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High RiskFDA
The Anspach Effort, Inc.
IMRI MOTOR Product Usage: Pneumatic system
Medical Devices·3 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
Foot Control, SC2100 Product Usage: Electric system
Medical Devices·320 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
22CM MICRO REVISION ATTACH, BLACK MAX
Medical Devices·25 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
Autolube-III with NK Product Usage: Pneumatic system
Medical Devices·1 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
Medical Devices·821 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system
Medical Devices·17 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
Adult Craniotome Product Usage: Pneumatic system
Medical Devices·2,878 affected·Oct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
20.2cm Heavy Duty Long Heavy Short Attachment
Medical Devices·206 affected·Oct 6, 2016
CriticalFDA
Professional Botanicals
Professional Botanicals MealPlex (756 grams) and Veo Natural Pearl 3.0 (378 grams) Ultimate Meal Drinks in Plastic Tub Containers. Dieta...
Beverages·192 affected·Oct 5, 2016
RecallFDA
Rikki Usa, Inc.
Hollandaise Sauce, sold as Sallere Classic Sauces and Butters, refrigerated product. Each plastic tub has a net wt 7 oz. The label i...
Dairy·125 affected·Oct 5, 2016
High RiskFDA
King Henry's, Inc.
Gummy Frogs, 6oz, UPC 6105465200, 61054645500
Food·470 affected·Oct 5, 2016
High RiskFDA
King Henry's, Inc.
Gummy Frogs, 2.5oz, UPC 61054635210
Food·470 affected·Oct 5, 2016
High RiskFDA
Par Pharmaceutical, Inc.
Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed ...
Ophthalmic Drugs·182,856 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of ...
Cardiac Devices·33 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introdu...
Cardiac Devices·991 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Cathete...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Cathe...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Cardiology: Boston Scientific Guider Softip XF Guide Catheters...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduc...
Cardiac Devices·55 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the ...
Cardiac Devices·110 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston Scientific Guider Softip XF Guide Catheters a...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters a...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters ar...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Intuitive Surgical, Inc.
da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical End...
Surgical Devices·677 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introd...
Cardiac Devices·1,729 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of t...
Cardiac Devices·21 affected·Oct 5, 2016
CriticalFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or olde...
Medical Devices·11,860 affected·Oct 5, 2016
CriticalFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No...
Medical Devices·3,337 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the...
Cardiac Devices·74 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the...
Cardiac Devices·70 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introdu...
Cardiac Devices·59 affected·Oct 5, 2016
High RiskFDA
Alphatec Spine, Inc.
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for pos...
Surgical Devices·16,972 affected·Oct 5, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
Diagnostic Devices·37,437 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduct...
Cardiac Devices·45 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the h...
Cardiac Devices·30 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the h...
Cardiac Devices·156 affected·Oct 5, 2016
High RiskFDA
C.r. Bard, Inc.
Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is an all silicone,...
Surgical Devices·10,290 affected·Oct 5, 2016
CriticalFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 ...
Medical Devices·10,516 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of ...
Cardiac Devices·26 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introdu...
Cardiac Devices·186 affected·Oct 5, 2016
High RiskFDA
Maquet Medical Systems Usa
Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interfa...
Surgical Devices·9 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Cath...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of...
Cardiac Devices·34 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the h...
Cardiac Devices·991 affected·Oct 5, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
Diagnostic Devices·69,781 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the...
Cardiac Devices·124 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider Softip XF Guide Catheters a...
Surgical Devices·1,478 affected·Oct 5, 2016