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High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CS...
Cardiac Devices·1,586 affected·Dec 5, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Medical Devices·47 affected·Dec 5, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasoni...
Surgical Devices·17,253 affected·Dec 5, 2013
High RiskFDA
Philips Medical Systems, Inc.
Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray syste...
Medical Devices·424 affected·Dec 5, 2013
High RiskFDA
Sorin Group Deutschland Gmbh
S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for pro...
Cardiac Devices·323 affected·Dec 4, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT ...
Diagnostic Devices·386 affected·Dec 4, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
Medical Devices·255 affected·Dec 4, 2013
High RiskFDA
The Anspach Effort, Inc.
Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cuttin...
Medical Devices·150 affected·Dec 3, 2013
High RiskFDA
Medx Holdings, Inc.
Cervical Extension Machine for Physical Therapy
Medical Devices·4 affected·Dec 3, 2013
High RiskFDA
Eos Imaging
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstati...
Medical Devices·36 affected·Nov 29, 2013
High RiskFDA
Coca Cola Bottling Company United-east, Llc
Diet Coke, 2L, 67.6 FL OZ (2 QT 3.6 FL OZ), UPC 4900005011
Food·398 affected·Nov 27, 2013
High RiskFDA
Josephson's Smokehouse
Hot Smoked Garlic Pepper Atlantic Salmon, Item HS-D, vacuum packaged and either frozen or refrigerated, ranging in size between about one...
Seafood·19 affected·Nov 27, 2013
High RiskFDA
Josephson's Smokehouse
Hot Smoked Wine Maple Salmon, Item HS-B, vacuum packaged and either frozen or refrigerated, ranging in size between about one pound to ei...
Seafood·126 affected·Nov 27, 2013
High RiskFDA
Josephson's Smokehouse
Hot Smoked Pepper Atlantic Salmon, Item HS-C, vacuum packaged and either frozen or refrigerated, ranging in size between about one poun...
Seafood·5 affected·Nov 27, 2013
High RiskFDA
B. Braun Medical Inc
0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264...
Injectable Drugs·19,572 affected·Nov 27, 2013
High RiskFDA
Wockhardt Usa Inc.
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India....
Oral Drugs·1,129 affected·Nov 27, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
Medical Devices·178,711 affected·Nov 27, 2013
High RiskFDA
Kettle Cuisine, Inc.
Phillips Food Service Lobster Bisque, 4 lb cryobag, frozen Item #45036
Seafood·3,299 affected·Nov 26, 2013
High RiskFDA
Humco Holding Group, Inc
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and inse...
Drugs·0 affected·Nov 26, 2013
High RiskFDA
Teva Pharmaceuticals Usa
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093...
Oral Drugs·10,512 affected·Nov 26, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the ST...
Medical Devices·4,048 affected·Nov 26, 2013
High RiskFDA
Becton Dickinson & Company
BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ inje...
Medical Devices·268,500 affected·Nov 26, 2013
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is desig...
Medical Devices·108,769 affected·Nov 26, 2013
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subar...
Medical Devices·731 affected·Nov 26, 2013
High RiskFDA
Stryker Medical Division Of Stryker Corporation
S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for...
Medical Devices·108,769 affected·Nov 26, 2013
High RiskFDA
Biomet, Inc.
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Medical Devices·532 affected·Nov 26, 2013
High RiskFDA
Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quanti...
Diagnostic Devices·1 affected·Nov 26, 2013
High RiskFDA
Perrigo Of Sc
EstroPlus Maximum Strength Menopause Support Dietary Supplement in 28 count and 56 count blister strips under the following labels - Care...
Baby Food & Formula·68,534 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which i...
Medical Devices·300 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or...
Medical Devices·13 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined tar...
Medical Devices·1,309 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
Medical Devices·455 affected·Nov 25, 2013
High RiskFDA
Navilyst Medical, Inc.
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; ...
Medical Implants·920 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has be...
Medical Devices·1,424 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for th...
Medical Devices·489 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determine...
Medical Devices·312 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which i...
Medical Devices·134 affected·Nov 25, 2013
High RiskFDA
Abbott Vascular, Inc.
HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 19...
Medical Devices·54,895 affected·Nov 25, 2013
High RiskFDA
Carestream Health, Inc.
DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator consol...
Diagnostic Devices·493 affected·Nov 25, 2013
High RiskFDA
Smith & Nephew Inc
REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, In...
Medical Devices·38 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very fre...
Medical Devices·1,028 affected·Nov 25, 2013
High RiskFDA
Abbott Molecular
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
Medical Devices·176 affected·Nov 23, 2013
High RiskFDA
Senor Murphy Candymaker, Llc
Senor Murphy Santa Fe Candymaker Peanut Brittle , 4 oz and 1 lb.
Snacks & Candy·339 affected·Nov 22, 2013
High RiskFDA
Senor Murphy Candymaker, Llc
Senor Murphy Santa Fe Candymaker Pinon Brittle , 4 oz and 1 lb. Handmade with pinones (pine nuts), sugar, corn syrup, butter, soda, and s...
Dairy·317 affected·Nov 22, 2013
High RiskFDA
Senor Murphy Candymaker, Llc
Senor Murphy Santa Fe Candymaker Pecan Bueno, 4oz and 1 lb. Handmade with pecans, sugar, corn syrup, butter, soda, and salt.
Dairy·116 affected·Nov 22, 2013
High RiskFDA
Senor Murphy Candymaker, Llc
Senor Murphy Santa Fe Candymaker Cashew Crunch , 4oz and 1 lb. Handmade with cashews, sugar, corn syrup, butter, soda, and salt.
Dairy·102 affected·Nov 22, 2013
High RiskFDA
Threshold Enterprises Ltd
Source Naturals Essential Enzyme Ultra VEGI-CAP: Premium Digestive Enzyme Blend; 30, 60, 90 & 120 count bottles. Vegetarian capsules ...
Food·12,352 affected·Nov 22, 2013
High RiskFDA
Senor Murphy Candymaker, Llc
Senor Murphy Santa Fe Candymaker Chile Pistachio Bark , 2.5 oz and 1 lb. Handmade with dark chocolate (sugar, chocolate liquor processe...
Dairy·670 affected·Nov 22, 2013