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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
CriticalCPSC
Online At Amazon.com And Ebay.com From August 2017 Through March 2019 For Between $6 And $13.
Just Love Fashion Recalls Children's Pajama Pants Due to Violation of Federal Flammability Standard (Recall Alert)
Children's Products·1,400 affected·Jul 3, 2019
RecallCPSC
Urm Stores And Independent Pharmacies Nationwide And Online At Target.com From July 2015 Through June 2018 For About $7.
Nature's Truth Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Closure Requirements
Children's Products·22,100 affected·Jul 3, 2019
CriticalCPSC
Online At Www.thecompanystore.com From September 2018 Through April 2019 For About $50.
The Company Store Recalls Girl's Pajama Sets Due to Violation of Federal Flammability Standard (Recall Alert)
Kitchenware·2,500 affected·Jul 3, 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
RecallCPSC
Specialty Bicycle Retailers Nationwide Or Directly To Consumers By Faraday From March 2015 Through March 2019 For Between $2,500 And $3,500.
Electric Bicycles Recalled by Faraday; Seat Post Poses Fall Hazard
Bicycles & Wheeled Sports·4,450 affected·Jul 2, 2019
RecallCPSC
Bicycles With The Recalled Forks Were Sold At Bicycle Stores Nationwide From January 2019 Through March 2019. Bicycle Forks Sold As Aftermarket Accessories Were Sold At Bicycle Stores From February 2019 Through April 2019 For Between $700 And $1,000.
SRAM Recalls RockShox Front Suspension Forks Due to Crash and Injury Hazards
Consumer Products·840 affected·Jul 2, 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
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woo...
Ophthalmic Drugs·48,168 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
TRP Blur Relief, 15 mL, NDC 17312-002-11
Drugs·24,144 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Phar...
Drugs·90,072 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Alta...
Ophthalmic Drugs·81,403 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, 30 Sterile Single...
Ophthalmic Drugs·114,504 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry Eye Therapy, 0.25 FL OZ (7.5 mL), Mfd....
Topical Drugs·24 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), Distributed by: Walmart Stores, Inc., Bentonville, AR 7...
Ophthalmic Drugs·17,613 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05
Drugs·49,527 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CVS Pharmacy, Inc., One CVS D...
Ophthalmic Drugs·531,936 affected·Jul 2, 2019