FDA Device · 2014
FDA Device recalls in 2014
RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.
- Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box
FDA Device · Class II · 2014-12-03 · Remel - 8MM,LARGE NEEDLE DRIVER
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - LUNA Chest, Model No. LU4006
FDA Device · Class III · 2014-12-03 · Novadaq Technologies - 8MM FENESTRATED BIPOLAR FORCEPS
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - 8MM, DUAL BLADE RETRACTOR
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum
FDA Device · Class II · 2014-12-03 · Biomerica - Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-co…
FDA Device · Class II · 2014-12-03 · Respironics California - 8MM, LARGE HEM-O-LOK CLIP APPLIER
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - 8MM,POTTS SCISSORS
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix S…
FDA Device · Class I · 2014-12-03 · Synthes Usa Products - 8MM,MEDIUM-LARGE CLIP APPLIER
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing
FDA Device · Class II · 2014-12-03 · Abbott Molecular - Gyrus ACMI Disposable Falope-Ring Band Applicator Kits
FDA Device · Class II · 2014-12-03 · Gyrus Acmi - 8MM MONOPOLAR CURVED SCISSORS
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - 8MM,PROGRASP FORCEPS
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - AlignRT- Intended for prescription use
FDA Device · Class II · 2014-12-03 · Vision Rt - 8MM, CARDIAC PROBE GRASPER
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer…
FDA Device · Class II · 2014-12-03 · Abbott Ireland Diagnostics Division - Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the c…
FDA Device · Class II · 2014-12-03 · Market Tiers - The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radio…
FDA Device · Class II · 2014-12-03 · Summit Industries - 8MM,BLACK DIAMOND MICRO FORCEPS
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - Dharma Cavity Varnish 15mL
FDA Device · Class II · 2014-12-03 · Dharma Research - 8MM, MEGA SUTURECUT ND
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - Trabecular Metal Tibial Impactor
FDA Device · Class II · 2014-12-03 · Zimmer - Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box
FDA Device · Class II · 2014-12-03 · Remel - Trabecular Metal Tibial Impactor Replacement Pads
FDA Device · Class II · 2014-12-03 · Zimmer - 8MM,LONG TIP FORCEPS
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - 8MM, TENACULUM FORCEPS
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - Dharma Cavity Varnish with Fluoride
FDA Device · Class II · 2014-12-03 · Dharma Research - GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150
FDA Device · Class II · 2014-12-03 · Hospira - Siemens Dimension HB1C Flex reagent cartridge
FDA Device · Class II · 2014-12-03 · Siemens Healthcare Diagnostics - 8MM RESANO FORCEPS
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - Non-sterile drape
FDA Device · Class III · 2014-12-03 · Novadaq Technologies - 8MM PERMANENT CAUTERY HOOK
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - 8MM,MARYLAND BIPOLAR FORCEPS
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg
FDA Device · Class II · 2014-12-03 · Remel - 8MM,MICRO BIPOLAR FORCEPS
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis an…
FDA Device · Class II · 2014-12-03 · Coopersurgical - 8MM, TIP-UP FENESTRATED GRASPER
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity
FDA Device · Class II · 2014-12-03 · Discus Dental - ENT PRGM 9734636 ADD FUSION NAV AxiEM
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - Etest¿ Ceftaroline (CPT32) US B100
FDA Device · Class III · 2014-11-26 · Biomerieux - BIOPSY NEEDLE KIT, 9733068, PASSIVE
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - Etest¿ Ceftaroline (CPT32) WWB100
FDA Device · Class III · 2014-11-26 · Biomerieux - PACK 9731975 TUMOR RESECTION AXIEM CR
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the pr…
FDA Device · Class II · 2014-11-26 · Synthes - The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants
FDA Device · Class II · 2014-11-26 · Medacta Usa - LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case
FDA Device · Class II · 2014-11-26 · Biomet Spine - MC-500 Multicolor Laser Photocoagulator using software version 2.20
FDA Device · Class II · 2014-11-26 · Nidek - KIT, 9731427, THORACIC TACTILE PROBES
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator
FDA Device · Class II · 2014-11-26 · Accuray - DISP 9730951 STRL SPHERE, 5PK INSERT
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - TUMOR RESECTION KIT 9733607 NON-INVASIVE
