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High RiskFDA
Brainlab Ag
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Medical Devices·18 affected·Jul 16, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals ...
Diagnostic Devices·1 affected·Jul 16, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3...
Cardiac Devices·95,212 affected·Jul 16, 2020
CriticalFDA
Winter Gardens Quality Foods, Inc.
Whole Foods Spinach Artichoke Dip ,4-12 oz containers, Lot # 248 Manufactured on 7/8/2020 Use By: 07/26/2020
Produce·71 affected·Jul 15, 2020
High RiskFDA
Happy Colon Foods
Happy Colon MMMM Chocolate Chip Cookie 0.98oz UPC 56817 00703
Bakery & Grains·1,538 affected·Jul 15, 2020
High RiskFDA
Happy Colon Foods
Happy Colon Yum Shortbread Cookie 0.98oz UPC 56817 00704
Bakery & Grains·1,538 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provid...
Medical Devices·6 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide...
Medical Devices·1,550 affected·Jul 15, 2020
High RiskFDA
Hager & Meisinger Gmbh
SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard struc...
Medical Devices·144 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral n...
Medical Devices·13 affected·Jul 15, 2020
High RiskFDA
Sicat Gmbh & Co. Kg
SICAT IMPLANT V2.0
Medical Implants·853 affected·Jul 15, 2020
High RiskFDA
Qiagen Sciences Llc
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and dif...
Respiratory Devices·1,474 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neur...
Medical Devices·2,444 affected·Jul 15, 2020
High RiskFDA
Neurologica Corporation
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is inte...
Medical Devices·35 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neura...
Medical Devices·1,424 affected·Jul 15, 2020
High RiskFDA
Medtronic Inc.
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Medical Devices·3,588 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide...
Medical Devices·2,197 affected·Jul 15, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA,...
Topical Drugs·28,596 affected·Jul 14, 2020
High RiskFDA
Soluciones Cosmeticas, Sa De Cv
Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 110...
Topical Drugs·2,486,400 affected·Jul 14, 2020
High RiskFDA
Inpeco S.a.
Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Autom...
Medical Devices·136 affected·Jul 14, 2020
High RiskFDA
Olympus Corporation Of The Americas
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Medical Devices·21 affected·Jul 14, 2020
High RiskFDA
Inpeco S.a.
Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a ...
Medical Devices·104 affected·Jul 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin...
Medical Devices·282 affected·Jul 14, 2020
High RiskFDA
Thomas Scientific
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Medical Devices·115,800 affected·Jul 14, 2020
High RiskFDA
Flagstone Foods Llc
Wegmans PECAN BLEND Supreme Pecans, Cashews & Pistachios NET WT 16 OZ(1 LB) 454g plastic bag Ingredients: Pecans, Cashews, Dry Roasted Pi...
Food·280 affected·Jul 13, 2020
RecallFDA
Lopez Gonzalez Santana Corporation
BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples)
Supplements·32,179 affected·Jul 13, 2020
High RiskFDA
Siam Trading Inc.
Khaotan Rice Cracker, Net Wt. 150g
Bakery & Grains·50 affected·Jul 13, 2020
High RiskFDA
Bausch Health Companies, Inc.
Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuti...
Topical Drugs·35,424 affected·Jul 13, 2020
RecallFDA
Fresenius Kabi Usa, Llc
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10
Injectable Drugs·63,067 affected·Jul 13, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Ch...
Diagnostic Devices·4,076 affected·Jul 13, 2020
RecallFDA
Orasure Technologies, Inc.
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for ...
Diagnostic Devices·13 affected·Jul 13, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration i...
Diagnostic Devices·149,370 affected·Jul 13, 2020
High RiskFDA
4e Brands North America, Llc
Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier Inte...
Supplements·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10...
Supplements·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 ...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) ...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b...
Drugs·17,359,247 affected·Jul 11, 2020
CriticalFDA
4e Brands North America, Llc
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 ...
Drugs·17,359,247 affected·Jul 11, 2020
CriticalFDA
4e Brands North America, Llc
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bott...
Drugs·0 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl...
Drugs·17,359,247 affected·Jul 11, 2020
CriticalFDA
4e Brands North America, Llc
blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
Keryx Biopharmaceuticals, Inc.
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, ...
Oral Drugs·59,820 affected·Jul 10, 2020
High RiskFDA
Randox Laboratories, Ltd.
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Diagnostic Devices·1,497 affected·Jul 10, 2020
High RiskFDA
Maquiladora Miniara Sa De Cv
Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carre...
Topical Drugs·245,500 affected·Jul 9, 2020
High RiskFDA
Mako Surgical Corporation
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Medical Devices·12 affected·Jul 9, 2020
High RiskFDA
Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures ...
Medical Devices·25 affected·Jul 8, 2020
High RiskFDA
New Wave Endo-surgical, Corp.
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Medical Devices·295 affected·Jul 8, 2020