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High RiskFDA
Philips Medical Systems (cleveland) Inc
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imagin...
Cardiac Devices·61 affected·Sep 4, 2018
CriticalFDA
Alpha Omega Engineering
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelec...
Surgical Devices·29 affected·Sep 4, 2018
High RiskFDA
Leica Microsystems, Inc.
Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for ...
Diagnostic Devices·1 affected·Sep 4, 2018
High RiskFDA
Ge Healthcare Finland Oy
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CAR...
Cardiac Devices·47,937 affected·Sep 4, 2018
RecallUSDA
Bahar, Llc
Bahar LLC Recalls Frozen, Raw Beef Dumpling Products Produced without Benefit of Inspection
Beef·0 affected·Sep 4, 2018
RecallUSDA
Bahar, Llc
Bahar LLC Retira Productos De Albndigas De Carne Cruda Congelada Producidos Sin El Beneficio De La Inspeccin
Beef·0 affected·Sep 4, 2018
High RiskFDA
Biolyte Laboratories, Llc
NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bott...
Topical Drugs·500 affected·Aug 31, 2018
High RiskFDA
Beaumont Bio-med, Inc.
Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-M...
Oral Drugs·192 affected·Aug 31, 2018
High RiskFDA
Beaumont Bio-med, Inc.
Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Wauk...
Oral Drugs·160 affected·Aug 31, 2018
High RiskFDA
Beaumont Bio-med, Inc.
Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, I...
Oral Drugs·124 affected·Aug 31, 2018
High RiskFDA
Beaumont Bio-med, Inc.
Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon,...
Oral Drugs·90 affected·Aug 31, 2018
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
CriticalUSDA
J T M Provisions Company
J.T.M. Provisions Company Recalls Cooked Ground Beef Products Due To Possible Listeria Contamination
Beef·0 affected·Aug 31, 2018
RecallUSDA
J T M Provisions Company
J.T.M. Provisions Company Retira Productos De Carne Molida Cocidos Debido A Una Posible Contaminacin Con Listeria
Beef·0 affected·Aug 31, 2018
RecallCPSC
Core Health & Fitness Distributors Nationwide From October 2017 Through June 2018 For Between $7,500 And $9,950.
Core Health & Fitness Recalls Stairmaster Stepmill Exercise Equipment Due to Fall Hazard (Recall Alert)
Sports & Recreation·3,500 affected·Aug 30, 2018
CriticalCPSC
Petsmart Stores Nationwide From March 2017 Through July 2018 For About $35 (20 Inch) And $40 (30 Inch).
PetSmart Recalls Strip Lights for Reptile Cages Due to Fire Hazard
Consumer Products·23,000 affected·Aug 30, 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
RecallUSDA
Publix Supermarkets, Inc., Deli Plant
Publix Super Markets Inc. Recalls Ground Chuck Products Due To Possible E. coli O26 Contamination
Beef·0 affected·Aug 30, 2018
RecallUSDA
Publix Supermarkets, Inc., Deli Plant
Publix Super Markets Inc. Retira Productos De Aguja/Mandril Molida Debido A Una Posible Contaminacin De E.coli O26
Meat & Poultry·0 affected·Aug 30, 2018
RecallCPSC
Bsn Sports And Us Games Catalogs, And Online At Www.amazon.com, Www.athleticconnection.com, Www.bsnsports.com, Www.esportsonline.com And Www.usgames.com From February 2017 Through June 2018 For About $10 For An Individual Rubber Critter And Up To $145 For A Set.
BSN SPORTS Recalls Rubber Critter Toys Due to Violation of Federal Lead Paint Ban (Recall Alert)
Toys·31,200 affected·Aug 29, 2018
RecallCPSC
Through Cybex Direct Sales Representatives And Fitness Equipment Dealers To Fitness Facilities And Gymnasiums And Online At Www.cybexintl.com From 1989 Through 2009 For Between $1,000 And $3,400.
Cybex Recalls Weight-Lifting Equipment Due to Serious Injury Hazards
Consumer Products·15,000 affected·Aug 29, 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