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High RiskFDA
Valeant Pharmaceuticals
AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00...
Drugs·1,097,846 affected·Oct 15, 2012
High RiskFDA
Invivo Corporation
Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healt...
Medical Devices·543 affected·Oct 15, 2012
High RiskFDA
Toshiba American Medical Systems Inc
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
Medical Devices·27 affected·Oct 15, 2012
High RiskFDA
Ossur Americas, Inc.
The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC L...
Medical Implants·144 affected·Oct 15, 2012
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fi...
Medical Devices·8 affected·Oct 12, 2012
High RiskFDA
Moog Medical Devices Group
Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for...
Medical Devices·92,488 affected·Oct 12, 2012
High RiskFDA
Ge Healthcare, Llc
GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare profe...
Medical Devices·210 affected·Oct 12, 2012
High RiskFDA
Paradise Tomato Kitchens Inc
Mazzio's Marinara Sauce, 6.65-lb pouch, 6 pouches per case Pouches are packed in cardboard box for shipment
Food·6,352 affected·Oct 11, 2012
High RiskFDA
Vintage Pharmaceuticals Llc Dba Qualitest Pharmaceuticals
Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0...
Oral Drugs·2,755 affected·Oct 11, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinic...
Medical Devices·317 affected·Oct 11, 2012
High RiskFDA
Nestle Professional
Nestle Coffee-Mate Coffee Creamer, Original Flavor, packaged as 3/8 fl oz single serve tubs.50 single serve tubs are packaged in a self d...
Beverages·520 affected·Oct 10, 2012
High RiskFDA
American Health Packaging
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus,...
Oral Drugs·19,060 affected·Oct 10, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Mobilette Mira, intended use as Mobile x-ray system.
Medical Devices·21 affected·Oct 10, 2012
High RiskFDA
Remel Inc
The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legione...
Medical Devices·10 affected·Oct 10, 2012
High RiskFDA
Alfa Wassermann, Inc.
Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ...
Diagnostic Devices·4,104 affected·Oct 10, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
Surgical Devices·1,315 affected·Oct 10, 2012
High RiskFDA
Whole Foods Market Group Inc.
Whole Foods Meal Shrimp Stir Fry, 16 oz plastic container, Refrigerated, Product Code 3640630222
Seafood·164 affected·Oct 9, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalo...
Diagnostic Devices·234 affected·Oct 9, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Cata...
Diagnostic Devices·2,440 affected·Oct 9, 2012
High RiskFDA
The Binding Site Group, Ltd.
Digital RID Plate Reader and Software Product Code: AD400
Medical Devices·0 affected·Oct 9, 2012
High RiskFDA
Kraft Foods, Inc.
Kraft Jalapeno String Cheese, Net Wt 12 Oz (340 g); a natural low-moisture part-skim mozzarella cheese with jalapeno peppers; 12 individu...
Dairy·2,711 affected·Oct 8, 2012
High RiskFDA
Glaxosmithkline, Llc.
Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. ...
Injectable Drugs·1,319 affected·Oct 8, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determin...
Diagnostic Devices·19,310 affected·Oct 8, 2012
High RiskFDA
Radiometer America Inc
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
Medical Devices·13,632 affected·Oct 8, 2012
High RiskFDA
New England Compounding Center
All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on ...
Drugs·0 affected·Oct 6, 2012
High RiskFDA
New England Compounding Center
All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found...
Drugs·0 affected·Oct 6, 2012
High RiskFDA
Earthborn Products, Inc.
Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), ...
Supplements·161 affected·Oct 5, 2012
High RiskFDA
Spacelabs Healthcare, Llc
The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and ...
Medical Devices·169 affected·Oct 5, 2012
High RiskFDA
Spinefrontier, Inc.
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm...
Medical Implants·11 affected·Oct 5, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR i...
Medical Devices·37 affected·Oct 5, 2012
High RiskFDA
Hospira, Inc.
Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc...
Injectable Drugs·120,350 affected·Oct 4, 2012
High RiskFDA
Ethicon Endo-surgery Inc
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
Surgical Devices·5,894,975 affected·Oct 4, 2012
High RiskFDA
Gasco Industrial
"Sazon con Culantro y Achiote" (seasoning)
Food·1,221 affected·Oct 3, 2012
High RiskFDA
Paddock Laboratories, Llc
Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,
Oral Drugs·2,267 affected·Oct 3, 2012
High RiskFDA
Kellogg Company
Kellogg's Variety and Assortment Packs containing Frosted/ Unfrosted Mini Wheats, Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, ...
Bakery & Grains·2,853 affected·Oct 2, 2012
High RiskFDA
American Licorice Co
American Vines band Natural Vines Black Soft Licorice Twists; All Natural Ingredients, 8 oz (226g), No Preservatives, Product is pro...
Food·13,796 affected·Oct 2, 2012
High RiskFDA
Kellogg Company
Kellogg's Frosted Mini Wheats , Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 96 ct case single serve,each Nt. Wt. 1 oz (28g); ...
Bakery & Grains·2,853 affected·Oct 2, 2012
High RiskFDA
Kellogg Company
Canadian Product: Kellogg's Mini Wheats, Brown Sugar Flavour Cereal, 6 ct., 10 ct, 12 ct, 16ct; 400G, 510G, 850 G, 1300 G
Bakery & Grains·0 affected·Oct 2, 2012
High RiskFDA
Kellogg Company
Kellogg's Mini Wheats, Unfrosted, Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 18 oz carton; 70 ct case single serve; Canad...
Bakery & Grains·2,853 affected·Oct 2, 2012
High RiskFDA
Ge Healthcare It
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold...
Cardiac Devices·1 affected·Oct 2, 2012
High RiskFDA
Becton Dickinson & Company
Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstr...
Medical Devices·2,786,000 affected·Oct 2, 2012
High RiskFDA
Costco Wholesale
Cold-Smoked Atlantic Salmon in vacuum packed plastic, labeled in part: "FOPPEN NORWEGIAN SMOKED SALMON SLICES INCLUDES PACKET OF HONEY MU...
Seafood·41,601 affected·Oct 1, 2012
High RiskFDA
Varian Medical Systems, Inc.
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tu...
Medical Devices·15 affected·Sep 28, 2012
High RiskFDA
Ventana Medical Systems Inc
VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCO...
Diagnostic Devices·54 affected·Sep 28, 2012
High RiskFDA
Biomet 3i, Llc
Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for...
Medical Implants·76 affected·Sep 28, 2012
High RiskFDA
Icu Medical, Inc.
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
Medical Devices·60 affected·Sep 28, 2012
High RiskFDA
Ventana Medical Systems Inc
VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCO...
Diagnostic Devices·1,735 affected·Sep 28, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW)...
Medical Devices·2,580 affected·Sep 28, 2012