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High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-...
Cardiac Devices·16,104 affected·Jul 27, 2020
High RiskFDA
Medical Components, Inc Dba Medcomp
Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Surgical Devices·132 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications...
Cardiac Devices·6,111 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05...
Cardiac Devices·29,653 affected·Jul 27, 2020
High RiskFDA
Indianapolis Fruit Company, Inc.
Garden Cut Organic Coleslaw w/ Carrots, retail unit packaged in 1lb clam-shell, 4 retail units per wholesale case, retail unit UPC: 05349...
Food·126 affected·Jul 24, 2020
High RiskFDA
Vilvet Pharmaceuticals Inc.
VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine su...
Oral Drugs·1,716 affected·Jul 24, 2020
High RiskFDA
Vilvet Pharmaceuticals Inc.
VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyami...
Oral Drugs·11,640 affected·Jul 24, 2020
High RiskFDA
Nuvasive Specialized Orthopedics Inc
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Pr...
Medical Devices·41 affected·Jul 24, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of ...
Cardiac Devices·1,239 affected·Jul 24, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic...
Cardiac Devices·110 affected·Jul 24, 2020
High RiskFDA
Intrinsic Therapeutics, Inc.
Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for reducing the incidence of reherniat...
Medical Devices·110 affected·Jul 24, 2020
High RiskFDA
Ra Medical Systems, Inc.
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vas...
Medical Devices·54 affected·Jul 24, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Pain Au Levain Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight...
Bakery & Grains·62 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Poppy Seed Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantit...
Bakery & Grains·14 affected·Jul 23, 2020
High RiskFDA
Stick E Fingers Bbq Llc
Stick-E Fingers Barbecue All Purpose Rub is a dry rub, packaged in 13.2 oz plastic jar, UPC 8 60003 24004 5. No company's address listed...
Dairy·181 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Everything Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantit...
Bakery & Grains·48 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Pesto Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities s...
Dairy·55 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Plain Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities s...
Bakery & Grains·48 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Italian Farm Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 2...
Bakery & Grains·34 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Sesame Seed Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quanti...
Bakery & Grains·24 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Garlic Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities ...
Bakery & Grains·20 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Desem Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 22 oz. U...
Bakery & Grains·14 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Onion Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities s...
Bakery & Grains·24 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Olive Levain Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 1...
Bakery & Grains·16 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Rosemary Garlic French Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, ne...
Bakery & Grains·36 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Sourdough Rye Bread, San Francisco Street Bakery brand, keep at ambient temperature. Sold as an individual unit through on-site retail s...
Bakery & Grains·2 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
Salt Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities sp...
Bakery & Grains·16 affected·Jul 23, 2020
High RiskFDA
San Francisco Street Bakery Inc.
French Bread, San Francisco Street Bakery brand, keep at ambient temperature. French Bread sold as an individual unit through the firm's...
Bakery & Grains·10 affected·Jul 23, 2020
High RiskFDA
Real Clean Distribuciones Sa De Cv
scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol 70%), 16.9 FL OZ/500 mL bottle, Distributed by Scent Theo...
Drugs·917,280 affected·Jul 23, 2020
High RiskFDA
Real Clean Distribuciones Sa De Cv
LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC Nashville, TN 3721...
Topical Drugs·90,288 affected·Jul 23, 2020
High RiskFDA
Real Clean Distribuciones Sa De Cv
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b)...
Drugs·975,720 affected·Jul 23, 2020
High RiskFDA
Real Clean Distribuciones Sa De Cv
scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, Distributed by Scent Theory Products, LLC New York, NY 100...
Drugs·504,000 affected·Jul 23, 2020
High RiskFDA
Remel Europe Ltd.
Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Borde...
Diagnostic Devices·79 affected·Jul 23, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Smith & Nephew Orthopaedics Ag
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size ...
Medical Devices·528 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Philips Medical Systems Gmbh, Dmc
CombiDiagnost R90 Software Version R1.0 and R1.1
Diagnostic Devices·322 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
Medical Devices·0 affected·Jul 22, 2020