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled f…
FDA Device · Class II · 2014-11-26 · Soma Access Systems - Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulatio…
FDA Device · Class II · 2014-11-26 · Siemens Medical Solutions Usa - Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20
FDA Device · Class II · 2014-11-26 · Nidek - BAG 9732315 MOUSE STERILE 15 PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - PATIENT TRACKER 9733534XOM ENT 1PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue
FDA Device · Class II · 2014-11-26 · Silver Star Brands - SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01
FDA Device · Class II · 2014-11-26 · Monteris Medical - DISP 9730950 STRL SPHERE, 1 PK INSERT
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - Etest¿ Ceftaroline (CPT32) US B30
FDA Device · Class III · 2014-11-26 · Biomerieux - Etest¿ Ceftaroline (CPT32) WW B30
FDA Device · Class III · 2014-11-26 · Biomerieux - MediChoice Dual-Release Folding Walker with 5" wheel
FDA Device · Class II · 2014-11-26 · Owens And Minor Distribution - FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01
FDA Device · Class II · 2014-11-26 · Monteris Medical - ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems)…
FDA Device · Class III · 2014-11-26 · Siemens Healthcare Diagnostics - MOUSE 9732721 STERILE O-ARM 10PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - TUMOR RES. PACK 9733553 AxiEM S.M
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - Etest¿ Ceftaroline (CPT32) US B30
FDA Device · Class III · 2014-11-26 · Biomerieux - INSTRUMENT TRACKER 9733533XOM ENT 1PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - DRAPE 9732722 TUBE STERILE O-ARM 20PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery
FDA Device · Class II · 2014-11-26 · Elekta - PIN, 9733235, 100MM, STERILE, PERC REF
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - TRAJ GUIDE KIT, 9733066, BIOPSY, INT
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - SHUNT KIT 9733605 NON-INVASIVE
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device
FDA Device · Class II · 2014-11-26 · Nidek - TUMOR RESECTION KIT 9733608 SKULL MOUNT
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - PIN, 9733236, 150MM, STERILE, PERC REF
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma u…
FDA Device · Class III · 2014-11-26 · Siemens Healthcare Diagnostics - TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - SPHERES 8801075 5/TRAY 12PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - BIT 9733516 2.9mm DRILL STERILE
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - SPHERES 8801071 1/TRAY 12PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - INST 9731132 KIT CR REF FRAME DRIVER 5PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation - Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch
FDA Device · Class II · 2014-11-26 · Edwards Lifesciences - IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ S…
FDA Device · Class III · 2014-11-19 · Siemens Healthcare Diagnostics - Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for sin…
FDA Device · Class II · 2014-11-19 · Siemens Medical Solutions Usa - Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees
FDA Device · Class II · 2014-11-19 · Integra Lifesciences - Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures inv…
FDA Device · Class II · 2014-11-19 · Davol Subs C R Bard - Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg
FDA Device · Class II · 2014-11-19 · Remel - GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II…
FDA Device · Class II · 2014-11-19 · Ge Healthcare - Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035
FDA Device · Class II · 2014-11-19 · Philips Medical Systems - Rapid Neg BP Combo Panel Type 3
FDA Device · Class I · 2014-11-19 · Siemens Healthcare Diagnostics - Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system
FDA Device · Class II · 2014-11-19 · Ge Healthcare - AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850
FDA Device · Class II · 2014-11-19 · American Medical Systems - GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement
FDA Device · Class II · 2014-11-19 · Medacta Usa - Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal byp…
FDA Device · Class II · 2014-11-19 · Maquet Cardiovascular Us Sales - GE Healthcare Varicam/VG and VG Hawkeye devices
FDA Device · Class II · 2014-11-19 · Ge Healthcare
Other years
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