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High RiskFDA
Stryker Endoscopy
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the s...
Surgical Devices·2,591 affected·Apr 16, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with ...
Diagnostic Devices·49 affected·Apr 16, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and...
Medical Devices·2,461,824 affected·Apr 16, 2014
High RiskFDA
P&l Developments, Llc
Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl o...
Drugs·1,363,338 affected·Apr 15, 2014
High RiskFDA
Biomet, Inc.
EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic inst...
Surgical Devices·100 affected·Apr 15, 2014
High RiskFDA
Handicare Usa, Inc.
ReTurn 7500/7500 Aid, transfer
Medical Devices·29 affected·Apr 15, 2014
High RiskFDA
Cordis Corporation
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate ...
Surgical Devices·98 affected·Apr 15, 2014
High RiskFDA
Biomet, Inc.
EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through so...
Medical Devices·102 affected·Apr 15, 2014
High RiskFDA
Orange Peel Enterprises, Inc.
Greens+ Vegan Crisp Bars - Dark Chocolate Almond Coffee Crisp in 1.4 oz packages.
Snacks & Candy·117,036 affected·Apr 14, 2014
High RiskFDA
Golub Corporation
Price Chopper brand Hummus ROASTED GARLIC, NET WT. 10 OZ. Labels applied to clear plastic container with black rim on lid.
Food·72 affected·Apr 14, 2014
High RiskFDA
Orange Peel Enterprises, Inc.
Greens+ Vegan Crisp Bars - Dark Chocolate Almond Blueberry in 1.4 oz packages.
Snacks & Candy·117,036 affected·Apr 14, 2014
High RiskFDA
Orange Peel Enterprises, Inc.
Greens+ Vegan Crisp Bars - Dark Chocolate Peanut Butter in 1.4 oz packages.
Dairy·117,036 affected·Apr 14, 2014
High RiskFDA
Golden State Medical Supply Inc.
LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged ...
Oral Drugs·6,042 affected·Apr 14, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 0...
Drugs·14,496 affected·Apr 14, 2014
High RiskFDA
P&l Developments, Llc
Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, O...
Drugs·2,500,510 affected·Apr 14, 2014
High RiskFDA
Ivoclar Vivadent, Inc.
bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental cur...
Medical Devices·241 affected·Apr 14, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Medical Devices·0 affected·Apr 14, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count ...
Diabetes Devices·590,136 affected·Apr 14, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass proced...
Medical Devices·0 affected·Apr 14, 2014
High RiskFDA
Microline Surgical
Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips a...
Surgical Devices·540 affected·Apr 14, 2014
High RiskFDA
Tenex Health Inc
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the...
Surgical Devices·9,927 affected·Apr 14, 2014
High RiskFDA
Merit Medical Systems, Inc.
Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
Medical Devices·186 affected·Apr 14, 2014
High RiskFDA
American Pop Corn Co
Jolly Time Microwave popcorn, Extra Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton - UPC 0281900...
Dairy·148 affected·Apr 11, 2014
High RiskFDA
American Pop Corn Co
Jolly Time Microwave popcorn, Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton UPC 028190007876, o...
Dairy·3,394 affected·Apr 11, 2014
High RiskFDA
Blue Belt Technologies Mn
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Medical Devices·11 affected·Apr 11, 2014
High RiskFDA
Koogee-queen Anne, Llc
Banana Puddin' Y'all Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·3 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Mocha Almond Fudge Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·1 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Egg Noggin' Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·7 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Cake Batter Up Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·3 affected·Apr 10, 2014
High RiskFDA
The Pastene Companies Ltd.
Pastene ITALIAN FARFALLE #66 ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7...
Food·6,000 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Ze German Chocolate Cake Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·7 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Bonjour Toast Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·1 affected·Apr 10, 2014
High RiskFDA
The Pastene Companies Ltd.
Pastene ITALIAN PAPPARDELLE ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7092...
Food·6,000 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Raspberry Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Produce·1 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Chocolate Peanut Butter Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·2 affected·Apr 10, 2014
High RiskFDA
The Pastene Companies Ltd.
Pastene ITALIAN RIGATONI #31 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:...
Food·6,000 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Dulce de Leche de Salte Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·17 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Mexican Chocolate Ole Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·2 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Bourbon Maple Walnut Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·1 affected·Apr 10, 2014
High RiskFDA
The Pastene Companies Ltd.
Pastene ITAL LONG FUSILLI ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7098 ...
Food·6,000 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Minty Chocolate Chippy Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·12 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Jack and Cola Float Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·3 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Peaches and Cream Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·2 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Green Tea Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·2 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Ginger 2 Snaps Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·3 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Freshly Roasted Coffee Ice Cream and Policeman's Special Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Fra...
Dairy·3 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Shirley's Red Velvet Cake with Cheesecake Swirl Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Av...
Dairy·1 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Say "Cheeeeeesecake" Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·3 affected·Apr 10, 2014