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High RiskFDA
Beaumont Bio-med, Inc.
Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., W...
Oral Drugs·314 affected·Aug 31, 2018
High RiskFDA
Beaumont Bio-med, Inc.
Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., ...
Oral Drugs·140 affected·Aug 31, 2018
High RiskFDA
Beaumont Bio-med, Inc.
Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, I...
Oral Drugs·109 affected·Aug 31, 2018
High RiskFDA
Beaumont Bio-med, Inc.
Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio...
Oral Drugs·420 affected·Aug 31, 2018
High RiskFDA
Widex A/s
Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not ...
Medical Devices·2 affected·Aug 31, 2018
High RiskFDA
Ge Healthcare, Llc
Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Medical Devices·182,640 affected·Aug 31, 2018
High RiskFDA
Ge Healthcare, Llc
Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Medical Devices·3,864 affected·Aug 31, 2018
High RiskFDA
Accuray Incorporated
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Medical Devices·259 affected·Aug 31, 2018
High RiskFDA
Ge Healthcare, Llc
Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Medical Devices·73,673 affected·Aug 31, 2018
High RiskFDA
Ge Healthcare, Llc
Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Medical Devices·182,640 affected·Aug 31, 2018
High RiskFDA
Alkano Chemicals, Inc
Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendl...
Drugs·8 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging ...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
Medical Devices·1 affected·Aug 30, 2018
High RiskFDA
Medline Industries Inc
Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a f...
Medical Devices·113,302 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imagi...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Urine Collection Cups, Cat. No. 364941
Medical Devices·29,982,150 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Becton Dickinson & Company
KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
Medical Devices·29,982,150 affected·Aug 30, 2018
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Medical Devices·5 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The ...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Arrow International Inc
Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) cent...
Medical Devices·105 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imagi...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Becton Dickinson & Company
KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
Medical Devices·29,982,150 affected·Aug 30, 2018
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
Mitek Screw and Washer Depth Gauge, Product Code 219024
Medical Devices·401 affected·Aug 30, 2018
High RiskFDA
Cedarlane Natural Foods Inc/frankly Fresh Foods Inc.
CedarLane Organic Salads; Couscous, Veggies & Chickpeas with Citrus Dressing. NET WT 9 oz. -Gluten Free -Vegetarian Perishable, ...
Produce·579 affected·Aug 29, 2018
High RiskFDA
Campomex Usa Corp
Campomex USA fresh cilantro: 5 dozens (60) per box.
Food·56 affected·Aug 29, 2018
High RiskFDA
Sanrai International Llc
Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor syst...
Respiratory Devices·150 affected·Aug 29, 2018
CriticalFDA
Data Innovations, Llc
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer...
Medical Devices·9 affected·Aug 29, 2018
High RiskFDA
Humco Holding Group, Inc
Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 039...
Drugs·0 affected·Aug 28, 2018
RecallFDA
Pfizer Inc.
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, I...
Injectable Drugs·1,580 affected·Aug 28, 2018
High RiskFDA
Humco Holding Group, Inc
Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 gram...
Drugs·10 affected·Aug 28, 2018
High RiskFDA
Humco Holding Group, Inc
Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 03...
Drugs·0 affected·Aug 28, 2018
High RiskFDA
Stryker Gmbh
Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pedi...
Medical Devices·867 affected·Aug 28, 2018
High RiskFDA
Hitachi Healthcare Americas Corp Informatics Division
VidiStar(TM) PACS & DICOM Viewer Software system
Medical Devices·12 affected·Aug 28, 2018
CriticalFDA
Alcon Research, Ltd.
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
Medical Implants·30,561 affected·Aug 28, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantit...
Diagnostic Devices·6,630 affected·Aug 28, 2018
High RiskFDA
Stryker Gmbh
Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pedi...
Medical Devices·832 affected·Aug 28, 2018
CriticalFDA
Alcon Research, Ltd.
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
Medical Implants·14,264 affected·Aug 28, 2018
High RiskFDA
Abbott Laboratories, Inc
Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used fo...
Medical Devices·99 affected·Aug 28, 2018
High RiskFDA
Stryker Gmbh
Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pedi...
Medical Devices·1,355 affected·Aug 28, 2018
RecallFDA
Mylan Pharmaceuticals Inc.
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Ma...
Oral Drugs·5,790 affected·Aug 27, 2018
CriticalFDA
Sca Pharmaceuticals, Inc.
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Kn...
Injectable Drugs·1,384 affected·Aug 27, 2018
CriticalFDA
Quva Pharma, Inc.
Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 088...
Drugs·528 affected·Aug 27, 2018
RecallFDA
Jubilant Cadista Pharmaceuticals, Inc.
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
Oral Drugs·89,722 affected·Aug 27, 2018
High RiskFDA
Califia Farms Llc
Califia Farms 100% Arabica Coffee; Mocha Cold Brew Coffee with Almond Milk 48 fl. oz. plastic bottle. Dairy Free UPC: 85290900350...
Dairy·24,507 affected·Aug 24, 2018
RecallFDA
Stewart's Shops Corp.
Stewart's Ice Cream Caramel Cone Crunch Carton, 1 pint, keep frozen, UPC: 082086444718
Dairy·5,455 affected·Aug 24, 2018
High RiskFDA
Lgm Pharma Llc
Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1
Drugs·1,307 affected·Aug 24, 2018