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High RiskFDA
Ge Oec Medical Systems, Inc
OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluo...
Surgical Devices·0 affected·Dec 19, 2016
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
Medical Devices·4,657 affected·Dec 19, 2016
High RiskFDA
House-autry Mills, Inc
House-Autry Buttermilk Biscuit Mix Tote, Net Wt., 8 oz. (227 g.), UPC Code 0 73484 15500 9,
Dairy·1,217 affected·Dec 18, 2016
High RiskFDA
House-autry Mills, Inc
Buddy's Bar-B-Q Hushpuppy Mix, Net Wt., 5 lb bags, UPC Code 0 73484 22156 2,
Food·658 affected·Dec 18, 2016
High RiskFDA
House-autry Mills, Inc
Po Folks Cornbread Mix, Net Wt., 5 lb bags, UPC Code 0 73484 22509 2
Bakery & Grains·299 affected·Dec 18, 2016
High RiskFDA
House-autry Mills, Inc
Roy Roger's Pancake Mix, Net Wt., 2 lb. 8 oz. bags, UPC Code 0 73484 22724 0
Bakery & Grains·141 affected·Dec 18, 2016
High RiskFDA
House-autry Mills, Inc
House-Autry Cheese Biscuit Mix, Net Wt., 8 oz. (227 g.), UPC Code 0 73484 15510 8,
Dairy·987 affected·Dec 18, 2016
High RiskFDA
House-autry Mills, Inc
House Autry, stone Ground Buttermilk Corn Bread Mix, Net wt. 8 oz. boxes, UPC Code 0 73484 15512 2,
Dairy·1,456 affected·Dec 18, 2016
High RiskFDA
House-autry Mills, Inc
House-Autry Butterflake Biscuit Mix, Net Wt. 25 lb. bags, UPC Code 0 73484 20513 1,
Dairy·606 affected·Dec 18, 2016
High RiskFDA
Chesapeake Spice Company, Llc
GREEN BEAN SAUCE SEASONING NET WEIGHT: 50.00 LBS
Food·9,650 affected·Dec 16, 2016
High RiskFDA
Chesapeake Spice Company, Llc
ENCHILADA SEASONING NET WEIGHT: 50. 00 LBS
Food·7,500 affected·Dec 16, 2016
High RiskFDA
Berner Food & Beverage, Llc
Lite Creamy Alfredo, gluten free, Pasta Sauce; Glass jar, metal lid; NET WT. 15 OZ, CONT. NET 425g; UPC 41220898732
Food·1,224 affected·Dec 16, 2016
High RiskFDA
Berner Food & Beverage, Llc
Roasted Garlic Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 36800334779
Food·70 affected·Dec 16, 2016
High RiskFDA
Berner Food & Beverage, Llc
Creamy Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 41220845941, 70038626695 or 041498172855
Food·1,149 affected·Dec 16, 2016
High RiskFDA
Chesapeake Spice Company, Llc
TR-MEXICALI SAUCE SEASONING NET WEIGHT: 50.00 LBS
Food·1,300 affected·Dec 16, 2016
High RiskFDA
Berner Food & Beverage, Llc
Our Family Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 70253266867
Food·204 affected·Dec 16, 2016
High RiskFDA
Tipiak Inc
Tipiak Pearled Couscous Easy cooking 12.3 Oz (350g) Item Number: 10020450803 Product of France
Food·27 affected·Dec 16, 2016
High RiskFDA
Fresenius Kabi Usa, Llc
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 6017...
Injectable Drugs·47 affected·Dec 16, 2016
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
Medical Implants·16 affected·Dec 16, 2016
High RiskFDA
Baxter Healthcare Corporation
APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD...
Medical Devices·8,640 affected·Dec 16, 2016
High RiskFDA
Covidien Llc
Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use wh...
Respiratory Devices·7,453 affected·Dec 16, 2016
High RiskFDA
Dicom Grid Inc
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnosti...
Diagnostic Devices·209 affected·Dec 16, 2016
High RiskFDA
Parker Medical
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL...
Respiratory Devices·1,060 affected·Dec 16, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurem...
Diagnostic Devices·11,165 affected·Dec 16, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to pr...
Diagnostic Devices·35 affected·Dec 16, 2016
High RiskFDA
Amgen, Inc.
AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufa...
Injectable Drugs·11,434 affected·Dec 15, 2016
High RiskFDA
Gentell, Inc
Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
Topical Drugs·0 affected·Dec 15, 2016
High RiskFDA
Gentell, Inc
Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentel...
Topical Drugs·3,000 affected·Dec 15, 2016
High RiskFDA
Meta Pharmacy Services
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile c...
Ophthalmic Drugs·150 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determin...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Zimmer Biomet, Inc.
Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: ...
Medical Devices·26 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique for determining t...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001...
Surgical Devices·39 affected·Dec 15, 2016
High RiskFDA
Infraredx, Inc.
TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiog...
Medical Devices·7 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining ...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determini...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique for determining the...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining ...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Great Northern Bakehouse Inc. Dba Le Petit Outre
Whole Wheat Bread, each loaf has a net wt. 32 oz.. The UPC is code 6 36428 50200 2.
Bakery & Grains·103 affected·Dec 14, 2016
High RiskFDA
Great Northern Bakehouse Inc. Dba Le Petit Outre
Birdman Bread, each loaf has net wt. 24 oz and 32 oz.. The UPC code ia 6 36428 10200 4.
Bakery & Grains·417 affected·Dec 14, 2016
High RiskFDA
Great Northern Bakehouse Inc. Dba Le Petit Outre
Italian Deli Loaf, each loaf has a net wt. 32 oz.. The UPC is code 6 36428 50200 2.
Food·72 affected·Dec 14, 2016
High RiskFDA
Great Northern Bakehouse Inc. Dba Le Petit Outre
Sourdough Deli Loaf, each loaf has a net wt. 28 oz.. The UPC is code 6 36428 50200 2
Food·165 affected·Dec 14, 2016
High RiskFDA
Great Northern Bakehouse Inc. Dba Le Petit Outre
Brewers Grain Deli Loaf, each loaf has a net wt. 24 oz.. The UPC code is 6 36428 10300 1.
Food·55 affected·Dec 14, 2016
High RiskFDA
Great Northern Bakehouse Inc. Dba Le Petit Outre
Daily Wheat Bread, each loaf has a net wt. 24 oz.. The UPC is code and 6 36428 50500 3.
Bakery & Grains·24 affected·Dec 14, 2016
High RiskFDA
Great Northern Bakehouse Inc. Dba Le Petit Outre
NY Rye Deli Loaf, each loaf has a net wt. 32 oz.. No UPC as this is for food service only.
Food·89 affected·Dec 14, 2016
High RiskFDA
Apotex Corp.
Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Ap...
Oral Drugs·13,179 affected·Dec 14, 2016
High RiskFDA
Apotex Corp.
Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: A...
Oral Drugs·35,819 affected·Dec 14, 2016