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High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn
Medical Devices·840 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
Medical Devices·216 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn
Medical Devices·5,000 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn
Medical Devices·36 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn
Medical Devices·48 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
Medical Devices·288 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn
Medical Devices·430 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
Medical Devices·40 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn
Medical Devices·162 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa
Medical Devices·180 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa
Medical Devices·70 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
Cardiac Devices·30 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn
Medical Devices·1,056 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn
Medical Devices·1,224 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa Rosa
Medical Devices·55 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa
Medical Devices·148 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU
Medical Devices·14 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper
Medical Devices·10 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn
Cardiac Devices·228 affected·Jan 9, 2017
High RiskFDA
Laerdal Medical Corporation
Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ...
Medical Devices·4,377 affected·Jan 8, 2017
High RiskFDA
Olympus Scientific Solutions Americas
Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
Medical Devices·74 affected·Jan 7, 2017
High RiskFDA
Harris Teeter
Everroast Chicken Caesar Wrap, UPC: 72036-95828, in clear flexible plastic.
Meat & Poultry·0 affected·Jan 6, 2017
High RiskFDA
The Dannon Company, Inc.
DANONE¿ DAIRY DRINK NUT AND CEREAL 7.7 FL OZ (229mL) bottles, UPC 36632 01421
Dairy·49,360 affected·Jan 6, 2017
High RiskFDA
Hitachi Medical Systems America Inc
Hitachi Oasis MRI System - C-Spine Coil
Medical Devices·180 affected·Jan 6, 2017
High RiskFDA
The See Clear Company
Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Cl...
Medical Devices·119,829 affected·Jan 6, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Medical Devices·345 affected·Jan 6, 2017
High RiskFDA
C2 Therapeutics, Inc.
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected p...
Surgical Devices·755 affected·Jan 6, 2017
High RiskFDA
Innovagel
Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami,...
Oral Drugs·7,920,177 affected·Jan 5, 2017
High RiskFDA
Innovagel
Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186...
Oral Drugs·9,992,768 affected·Jan 5, 2017
High RiskFDA
The Harvard Drug Group
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500...
Oral Drugs·914 affected·Jan 5, 2017
High RiskFDA
The Harvard Drug Group
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500...
Oral Drugs·2,341 affected·Jan 5, 2017
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.,...
Oral Drugs·22,915 affected·Jan 5, 2017
High RiskFDA
Haag-streit Usa Inc
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Medical Devices·163 affected·Jan 5, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro ...
Diagnostic Devices·11,963 affected·Jan 4, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic...
Diagnostic Devices·9,076 affected·Jan 4, 2017
High RiskFDA
Endologix
AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-8...
Medical Devices·832 affected·Jan 4, 2017
High RiskFDA
Zimmer Biomet, Inc.
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item N...
Medical Devices·15,000 affected·Jan 4, 2017
High RiskFDA
Baxter Healthcare Corporation
Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemo...
Medical Devices·256 affected·Jan 4, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic us...
Diagnostic Devices·1,148 affected·Jan 4, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test ...
Diagnostic Devices·76,107 affected·Jan 4, 2017
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured,...
Medical Implants·619 affected·Jan 3, 2017
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to ...
Surgical Devices·619 affected·Jan 3, 2017
High RiskFDA
Allen Medical Systems, Inc.
Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is int...
Surgical Devices·112 affected·Jan 3, 2017
High RiskFDA
Seiler Instr. & Mfg. Co. Inc.
Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
Medical Devices·43 affected·Jan 1, 2017
High RiskFDA
Standex Intl Corp
Standex International Bakers Pride Microwave Ovens Model E300
Medical Devices·149 affected·Jan 1, 2017
High RiskFDA
Hospira Inc., A Pfizer Company
Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as pare...
Medical Devices·62,847 affected·Dec 30, 2016
High RiskFDA
Pittsburgh Spice & Seasoning Co
Pittsburgh Spice Co; Buffalo Wing Sausage, 20.25 OZ for 25 #; 1235 Clairhaven St, Pittsburgh, PA 15205
Food·34 affected·Dec 28, 2016
High RiskFDA
The Two Little Guys Company
Joe Chips Retro Potato Chips Sour Cream & Toasted Onion Distributed by: The Joe Tea Company, Upper Montclair, NJ 07043-0255 (973)744-75...
Dairy·70,130 affected·Dec 28, 2016