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High RiskFDA
Coca Cola
Dr Pepper Cherry 20 oz UPC 078000098402
Food·3 affected·Jun 18, 2020
High RiskFDA
Anjon Holdings
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fi...
Medical Devices·249 affected·Jun 18, 2020
High RiskFDA
Philips North America, Llc
Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitor...
Medical Devices·9,705 affected·Jun 18, 2020
High RiskFDA
Philips North America, Llc
Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI ...
Medical Devices·24,545 affected·Jun 18, 2020
High RiskFDA
Chembio Diagnostics, Inc
Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection a...
Medical Devices·126 affected·Jun 18, 2020
High RiskFDA
Philips North America, Llc
Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Mon...
Medical Devices·118 affected·Jun 18, 2020
High RiskFDA
Chembio Diagnostics, Inc
Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobuli...
Medical Devices·7,674 affected·Jun 18, 2020
High RiskFDA
Flagstone Foods Llc
NORTH STAR TRADING COMPANY SWEET & SALTY CARAMEL TRAIL MIX NET WT 14OZ (396g) MANUFACTURED FOR YOUR MILITARY EXCHANGES BY FLAGSTONE FOODS...
Food·594 affected·Jun 17, 2020
High RiskFDA
Brill Inc
Brill 30 lb. cases of 480 1.0 oz. chocolate chip with mini colored candy pieces frozen cookie dough, MDM # 10194626, Manufactured by Bril...
Bakery & Grains·7,560 affected·Jun 17, 2020
High RiskFDA
Preferred Pharmaceuticals, Inc.
Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, ...
Oral Drugs·144 affected·Jun 17, 2020
High RiskFDA
Beckman Coulter Biomedical Gmbh
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling sys...
Diagnostic Devices·32 affected·Jun 17, 2020
High RiskFDA
Wellspect Healthcare (division Of Dentsply Ih Ab)
LoFric Origo, Tiemann, 16in, FR12 urinary catheters
Surgical Devices·0 affected·Jun 17, 2020
High RiskFDA
Fhc, Inc.
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well...
Medical Devices·6 affected·Jun 17, 2020
High RiskFDA
Wellspect Healthcare (division Of Dentsply Ih Ab)
LoFric Origo, Tiemann, 16in, FR14 urinary catheters
Surgical Devices·0 affected·Jun 17, 2020
High RiskFDA
Wellspect Healthcare (division Of Dentsply Ih Ab)
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Surgical Devices·0 affected·Jun 17, 2020
High RiskFDA
Resource Optimization & Innovation Llc
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed ...
Medical Devices·66 affected·Jun 17, 2020
High RiskFDA
Sca Pharmaceuticals
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 060...
Drugs·333 affected·Jun 16, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Can...
Drugs·78,132 affected·Jun 16, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottl...
Drugs·132,336 affected·Jun 16, 2020
High RiskFDA
Synthes Produktions Gmbh
MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures ...
Medical Devices·41 affected·Jun 16, 2020
High RiskFDA
Luminex Corporation
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a ...
Diagnostic Devices·3,016 affected·Jun 15, 2020
High RiskFDA
Luminex Corporation
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a ...
Diagnostic Devices·3,016 affected·Jun 15, 2020
High RiskFDA
Yusef Manufacturing Laboratories, Llc
Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5...
Drugs·0 affected·Jun 13, 2020
High RiskFDA
Beaming White Llc
Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95t...
Drugs·0 affected·Jun 12, 2020
High RiskFDA
The Harvard Drug Group
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex,...
Oral Drugs·1,906 affected·Jun 12, 2020
High RiskFDA
Aurobindo Pharma Usa Inc.
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road ...
Oral Drugs·1,440 affected·Jun 12, 2020
High RiskFDA
Beaming White Llc
Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vanco...
Drugs·0 affected·Jun 12, 2020
High RiskFDA
Beaming White Llc
Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205 NE 95th St., Van...
Drugs·0 affected·Jun 12, 2020
High RiskFDA
Medtronic Xomed, Inc.
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing...
Surgical Devices·673 affected·Jun 12, 2020
High RiskFDA
Golden Nutrition Inc
Anti-Viral Immune Enhance "Corona Virus (COVID-19) " "Influenza (H1N1)" "Bronchitis" "Common Cold" 60 Capsules, Dietary Supplement, Manuf...
Supplements·15,698 affected·Jun 11, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Bal...
Oral Drugs·6,540 affected·Jun 11, 2020
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, ...
Injectable Drugs·82,426 affected·Jun 11, 2020
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, ...
Injectable Drugs·17,998 affected·Jun 11, 2020
High RiskFDA
Crown Laboratories
Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, T...
Topical Drugs·62,274 affected·Jun 10, 2020
High RiskFDA
Alembic Pharmaceuticals Limited
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) ...
Oral Drugs·19,153 affected·Jun 10, 2020
High RiskFDA
Crown Laboratories
Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN...
Topical Drugs·35,931 affected·Jun 10, 2020
High RiskFDA
Ethicon, Inc.
PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W181...
Medical Devices·99,612 affected·Jun 10, 2020
High RiskFDA
Intuitive Surgical, Inc.
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Surgical Devices·67 affected·Jun 10, 2020
High RiskFDA
Nuvasive Inc
Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative ...
Medical Devices·23 affected·Jun 10, 2020
High RiskFDA
Elekta Instrument Ab
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Medical Devices·51 affected·Jun 10, 2020
High RiskFDA
New Standard Device Inc
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Medical Devices·426 affected·Jun 8, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (ster...
Medical Devices·352 affected·Jun 8, 2020
High RiskFDA
Hocoma Ag
Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 Lo...
Medical Devices·494 affected·Jun 8, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (steri...
Medical Devices·5 affected·Jun 8, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (ste...
Medical Devices·25 affected·Jun 8, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (ster...
Medical Devices·2,415 affected·Jun 8, 2020
High RiskFDA
Stumptown Coffee Corp
Stumptown Cold Brew Coffee and Chocolate with Oatmilk. Product is TetraPak Prisma Pak aseptic packaging. Keep refrigerated. Net 11 fl. ...
Dairy·900 affected·Jun 5, 2020
High RiskFDA
Marksans Pharma Limited
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap ...
Oral Drugs·11,279 affected·Jun 5, 2020