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High RiskFDA
Safe N Simple, Llc
DermaPro Waterproof Silicone Tape, SNS57232
Medical Devices·318 affected·Dec 14, 2017
High RiskFDA
Dynavox Systems Llc
Dynavox T15 Speech Generating Device ( including Batteries)
Medical Devices·307 affected·Dec 14, 2017
High RiskFDA
Kalila Medical
Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf ...
Medical Devices·261 affected·Dec 14, 2017
High RiskFDA
Merit Medical Systems, Inc.
PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, P...
Medical Devices·60,945 affected·Dec 14, 2017
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial...
Medical Devices·127 affected·Dec 14, 2017
High RiskFDA
Harrisburg Dairies, Inc
365 brand Egg Nog, Grade A; 1 qt. and 1/2 GAL; and Harrisburg Dairies brand Egg Nog, Grade A; 1/2 GAL, 1 Quart, 16 FL. OZ.
Food·14,134 affected·Dec 13, 2017
High RiskFDA
Allergan
INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), ...
Injectable Drugs·163,694 affected·Dec 13, 2017
High RiskFDA
Covidien Llc
Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads ...
Medical Devices·2,121 affected·Dec 13, 2017
High RiskFDA
C.r. Bard, Inc.
Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
Surgical Devices·0 affected·Dec 13, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of ...
Medical Devices·0 affected·Dec 13, 2017
High RiskFDA
Ii - Vi Incorporated
11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
Medical Devices·323,972 affected·Dec 13, 2017
High RiskFDA
Spice Chain Corporation
Paprika PAPA 12/5oz, International Bazaar
Food·8,148 affected·Dec 12, 2017
High RiskFDA
Spice Chain Corporation
Paprika Powder HyTop 12/2.5oz, Merchants
Food·2,128 affected·Dec 12, 2017
High RiskFDA
Spice Chain Corporation
Paprika Powder Guaranteed Value 12/2.75oz, C&S Distribution
Food·4,024 affected·Dec 12, 2017
High RiskFDA
Spice Chain Corporation
Paprika Sweet American Garden 12/3.25oz, Global Food Export
Food·1,043 affected·Dec 12, 2017
High RiskFDA
Spice Chain Corporation
Paprika HUN Kalosca 12/5o, World Finer Foods
Food·20,771 affected·Dec 12, 2017
High RiskFDA
Spice Chain Corporation
Paprika Hun Budapest 12/5oz, World Finer Foods
Food·1,822 affected·Dec 12, 2017
High RiskFDA
Spice Chain Corporation
Paprika Lowes 12/2.5oz, Topco
Food·58 affected·Dec 12, 2017
High RiskFDA
Spice Chain Corporation
Paprika Powder Krasdale 12/2.75oz, Krasdale
Food·2,318 affected·Dec 12, 2017
High RiskFDA
Spice Chain Corporation
Paprika Powder Shopper's Value 12/2.75oz, SuperValue
Food·1,678 affected·Dec 12, 2017
High RiskFDA
Woodfield Pharmaceutical, Llc
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arli...
Oral Drugs·15,707 affected·Dec 12, 2017
High RiskFDA
Boston Scientific Corporation
Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establ...
Surgical Devices·3,762 affected·Dec 12, 2017
High RiskFDA
Encore Medical, Lp
EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
Medical Devices·2 affected·Dec 12, 2017
High RiskFDA
Boston Scientific Corporation
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is...
Surgical Devices·2,614 affected·Dec 12, 2017
High RiskFDA
Boston Scientific Corporation
Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended ...
Surgical Devices·1,480 affected·Dec 12, 2017
High RiskFDA
Encore Medical, Lp
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
Medical Devices·2 affected·Dec 12, 2017
High RiskFDA
Lovejoy Bakers Inc
Rosemary Poppyseed crackers, net wt. 6 oz., packaged in clear poly bag with a twist tie. No UPC code. The label is read in parts: "***...
