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Recall Observatory FDA recall evidence

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Recalled products

The canonical enforcement rows. Everything else groups, enriches, or interprets these records.

Indexed record set

86,536 products

Page 3434 of 3462

Product Firm Event Initiated
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment. Nidek Inc Event 70335 March 27, 2012
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye. Topcon Medical Laser Systems, Inc Event 65688 March 27, 2012
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation. Maquet Cardiovascular, LLC Event 62121 March 27, 2012
Jugos Naturales del Pepino, Jugo de China Natural (Natural Orange Juice), 1 Gal (128 oz), Este producto no est¿ pasteurizado (This product is not pasteurized), Carr 466 Km 4.7 Bo. Robles, San SEbastian, PR 00685 Jugos Naturales del Pepino, Inc. Event 61530 March 27, 2012
TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. Tango3 LLC Event 62514 March 26, 2012
Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole. B. Braun Medical, Inc. Event 63862 March 23, 2012
Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing. Colgate Palmolive Company Event 61670 March 23, 2012
Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration. B. Braun Medical, Inc. Event 62115 March 23, 2012
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures. Biomet 3i, LLC Event 62375 March 23, 2012
Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing. Colgate Palmolive Company Event 61670 March 23, 2012
Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing. Colgate Palmolive Company Event 61670 March 23, 2012
Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft UPC 03500068762 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing. Colgate Palmolive Company Event 61670 March 23, 2012
Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing. Colgate Palmolive Company Event 61670 March 23, 2012
Salsa in 12 oz., 16 oz., and 5 lb. plastic containers. The product labels reads as follows: PREMIUM QUALITY Private Selection Natural***SALSA NO PRESERVATIVES KEEP REFRIGERATED NET WT 12 OZ (340g)***INGREDIENTS: Tomatoes***Jalapeno***DISTRIBUTED BY: INTER-AMERICAN PRODUCTS, CINCINNATI, OHIO 45202***1-800-697-2448***" and PREMIUM QUALITY Private Selection Natural PICO DE GALLO NO PRESERVATIVES KEEP REFRIGERATED NET WT 12 OZ (340g)***INGREDIENTS: Tomatoes***Jalapeno***DISTRIBUTED BY: INTER-AMERICAN PRODUCTS, CINCINNATI, OHIO 45202***1-800-697-2448*** and heinens" Fresh***Salsa All Natural Net. Wt. 16oz. (1lb) 454g***Ingredients: Tomatoes***Jalapeno***PACKED FOR HEINENS BY CLUB CHEF, LLC and heinens" Fresh Bruschetta All Natural Net. Wt. 16oz. (1lb) 454g ***Ingredients: Tomatoes***Jalapeno***PACKED FOR HEINENS BY CLUB CHEF, LLC Club Chef LLC Event 61497 March 23, 2012
Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 Tripath Imaging, Inc. Event 61737 March 22, 2012
PrepStain Syringing Pipettes 240 (Catalog #490517) Tripath Imaging, Inc. Event 61737 March 22, 2012
PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240) Tripath Imaging, Inc. Event 61737 March 22, 2012
PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 Tripath Imaging, Inc. Event 61737 March 22, 2012
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 Tripath Imaging, Inc. Event 61737 March 22, 2012
Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device. Extremity Medical LLC Event 63805 March 22, 2012
Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12. Noven Pharmaceuticals, Inc. Event 62002 March 22, 2012
Dr. Mercola Miracle Whey Protein Powder, dietary supplement, packaged in 1-lb. bottles and packed 6/1 lb-bottles per case. Distributed by Mercola Health Resources, LLC, Aurora, IL. Defense Nutrition Event 61467 March 22, 2012
Defense Nutrition Organic Warrior Whey Powder, Plain, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case. Distributed by Defense Nutrition, Woodland Hills, CA. Defense Nutrition Event 61467 March 22, 2012
Defense Nutrition Warrior Whey Natural Powder, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case. Defense Nutrition Event 61467 March 22, 2012
DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070 Quadrant Chemical Corporation Event 61518 March 20, 2012

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