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High RiskFDA
Pfizer Inc.
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest,...
Injectable Drugs·280,340 affected·Jul 9, 2019
CriticalFDA
Jubilant Cadista Pharmaceuticals, Inc.
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contai...
Oral Drugs·11,412 affected·Jul 9, 2019
High RiskFDA
Pfizer Inc.
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, ...
Injectable Drugs·58,200 affected·Jul 9, 2019
CriticalFDA
Edwards Lifesciences, Llc
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
Cardiac Devices·1,754 affected·Jul 9, 2019
High RiskFDA
Voco Gmbh
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities...
Medical Implants·5 affected·Jul 9, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643
Diagnostic Devices·2 affected·Jul 9, 2019
CriticalFDA
Edwards Lifesciences, Llc
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
Cardiac Devices·2,208 affected·Jul 9, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
Diagnostic Devices·17 affected·Jul 9, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
Diagnostic Devices·44 affected·Jul 9, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
Diagnostic Devices·143 affected·Jul 9, 2019
High RiskFDA
Piramal Critical Care, Inc.
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Pri...
Injectable Drugs·2,155 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5600 Integrated System, clinical chemistry analyzer
Medical Devices·2,531 affected·Jul 8, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used wi...
Diagnostic Devices·95 affected·Jul 8, 2019
High RiskFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm...
Surgical Devices·4,654 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 250 Chemistry System, clinical chemistry analyzer
Medical Devices·2 affected·Jul 8, 2019
High RiskFDA
Smiths Medical Asd Inc.
GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL...
Medical Devices·3,952,425 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 250 Chemistry System, clinical chemistry analyzer
Medical Devices·30 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Medical Devices·55 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Medical Devices·0 affected·Jul 8, 2019
CriticalFDA
Coopersurgical, Inc.
TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is ...
Medical Devices·49,813 affected·Jul 8, 2019
High RiskFDA
Smiths Medical Asd Inc.
GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, ...
Medical Devices·3,952,509 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Medical Devices·1,051 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 250AT Chemistry System, clinical chemistry analyzer
Medical Devices·30 affected·Jul 8, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric ...
Diagnostic Devices·467 affected·Jul 8, 2019
High RiskFDA
Gh Foods
Kroger Stuffed Mushrooms; Net Wt. 7 oz. (193 g) over-wrapped tray Perishable, Keep Refrigerated. Cook before consumption UPC: 26766...
Food·985 affected·Jul 4, 2019
CriticalFDA
Topway Enterprises, Inc
Salmon (Cut)
Seafood·8,300 affected·Jul 3, 2019
CriticalFDA
Topway Enterprises, Inc
Yellowfin Tuna
Seafood·3,100 affected·Jul 3, 2019
High RiskFDA
Valeritas, Incorporated
DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03
Medical Devices·49,074 affected·Jul 3, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional...
Medical Devices·0 affected·Jul 3, 2019
High RiskFDA
Xcision Medical Systems, Llc
GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for...
Medical Devices·2 affected·Jul 3, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images...
Medical Devices·0 affected·Jul 3, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images...
Medical Devices·0 affected·Jul 3, 2019
High RiskFDA
Valeritas, Incorporated
DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
Medical Devices·60 affected·Jul 3, 2019
High RiskFDA
Capso Vision, Inc.
CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The Caps...
Medical Devices·44 affected·Jul 3, 2019
High RiskFDA
Valeritas, Incorporated
DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
Medical Devices·21,714 affected·Jul 3, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional im...
Medical Devices·0 affected·Jul 3, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectio...
Medical Devices·0 affected·Jul 3, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-secti...
Medical Devices·0 affected·Jul 3, 2019
High RiskFDA
Pedialift Llc
PediaLift Access Device, Device Identifier: B751PDLFT0
Medical Devices·11 affected·Jul 3, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy Inc., One CVS D...
Ophthalmic Drugs·0 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881, Product Size: 2 x 10 mL, Distributed by: CVS Pharmac...
Ophthalmic Drugs·39,744 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Equate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 15 mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR ...
Drugs·259,104 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, ...
Ophthalmic Drugs·222,096 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy, Inc., One CVS Dr...
Ophthalmic Drugs·100,680 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (1...
Ophthalmic Drugs·238,968 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item #881532, Distributed by: CVS Pharmacy Inc., One CV...
Topical Drugs·284,232 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
TRP Pink Eye Relief, 10 mL, NDC 17312-013-15
Drugs·1,381,638 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35
Topical Drugs·651,528 affected·Jul 2, 2019