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High RiskFDA
Boston Scientific Corporation
PROPONENT Pacemaker
Cardiac Devices·0 affected·Sep 10, 2018
High RiskFDA
Ge Healthcare Biosciences
DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for...
Medical Devices·39 affected·Sep 10, 2018
High RiskFDA
Boston Scientific Corporation
ACCOLADE Pacemaker
Cardiac Devices·0 affected·Sep 10, 2018
High RiskFDA
Vivorte, Inc.
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Medical Devices·12 affected·Sep 9, 2018
CriticalFDA
Market Of Choice Inc
Sesame Noodle Salad Vegan, packaged in 8 oz. or 16 oz. plastic container. UPC of 8 oz. container: 0 211630 203994. UPC of 16 oz. co...
Beverages·559 affected·Sep 7, 2018
CriticalFDA
Gravel Ridge Farms
Shelled eggs in blank cardboard cases at 2.5 dozen a case. Shelled eggs in dozen cartons labeled as "Gravel Ridge Farms Cullman County...
Food·55,000 affected·Sep 7, 2018
High RiskFDA
Noven Pharmaceuticals, Inc.
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Mia...
Topical Drugs·26,217 affected·Sep 7, 2018
High RiskFDA
Noven Pharmaceuticals, Inc.
Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmace...
Topical Drugs·213,714 affected·Sep 7, 2018
High RiskFDA
Noven Pharmaceuticals, Inc.
Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Mia...
Topical Drugs·74,908 affected·Sep 7, 2018
High RiskFDA
Noven Pharmaceuticals, Inc.
Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuti...
Topical Drugs·149,631 affected·Sep 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro ...
Diagnostic Devices·3,956 affected·Sep 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic t...
Diagnostic Devices·18,396 affected·Sep 7, 2018
High RiskFDA
Abbott Laboratories, Inc
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Medical Devices·159 affected·Sep 7, 2018
High RiskFDA
Bayer Medical Care, Inc.
Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product ...
Medical Devices·1,142,836 affected·Sep 7, 2018
High RiskFDA
Vital Scientific N.v.
V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer,...
Diagnostic Devices·192 affected·Sep 7, 2018
RecallFDA
Invagen Pharmaceuticals, Inc.
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560...
Oral Drugs·26,496 affected·Sep 6, 2018
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
Injectable Drugs·5,184 affected·Sep 6, 2018
RecallFDA
Par Pharmaceutical, Inc.
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical...
Oral Drugs·16,207 affected·Sep 6, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09P...
Medical Implants·107 affected·Sep 6, 2018
CriticalFDA
Stihler Electronic Gmbh
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer...
Medical Devices·1 affected·Sep 6, 2018
CriticalFDA
Stihler Electronic Gmbh
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer i...
Medical Devices·821 affected·Sep 6, 2018
High RiskFDA
Cryolife, Inc.
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Medical Devices·1 affected·Sep 6, 2018
CriticalFDA
Elaboraciones Felo, Inc.
Super Pizza Turnover, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603
Food·29,133 affected·Sep 5, 2018
High RiskFDA
Wismettac Asian Foods (usa) Dba Nishimoto Trading Co Ltd
EVERYBURGER - Burger-Shaped Chocolate Cookies: NET WT. 2.32 oz. (66 g) There are 2 packing sizes; 10 items per case and 80 items per ca...
Bakery & Grains·40,197 affected·Sep 5, 2018
CriticalFDA
Elaboraciones Felo, Inc.
Pizza Turnover, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603
Food·7,011 affected·Sep 5, 2018
CriticalFDA
Elaboraciones Felo, Inc.
Square Shell for Turnovers, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603
Food·76 affected·Sep 5, 2018
High RiskFDA
Cordis Corporation
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, ...
Medical Implants·162 affected·Sep 5, 2018
High RiskFDA
Thoratec Switzerland Gmbh
Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
Medical Devices·1,569 affected·Sep 5, 2018
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
RecallFDA
Confidence Inc./confidence U.s.a. Inc.
FP0191, Confidence, Bone-Lock WITHGENISTEIN AND CHLOROPHYLL, A Dietary Supplement, 60 tablets per bottle, UPC: 8 92483 00145 8
Supplements·538 affected·Sep 4, 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
CriticalFDA
H & C Food Inc.
Fish Balls, packaged in a red and white plastic bag with gold font, NET WT: 14OZ (400g), UPC: 6 953006 4 50093. Keep Frozen.
Seafood·0 affected·Sep 4, 2018
CriticalFDA
H & C Food Inc.
Fuzhou Fish Balls, packaged in a blue and white package bag, in two sizes: Net WT: 14 OZ (400g), UPC: 6 953640 05000 and Net WT:4.5 lbs...
Seafood·0 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
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
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