henderson, NV 890...
Topical Drugs·1,800 affected·Nov 25, 2020
High RiskFDA
Simex Logistics Sa De Cv
+Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic, packaged in bottles of a) 33.8 Oz (1000m...
Topical Drugs·19,340 affected·Nov 25, 2020
High RiskFDA
Simex Logistics Sa De Cv
Lavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC. 1130 Aba St. Blue Ridge...
Topical Drugs·38,016 affected·Nov 25, 2020
High RiskFDA
Simex Logistics Sa De Cv
Health & Hand Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC 1130 Ada St. Blue R...
Topical Drugs·19,008 affected·Nov 25, 2020
High RiskFDA
Simex Logistics Sa De Cv
UVT World Gel Hand Sanitizer 70% Alcohol Content, 33.9 FL OZ (1LT), Distributed By UVT World Newport Beach, CA 92660 www.uvt.world Produc...
Topical Drugs·16,308 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 11000...
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, n...
Surgical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and inten...
Medical Implants·7,428 affected·Nov 25, 2020