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High RiskFDA
Zimmer Biomet, Inc.
Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization an...
Medical Devices·50 affected·Nov 20, 2018
High RiskFDA
Pharm D Solutions, Llc
Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1...
Drugs·85 affected·Nov 19, 2018
High RiskFDA
Heartware, Inc.
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System ...
Cardiac Devices·2,031 affected·Nov 19, 2018
High RiskFDA
Randox Laboratories Ltd.
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprot...
Diagnostic Devices·250 affected·Nov 19, 2018
High RiskFDA
Arthrex, Inc.
Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Nu...
Medical Devices·1,308 affected·Nov 19, 2018
High RiskFDA
Tillamook County Creamery Assoc
Chocolaty Chip Cookie Dough ice cream (item #67016), packaged in 1.75 qt. container. UPC 0 72830 07016 4. The label is read in parts: ...
Dairy·5,362 affected·Nov 16, 2018
CriticalFDA
Chukar Cherry Company
Organic Ultra Dark Orange Chocolate Tart Cherries, Chukar Cherries brand, packaged in 7.5 oz. plastic pouches. UPC 0 11261 27207 5. Th...
Dairy·190 affected·Nov 16, 2018
High RiskFDA
Tillamook County Creamery Assoc
Tillamook Mudslide ice cream (item #63006), packaged in 3 gallon tub. UPC 0 72830 63006 1. The label is read in parts: "***TILLAMOOK M...
Dairy·106 affected·Nov 16, 2018
High RiskFDA
Tillamook County Creamery Assoc
Udderly Chocolate ice cream (item #67045), packaged in 1.75 qt. container. UPC 0 72830 07045 4. The label is read in parts: "***Tillam...
Dairy·6,754 affected·Nov 16, 2018
High RiskFDA
Tillamook County Creamery Assoc
Vanilla Chocolate Chip ice cream (item #67017), packaged in 1.75 qt. container. UPC 0 72830 07017 1. The label is read in parts: "***T...
Dairy·11,306 affected·Nov 16, 2018
CriticalFDA
Marich Confectionery Company, Inc.
Milk Chocolate Maltballs: NET Wt. 15 lbs. Item number 992 Case UPC 00797817-00992-9 Allergy Information: This product contains Whea...
Dairy·324 affected·Nov 16, 2018
CriticalFDA
Chukar Cherry Company
Ultra Dark Chocolate Black Forest Cherries, Chukar Cherries brand, packaged in 7.5 oz. plastic pouches. UPC 0 11261 23907 8. The label...
Dairy·2,098 affected·Nov 16, 2018
CriticalFDA
Chukar Cherry Company
Organic Ultra Dark Vanilla Chocolate Rainier Cherries, Chukar Cherries brand, packaged in 7.5 oz. plastic pouches. UPC 0 11261 27207 5. ...
Dairy·502 affected·Nov 16, 2018
CriticalFDA
Chukar Cherry Company
Ultra Dark Chocolate Cocoa Pecans, Chukar Cherries brand, packaged in 7.5 oz. plastic pouches. UPC 0 11261 22507 1. The label is read ...
Dairy·569 affected·Nov 16, 2018
CriticalFDA
Chukar Cherry Company
Ultra Dark Chocolate Amaretto Rainier Cherries, Chukar Cherries brand, packaged in 7.5 oz. plastic pouches. UPC 0 11261 22307 7.
Snacks & Candy·1,316 affected·Nov 16, 2018
CriticalFDA
Agropur Msi Ingredients Llc
Jay Robb Unflavored Egg White Protein, Net Weight 24 oz (1.5lbs) 680g. Dietary Supplement. UPC 03907-00492. Jay Robb, Inc., Jupiter, F...
Supplements·1,956 affected·Nov 16, 2018
High RiskFDA
Cao Group, Inc.
SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 8...
Drugs·71 affected·Nov 16, 2018
High RiskFDA
Cao Group, Inc.
fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco...
Topical Drugs·115 affected·Nov 16, 2018
High RiskFDA
Cao Group, Inc.
FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk ...
Topical Drugs·602 affected·Nov 16, 2018
High RiskFDA
Cao Group, Inc.
BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded ...
Topical Drugs·803 affected·Nov 16, 2018
RecallFDA
Ascension Orthopedics, Inc
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Medical Implants·0 affected·Nov 16, 2018
CriticalFDA
Invacare Corporation
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lif...
