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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
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
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
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
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
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
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
High RiskFDA
Stryker Communications
EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0...
Surgical Devices·3,176 affected·Nov 13, 2018
High RiskFDA
Advocare International, Lp
SleepWorks Liquid Vitamin & Mineral Herbal Supplement 12 single serving bottles - 2 Fl Oz (60 mL) Net 24 Fl Oz (720 mL), product code W3721
Supplements·53,205 affected·Nov 12, 2018
High RiskFDA
Raysearch Laboratories Ab
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
Medical Devices·69 affected·Nov 12, 2018
High RiskFDA
Bracco Injeneering S.a.
Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Syste...
Medical Devices·33,350 affected·Nov 12, 2018
High RiskFDA
Hart Freeze Pack, Llc
Pictsweet Farms Steam'ables Asparagus Spears 8oz. pouch, 10 per case UPC 0 70560 97799 9 Frozen
Frozen Food·2,794 affected·Nov 9, 2018
High RiskFDA
Sargento Foods, Inc.
Frozen Unbreaded Egg, Gouda, caramelized onion. Sample Number 18-0116.01. Keep Frozen at 0-degrees or below zero. "Food for Research o...
Bakery & Grains·12 affected·Nov 9, 2018
High RiskFDA
Sargento Foods, Inc.
Frozen Unbreaded Egg, 3 Cheese and caramelized onion. Sample Number 18-0115.01. Keep Frozen at 0-degrees or below zero. "Food for Rese...
Dairy·12 affected·Nov 9, 2018
High RiskFDA
Chicago Importing Co
Finax Muesli with 45% Fruit; 22.9-oz.; Heat sealed plastic bag; 10 bags/case
Produce·2,700 affected·Nov 9, 2018
High RiskFDA
Sargento Foods, Inc.
Frozen Unbreaded French onion / Swiss and Onion CC. Sample Number 17-0160.01. Keep Frozen at 0-degrees or below zero. "Food for Resear...
Bakery & Grains·16 affected·Nov 9, 2018
High RiskFDA
Ecolab Inc
Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN ...
Drugs·12,540 affected·Nov 9, 2018
High RiskFDA
Ecolab Inc
Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102,...
Drugs·14,108 affected·Nov 9, 2018
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, S...
Medical Devices·508 affected·Nov 9, 2018
High RiskFDA
Tekia, Inc.
TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., I...
Medical Devices·81 affected·Nov 9, 2018
High RiskFDA
Schwan's Global Supply Chain, Inc.
Schwan's Sea Salt Carmel Cashew Ice Cream (#206). Net Wt 56 oz.
Dairy·2,000 affected·Nov 8, 2018
High RiskFDA
Black River Industries
Italian Spice Blend Salt Free in 2 Lb. plastic bottles and 20 Lb. bulk boxes. Ingredients; Basil, Rosemary, Oregano, Marjoram & Spices...
Food·22 affected·Nov 8, 2018
High RiskFDA
Black River Industries
Parsley Flakes in 6 oz. and 24 oz. plastic bottles and 20 lb boxes
Food·103 affected·Nov 8, 2018
High RiskFDA
Black River Industries
Sweet Basil Leaf in 2 Lb. plastic bottles and 25 pound bulk boxes.
Food·80 affected·Nov 8, 2018
High RiskFDA
Allergan
INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Path...
Injectable Drugs·111,132 affected·Nov 8, 2018
High RiskFDA
Icu Medical Inc
SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indi...
Medical Devices·31,050 affected·Nov 8, 2018
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Sri...
Oral Drugs·4,212 affected·Nov 7, 2018
High RiskFDA
Hager & Meisinger Gmbh
Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/1...
Medical Devices·2,500 affected·Nov 7, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Diagnostic Devices·146 affected·Nov 7, 2018