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High RiskFDA
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Medical Devices·81 affected·Apr 8, 2016
High RiskFDA
Limacorporate S.p.a
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Medical Implants·314 affected·Apr 8, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by compute...
Medical Devices·424 affected·Apr 8, 2016
High RiskFDA
Union Bagel Shop
Package contains a business card for "***BAGEL SHOP***" "***Sesame Seed: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, ...
Beverages·0 affected·Apr 7, 2016
High RiskFDA
Union Bagel Shop
Package contains a business card for "***BAGEL SHOP***" "***CINNAMON RAISIN*** Filtered Water, Sea Salt, Olive Oil, Sugar, Flour, Yeas...
Dairy·0 affected·Apr 7, 2016
High RiskFDA
Salsa Dianne
Classic Pesto Sauce (with a twist), net wt. 4 oz. (113 g). Product is packaged in a round Styrofoam containers with translucent plastic l...
Dairy·0 affected·Apr 7, 2016
High RiskFDA
Spice Chain
Rose Red Organic Ginger Steam Filter Bag & Organic Ground Ginger Steam packaged in a poly-lined corrugated carton; 40 lb case bulk pack ...
Food·5,240 affected·Apr 7, 2016
High RiskFDA
Union Bagel Shop
Package contains a business card for "***BAGEL SHOP***" "***Double Cheese: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt...
Dairy·0 affected·Apr 7, 2016
High RiskFDA
Union Bagel Shop
Package contains a business card for "***BAGEL SHOP***" "***Cinnamon Raisin: Flour, Filtered Water, Organic Shortening, Olive Oil, Ma...
Beverages·0 affected·Apr 7, 2016
High RiskFDA
Union Bagel Shop
Package contains a business card for "***BAGEL SHOP***" "***Jalapeno Cheddar: Flour, Filtered Water, Organic Shortening, Olive Oil, M...
Dairy·0 affected·Apr 7, 2016
High RiskFDA
Union Bagel Shop
Package contains a business card for "***BAGEL SHOP***" "***CINNAMON SWIRL***Filtered Water, Sea Salt, Olive Oil, Sugar, Flour, Yeast,...
Dairy·0 affected·Apr 7, 2016
High RiskFDA
Union Bagel Shop
Package contains a business card for "***BAGEL SHOP***" "***JALAPENO BREAD *** Filtered Water,Sea Salt, Olive Oil, Sugar, Flour, Yeas...
Dairy·0 affected·Apr 7, 2016
High RiskFDA
Union Bagel Shop
Package contains a business card for "***BAGEL SHOP***" "***Bacon Cheddar: Flour, Filtered Water, Organic Shortening, Bacon Bits, Che...
Dairy·0 affected·Apr 7, 2016
High RiskFDA
Union Bagel Shop
Package contains a business card for "***BAGEL SHOP***" "***Onion/Garlic: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt,...
Beverages·0 affected·Apr 7, 2016
High RiskFDA
Union Bagel Shop
Package contains a business card for "***BAGEL SHOP***" "***Italian: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Suga...
Beverages·0 affected·Apr 7, 2016
High RiskFDA
Michel Et Augustin Inc
Michel et Augustin brand Petites baguettes butter cookies Dark Chocolate with a pinch of salt, NET WT. 1.58 oz (45g), UPC 81266802016, Pr...
Dairy·2,408 affected·Apr 7, 2016
High RiskFDA
Union Bagel Shop
Package contains a business card for "***BAGEL SHOP***" "***10-GRAIN BREAD***Filtered Water, Sea Salt, Olive Oil, Sugar, Flour, Whole ...
Dairy·0 affected·Apr 7, 2016
High RiskFDA
Union Bagel Shop
Package contains a business card for "***BAGEL SHOP***" "***Plain: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar,...
Beverages·0 affected·Apr 7, 2016
High RiskFDA
Akorn, Inc.
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by ...
Ophthalmic Drugs·10,060 affected·Apr 7, 2016
High RiskFDA
Pentax Medical Company
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. T...
Medical Implants·0 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes...
Medical Implants·4,195 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includ...
Medical Implants·12,412 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult trachea...
Medical Implants·1,220 affected·Apr 6, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (re...
Medical Devices·5,600 affected·Apr 6, 2016
High RiskFDA
Skytron, Div. The Kmw Group, Inc
EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ...
Surgical Devices·458 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. T...
Medical Implants·12,412 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus...
Medical Implants·96 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds....
Medical Implants·206 affected·Apr 6, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative meas...
Diagnostic Devices·218 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic acce...
Medical Implants·819 affected·Apr 6, 2016
High RiskFDA
Nuvectra
Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems....
Medical Implants·17 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy inclu...
Medical Implants·1,596 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmona...
Medical Implants·115 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Ga...
Medical Implants·819 affected·Apr 6, 2016
High RiskFDA
Pentax Medical Company
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. T...
Medical Implants·10,074 affected·Apr 6, 2016
High RiskFDA
Wise Foods Inc
Cha-Ching Original Potato Chips Net Wt 10 OZ.; Distributed by OZA Brands, LLC, Salisbury, NC 28147
Snacks & Candy·400 affected·Apr 5, 2016
High RiskFDA
Fresenius Kabi Usa, Llc
Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius ...
Injectable Drugs·94,560 affected·Apr 5, 2016
High RiskFDA
Ceg Enterprises Llc
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manua...
Medical Devices·100,548 affected·Apr 5, 2016
High RiskFDA
Leica Microsystems, Inc.
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
Medical Devices·90 affected·Apr 5, 2016
High RiskFDA
Vaughan Foods
La Fiesta Bean Salad (2/5 LB Tubs) Made By Fresh Creative Foods Moore, OK 73160 UPC 013454371763 packaged in white plastic tub with lid
Produce·126 affected·Apr 4, 2016
High RiskFDA
Keystone Laboratories Inc
BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEY...
Drugs·7 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Medical Devices·1,627 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physio...
Cardiac Devices·24 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software.
Medical Devices·217 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and rec...
Cardiac Devices·2 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures...
Cardiac Devices·219 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Medical Devices·333 affected·Apr 4, 2016
High RiskFDA
Synthes (usa) Products Llc
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
Medical Implants·15 affected·Apr 4, 2016