Medical Devices·73,703 affected·Nov 16, 2018
High RiskFDA
Livanova Usa Inc
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Medical Devices·643 affected·Nov 16, 2018
High RiskFDA
Livanova Usa Inc
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and exte...
Medical Implants·9,282 affected·Nov 16, 2018
High RiskFDA
Livanova Usa Inc
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vag...
Medical Devices·745 affected·Nov 16, 2018
High RiskFDA
4patriots, Llc
4Patriots Chicken a la King CONTAINS: Wheat, Coconut NET WT. 10.0 oz (284 g)
Meat & Poultry·5,453 affected·Nov 15, 2018
High RiskFDA
Harris Teeter Supermarkets, Llc Dba Hunter Farms
TURKEY HILL Vanilla Bean Premium Ice Cream #501 3 GAL (11.36L) paper carton CONTAINS: MILK Distributed By: Turkey Hill Dairy 2601 River R...
Dairy·866 affected·Nov 15, 2018
CriticalFDA
Fresenius Kabi Usa, Llc
SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, I...
Injectable Drugs·1,312,350 affected·Nov 15, 2018
CriticalFDA
Fresenius Kabi Usa, Llc
SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, I...
Injectable Drugs·23,745,300 affected·Nov 15, 2018
High RiskFDA
Howmedica Osteonics Corp.
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
Medical Devices·0 affected·Nov 15, 2018
High RiskFDA
Covidien Llc
Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and i...
Medical Devices·0 affected·Nov 15, 2018
High RiskFDA
Philips Electronics North America Corporation
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 4535644...
Medical Devices·651 affected·Nov 15, 2018
High RiskFDA
Covidien Llc
Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, ...
Medical Devices·0 affected·Nov 15, 2018
High RiskFDA
Covidien Llc
Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic,...
Medical Devices·0 affected·Nov 15, 2018
High RiskFDA
Prollenium Medical Technologies Inc.
Revanesse Versa, PN40081
Medical Devices·48,457 affected·Nov 15, 2018
High RiskFDA
Vital Scientific N.v.
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Medical Devices·732 affected·Nov 15, 2018
CriticalFDA
Harb Dairy, Inc. Dba Green Cedar Dairy
Green Cedar Ackawi cheese in small clear plastic shrink wrapped packaging bearing a sell by date of March 26, 2019 or later. The sell ...
Dairy·0 affected·Nov 14, 2018
High RiskFDA
Ascend Laboratories Llc
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distribut...
Oral Drugs·0 affected·Nov 14, 2018
High RiskFDA
Swissray Medical Ag
ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, mul...
Medical Devices·3 affected·Nov 14, 2018
High RiskFDA
Diagnostica Stago, Inc.
Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of ...
Diagnostic Devices·22,342 affected·Nov 14, 2018
High RiskFDA
In2bones Usa, Llc
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
Medical Devices·30 affected·Nov 14, 2018
High RiskFDA
Zimmer Biomet, Inc.
Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stab...
Medical Devices·64 affected·Nov 14, 2018
CriticalFDA
Quaker Manufacturing, Llc
Cap'n Crunch's Peanut Butter Crunch Cereal packaged in 17.1 ounce and 16.5 ounce cardboard boxes. Distributed by The Quaker Oats Company,...
Dairy·108 affected·Nov 13, 2018
High RiskFDA
Tom Sturgis Pretzels, Inc.
Little Ones Pretzels¿ 4.5lb, 1 polyethylene bag per corrugated container .
Food·80 affected·Nov 13, 2018
High RiskFDA
Smartypants Vitamins
Smartypants Kids Complete, Non GMO Multi and omega 3's vitamin D3 for bones, vitamin B12 for Energy: 90 gummies. UPC 8 5136 00425 5 ...
Supplements·60,726 affected·Nov 13, 2018
CriticalFDA
Nor Cal Food Solutions Llc
Purveyors Kitchen Pumpkin Pesto Tapenade; NET WT 7.75 oz. (220G) UPC: 0 37677 01624 9 Ingredients: Water, Pumpkin, Basil, Parsley, C...
Dairy·567 affected·Nov 13, 2018
High RiskFDA
Thatchers Gourmet Specialties Inc.
Gingerbread Popcorn. 8 ounce (227 grams) flexible plastic bag. Brand name of Disney Theme Park Merchandise or Disney Parks Distributed...
Bakery & Grains·2,898 affected·Nov 13, 2018
High RiskFDA
Biomerieux, Inc.
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Medical Devices·5 affected·Nov 13, 2018