Dairy·6 affected·Dec 11, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT P...
Medical Devices·2 affected·Dec 11, 2017
High RiskFDA
Sanofi Genzyme
Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing...
Medical Devices·12,380 affected·Dec 11, 2017
High RiskFDA
Medical Action Industries Inc
Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel produc...
Medical Devices·31,440 affected·Dec 11, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Medical Devices·22 affected·Dec 11, 2017
High RiskFDA
Boston Scientific Corporation
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit th...
Surgical Devices·31,005 affected·Dec 11, 2017
High RiskFDA
Ams Llc Dba Gagne Foods
Sensations cinnamon roll UNCOOKED DOUGH 450g, UPC: 236821197
Food·37 affected·Dec 8, 2017
High RiskFDA
Heidelberg Engineering
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Medical Devices·382 affected·Dec 8, 2017
High RiskFDA
Datex-ohmeda, Inc.
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanica...
Respiratory Devices·349 affected·Dec 8, 2017
High RiskFDA
Abbott Laboratories, Inc
ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments wit...
Medical Devices·3,357 affected·Dec 8, 2017
High RiskFDA
Zimmer Biomet, Inc.
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Medical Devices·12 affected·Dec 8, 2017
High RiskFDA
Abbott Laboratories, Inc
ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with...
Medical Devices·3,634 affected·Dec 8, 2017
High RiskFDA
Hitachi Ltd., Medical System Operations Group
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions...
Medical Devices·1 affected·Dec 8, 2017
High RiskFDA
Ventura Foods, Llc
Sysco Imperial Glazed Hot Bacon Dressing; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas 77077; Code: B12917
Food·24 affected·Dec 7, 2017
High RiskFDA
Ventura Foods, Llc
Sysco Imperial Tartar Sauce; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas 77077; Code: 12817; Classic Gou...
Food·110 affected·Dec 7, 2017
High RiskFDA
World Finer Foods, Inc.
Rapunzel Vegetable Bouillon ( no added salt ), 2.4 oz. net weight, in a thick paper sleeve containing 8 foil-wrapped bouillon cubes, 12 u...
Produce·20,550 affected·Dec 7, 2017
High RiskFDA
Ventura Foods, Llc
Classic Gourmet Dressing; Country French; Net Wt 1.5 OZ.; Ventura Foods, LLC, Lot codes: 33317; Culinary Secrets Country French Dressing;...
Food·0 affected·Dec 7, 2017
High RiskFDA
Ventura Foods, Llc
A&W All American Food Papa Sauce; 8/24 OZ. Pouches; Net Wt 12 LB. Paced Exclusively For Use By: A&W and its franchisees., Lexington, KY 4...
Food·63 affected·Dec 7, 2017
High RiskFDA
Ventura Foods, Llc
Smokehouse 220 Sweet & Spicy Barbecue Sauce; Net Wt. 16 OZ.; Ventura Foods, Brea, CA 92823; Coded: 05 30 18.
Food·1,140 affected·Dec 7, 2017
High RiskFDA
Ventura Foods, Llc
plastic cup with foil seal: House Recipe Bleu Cheese Dressing & Dip; Distributed by: Sysco Corporation, Houston, Texas 77077; Net Wt 1.5...
Dairy·18 affected·Dec 7, 2017
High RiskFDA
Ventura Foods, Llc
Single-serve plastic pack: Newman's Own Lite Sesame Ginger; Net Wt. 1.5 OZ.; Produced exclusively for Newman's Own, Inc., Westport CT ...
Produce·38 affected·Dec 7, 2017
High RiskFDA
Ventura Foods, Llc
plastic cup with foil seal: House Recipe Ranch Dressing & Dip; Distributed by: Sysco Corporation, Houston, Texas 77077; Net Wt 1.5 OZ.Co...
Food·117 affected·Dec 7, 2017