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High RiskFDA
Intuitive Surgical, Inc.
8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·5 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Zimmer Cas
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is ...
Medical Implants·15 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Bard Access Systems
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
Medical Devices·2,532 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Nature's Way Purewater Systems, Inc.
ESSENTIA Hydration Perfected Purified Water and Electrolytes, 9.5 pH, Manufactured for Essentia Water Inc., 22833 Bothell Evrt Hwy, Bot...
Beverages·1 affected·Oct 31, 2014
High RiskFDA
Accuray Incorporated
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for tr...
Medical Devices·84 affected·Oct 31, 2014
High RiskFDA
Us Endoscopy Group Inc
UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corru...
Medical Devices·100 affected·Oct 31, 2014
High RiskFDA
King & Prince Seafood
MRS FRIDAY'S GOURMET BREADED MEDIUM OYSTERS 18/25 CT/LB, Net Wt. 2.5 lbs (1.13 kg), Ready to Fry, Distributed by: King and Prince Seafood...
Seafood·518 affected·Oct 30, 2014
High RiskFDA
Baxter Healthcare Corp.
Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for B...
Injectable Drugs·127,746 affected·Oct 30, 2014
High RiskFDA
Carestream Health, Inc.
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Medical Devices·59 affected·Oct 30, 2014
High RiskFDA
Alcon Research, Ltd.
INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082,...
Medical Devices·147,473 affected·Oct 30, 2014
High RiskFDA
Mt. Olive Pickle Company Inc
Mt. Olive, Kosher Dill Chips in 1 gallon glass jars, UPC 09300 12841, Mt. Olive, Corner of Cucumber & Vine, P.O. Box 609, Mt Olive, NC 28...
Snacks & Candy·40,532 affected·Oct 29, 2014
High RiskFDA
Remel Inc
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a...
Medical Devices·79 affected·Oct 29, 2014
High RiskFDA
Synthes, Inc.
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the ...
Medical Devices·6 affected·Oct 29, 2014
High RiskFDA
Cooper Vision Caribbean Corp.
Soft Contact Lens
Medical Devices·1,170 affected·Oct 28, 2014
High RiskFDA
Saxon Cheese, Llc
Saxon Creamery Greenfields Monastery Washed Rind Wisconsin Handcrafted Cheese, 7 lb wheel. Ingredients: Pasteurized Cow's Milk, culture, ...
Dairy·458 affected·Oct 27, 2014
High RiskFDA
Kent Precision Foods Group, Inc.
Chicken flavored broth base and seasoning, low sodium sold under the Orrington Farms brand in 5 oz. plastic jars.
Meat & Poultry·13,572 affected·Oct 27, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as a...
Diagnostic Devices·3,622 affected·Oct 27, 2014
High RiskFDA
Straumann Usa, Llc
Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
Medical Implants·362 affected·Oct 27, 2014
High RiskFDA
Arthrocare Medical Corporation
Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Int...
Medical Devices·23,119 affected·Oct 27, 2014
High RiskFDA
Tristar Food Wholesale Co Inc
Bar Guo Food Preserved Plum Candy, Net Wt. 8 oz. (228g), Packaged in a Cellophane Bag, Product of China: Tristar Food Wholesale Inc., NJ
Snacks & Candy·20 affected·Oct 24, 2014
High RiskFDA
Exotic Superfoods New York, Inc.
Exotic Superfoods 100% Raw Young Thai Coconut Water, 32 oz. SKU: 7 05105 50171 0 Exotic Superfoods 100% Raw Young Thai Coconut Water...
Beverages·343,592 affected·Oct 24, 2014
High RiskFDA
Carefusion 213, Llc
Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25
Drugs·20,556,000 affected·Oct 24, 2014
High RiskFDA
Hospira Inc.
Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India fo...
Injectable Drugs·261,706 affected·Oct 24, 2014
High RiskFDA
Ge Healthcare
GE Discovery MR950 MRI system
Medical Devices·5 affected·Oct 24, 2014
High RiskFDA
Discus Dental Llc
Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 p...
Medical Devices·20,251 affected·Oct 24, 2014
High RiskFDA
Coca-cola Company (the)
Odwalla Chocolate Protein Shake, 15.2 fl. oz, and 32 fl. oz bottles, Distributed by: Odwalla, Inc., Dinuba, CA 93618.
Snacks & Candy·30,390 affected·Oct 23, 2014
High RiskFDA
Coca-cola Company (the)
Odwalla Vanilla Almondo Protein, 15.2 fl. oz bottles, Distributed by: Odwalla, Inc., Dinuba, CA 93618.
Food·0 affected·Oct 23, 2014
High RiskFDA
Centurion Medical Products Corporation
Diagnostic Imaging Tray (General Surgery convenience kit)
Diagnostic Devices·760 affected·Oct 23, 2014
High RiskFDA
Jas Diagnostics Inc.
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
Diabetes Devices·390 affected·Oct 23, 2014
High RiskFDA
Remel Inc
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pne...
Diagnostic Devices·59 affected·Oct 23, 2014
High RiskFDA
Data Innovations, Llc
JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that p...
Diagnostic Devices·657 affected·Oct 23, 2014
High RiskFDA
Abbott Molecular
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Medical Devices·9 affected·Oct 23, 2014
High RiskFDA
Tem Systems Inc
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Medical Devices·1,574 affected·Oct 23, 2014
High RiskFDA
Premier Research Labs Lp
Quantum Gallbladder Support, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each; Item Number 12411; UPC 0773512411
Food·7,101 affected·Oct 22, 2014
High RiskFDA
Premier Research Labs Lp
Premier Research Labs BiliVen, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each);Item Number 2411
Food·49,830 affected·Oct 22, 2014
High RiskFDA
Prometheus Laboratories Inc.
Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured b...
Oral Drugs·16,296 affected·Oct 22, 2014
High RiskFDA
Stryker Neurovascular
Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial a...
Surgical Devices·1 affected·Oct 22, 2014
High RiskFDA
Los Chileros De Nuevo Mexico, Ltd
Los Chileros de nuevo mexico gourmet southwestern cuisine Santa Fe Chile Seasoning, 4.5oz (127.6 grams), Los Chileros de Nuevo Mexico, P...
Food·1,977 affected·Oct 21, 2014
High RiskFDA
Health Wise
Vanilla Pro-Med. 100, Vanilla Pro, High Protein Instant Shake, Net Weight .0935 oz, Distributed by Our Life Health, Savannah, GA
Food·12,196 affected·Oct 21, 2014
High RiskFDA
Giorgio Foods Inc
Bulk packed Wheat Cheese Calzone 48 Servings KEEP FROZEN NET WEIGHT 15.00 lbs Inspected By The U.S. Dept of Agriculture Distributed ...
Dairy·127 affected·Oct 21, 2014