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High RiskFDA
Whole Foods Market Brand 365, Llc
MULTI GRAIN CROISSANT 6 PK
Food·8 affected·Nov 2, 2016
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 T...
Injectable Drugs·5 affected·Nov 2, 2016
High RiskFDA
Fallon Wellness Pharmacy, L.l.c.
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057...
Injectable Drugs·10 affected·Nov 2, 2016
High RiskFDA
Ascend Laboratories Llc
Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, D...
Oral Drugs·1,739 affected·Nov 2, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to ...
Medical Devices·7 affected·Nov 2, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to p...
Medical Devices·7 affected·Nov 2, 2016
High RiskFDA
Hospira Inc.
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-40...
Injectable Drugs·797,800 affected·Nov 1, 2016
High RiskFDA
Synthes (usa) Products Llc
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Medical Devices·84 affected·Nov 1, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for singl...
Cardiac Devices·4,657 affected·Nov 1, 2016
High RiskFDA
Carefusion 303, Inc.
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion p...
Medical Devices·613,800 affected·Nov 1, 2016
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy
Medical Devices·6 affected·Oct 31, 2016
High RiskFDA
Sorin Group Usa, Inc.
Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, ...
Medical Implants·845 affected·Oct 31, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S...
Diabetes Devices·97 affected·Oct 31, 2016
High RiskFDA
Spectranetics Corporation
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative oc...
Medical Devices·873 affected·Oct 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in ...
Surgical Devices·198 affected·Oct 31, 2016
High RiskFDA
Spectranetics Corporation
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 Th...
Surgical Devices·14,624 affected·Oct 31, 2016
High RiskFDA
Owens & Minor Distribution, Inc.
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 1...
Medical Devices·568 affected·Oct 31, 2016
High RiskFDA
Aldi Inc
Simply Nature Organic Red Split Lentils, 16 oz bag, UPC 041498299507
Food·73,920 affected·Oct 28, 2016
High RiskFDA
Aldi Inc
Simply Nature Organic Green Lentils, 16 oz bag, UPC 041498299514
Food·73,920 affected·Oct 28, 2016
High RiskFDA
Nationwide Laboratories, Llc
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, Ne...
Oral Drugs·5,786,653 affected·Oct 28, 2016
High RiskFDA
Nationwide Laboratories, Llc
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, Ne...
Oral Drugs·6,333,669 affected·Oct 28, 2016
High RiskFDA
Nationwide Laboratories, Llc
Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000...
Oral Drugs·2,882,661 affected·Oct 28, 2016
High RiskFDA
Nationwide Laboratories, Llc
Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000...
Oral Drugs·2,514,500 affected·Oct 28, 2016
High RiskFDA
Natus Medical Incorporated
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 00622...
Medical Devices·2,619 affected·Oct 28, 2016
High RiskFDA
Integra York Pa, Inc
Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surg...
Surgical Devices·150 affected·Oct 28, 2016
High RiskFDA
Integra York Pa, Inc
Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended...
Surgical Devices·50 affected·Oct 28, 2016
High RiskFDA
Teleflex Medical
Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS ...
Medical Devices·2,674,650 affected·Oct 27, 2016
High RiskFDA
Teleflex Medical
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the o...
Medical Devices·2,674,650 affected·Oct 27, 2016
High RiskFDA
Teleflex Medical
LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral,...
Medical Devices·2,674,650 affected·Oct 27, 2016
High RiskFDA
Teleflex Medical
LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topica...
Medical Devices·2,674,650 affected·Oct 27, 2016
High RiskFDA
Brainlab Ag
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Medical Devices·29 affected·Oct 27, 2016
High RiskFDA
Pastian's Bakery
French Baguette Bread. 9.5 oz. Clear Plastic Bag. 1 loaf
Bakery & Grains·2 affected·Oct 26, 2016
High RiskFDA
Pastian's Bakery
Homestyle Texas Toast. 1 lb. 8 oz. Clear Plastic Bag. 1 loaf
Food·121 affected·Oct 26, 2016
High RiskFDA
Pastian's Bakery
Texas Toast. 1 lb. 8 oz. Clear Plastic Bag. 1 loaf
Food·49 affected·Oct 26, 2016
High RiskFDA
Pastian's Bakery
Home Wheat Texas Toast 1 lb. 8 oz. Clear Plastic Bag. 1 loaf
Food·62 affected·Oct 26, 2016
High RiskFDA
Pastian's Bakery
1 1/2 French Bread. 1lb. 8 oz.. Clear Plastic Bag. 1 loaf
Bakery & Grains·50 affected·Oct 26, 2016
High RiskFDA
Fanega Mexican Food Products, Inc.
10" Flour Tortillas 12 count, Net Wt. 25oz (732g)
Food·280 affected·Oct 26, 2016
High RiskFDA
Pastian's Bakery
Pumpernickle Bread. 1 lb. 8 oz. Clear Plastic Bag. 1 loaf
Bakery & Grains·1 affected·Oct 26, 2016
High RiskFDA
Pastian's Bakery
Extra Sourdough Bread-2 Squares. 32 oz. Clear Plastic Bag. 1 loaf
Bakery & Grains·0 affected·Oct 26, 2016
High RiskFDA
Pastian's Bakery
Extra Sourdough Bread. 32 oz. Clear Plastic Bag. 1 loaf
Bakery & Grains·6 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavi...
Surgical Devices·2,172 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the...
Surgical Devices·5,055 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the ...
Surgical Devices·4,836 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the c...
Surgical Devices·1,617 affected·Oct 26, 2016
High RiskFDA
Chesterman Co
A&W Cream Soda, 20 FL OZ, Caffeine Free
Dairy·1,010 affected·Oct 25, 2016
High RiskFDA
Beckman Coulter Inc.
MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility ...
Medical Devices·131 affected·Oct 25, 2016
High RiskFDA
Trumpf Medical Systems, Inc.
OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 ...
Medical Devices·4 affected·Oct 25, 2016
High RiskFDA
Burel Pharmaceuticals Inc
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, ...
Oral Drugs·35,149 affected·Oct 24, 2016