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All Product Recalls

49,209 recalls (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 te...
Diagnostic Devices·18,038 affected·Sep 5, 2018
High RiskFDA
Confidence Inc./confidence U.s.a. Inc.
FP0392, For-Men-10, All Natural Formula to Overall Men's Health, A Dietary Supplement, 60 Tablets, UPC: 8 92483 00139 7
Baby Food & Formula·2,016 affected·Sep 4, 2018
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55...
Oral Drugs·8,376 affected·Sep 4, 2018
High RiskFDA
Boehringer Ingelheim Pharmaceuticals, Inc.
Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelhei...
Oral Drugs·998 affected·Sep 4, 2018
High RiskFDA
Coopersurgical, Inc.
Colpo-Pneumo Occluder, Part CPO-6
Medical Devices·32,538 affected·Sep 4, 2018
High RiskFDA
Coopersurgical, Inc.
Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316...
Medical Devices·18,000 affected·Sep 4, 2018
High RiskFDA
Cypress Medical Products Llc
McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin...
Diabetes Devices·400 affected·Sep 4, 2018
High RiskFDA
Ge Healthcare Finland Oy
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE...
Cardiac Devices·59,000 affected·Sep 4, 2018
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
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
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
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
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
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