FDA Device · 2016
FDA Device recalls in 2016
RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.
- Zenostar MT Color A2 60ml, art. no. 681051
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Zenostar MT Color C1 60ml, art. no. 681059
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Zyno Medical Administration Set, Sterile
FDA Device · Class II · 2016-10-05 · Zyno Medical - Light Adaptor for Small Battery Drive and Small Battery Drive II
FDA Device · Class I · 2016-10-05 · The Anspach Effort - AQUIOS CL Flow Cytometer, Catalog No. B30166
FDA Device · Class II · 2016-10-05 · Beckman Coulter - Syngo.plaza VB10A, Picture Archiving and Communication System
FDA Device · Class II · 2016-10-05 · Siemens Medical Solutions Usa - DRI Salicylate Serum Tox Assay, Catalog number 0977
FDA Device · Class II · 2016-10-05 · Microgenics - TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters
FDA Device · Class II · 2016-10-05 · Trividia Health - Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing…
FDA Device · Class II · 2016-10-05 · Siemens Medical Solutions Usa - Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Ce…
FDA Device · Class II · 2016-10-05 · Spacelabs Healthcare - PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatm…
FDA Device · Class II · 2016-10-05 · Siemens Medical Solutions Usa - Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System
FDA Device · Class II · 2016-10-05 · Carefusion 303 - Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280
FDA Device · Class II · 2016-10-05 · Spacelabs Healthcare - Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery D…
FDA Device · Class I · 2016-10-05 · The Anspach Effort - Syngo.plaza, Picture Archiving and Communication System
FDA Device · Class II · 2016-10-05 · Siemens Medical Solutions Usa - ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
FDA Device · Class II · 2016-10-05 · Ethicon - TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters
FDA Device · Class II · 2016-10-05 · Trividia Health - Zyno Medical Administration Set, Sterile
FDA Device · Class II · 2016-10-05 · Zyno Medical - TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters
FDA Device · Class II · 2016-10-05 · Trividia Health - BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for u…
FDA Device · Class II · 2016-10-05 · Prismatik Dentalcraft - R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations…
FDA Device · Class II · 2016-10-05 · R And D Systems - CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro soft…
FDA Device · Class II · 2016-10-05 · Medtronic - Zyno Medical Administration Set, Sterile
FDA Device · Class II · 2016-10-05 · Zyno Medical - TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters
FDA Device · Class II · 2016-10-05 · Trividia Health - The EKOS cart has the catalog number 700-60101
FDA Device · Class II · 2016-10-05 · Ekos - Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracr…
FDA Device · Class II · 2016-10-05 · Spiegelberg And Kg - ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver…
FDA Device · Class II · 2016-10-05 · Siemens Medical Solutions Usa - Zyno Medical Administration Set Sterile
FDA Device · Class II · 2016-10-05 · Zyno Medical - Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglob…
FDA Device · Class II · 2016-10-05 · Siemens Healthcare Diagnostics - RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patie…
FDA Device · Class II · 2016-09-28 · Smith And Nephew - EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
FDA Device · Class II · 2016-09-28 · Ekos - St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is inten…
FDA Device · Class II · 2016-09-28 · Sorin Group Usa - Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezin…
FDA Device · Class III · 2016-09-28 · Coopersurgical - TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The product is indicated for implantation for…
FDA Device · Class II · 2016-09-28 · Abbott Medical Optics Amo - G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M
FDA Device · Class II · 2016-09-28 · The Anspach Effort - FPS 35mm x 3.5 mm non-locking screw
FDA Device · Class II · 2016-09-28 · Ortho Solutions - TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aph…
FDA Device · Class II · 2016-09-28 · Abbott Medical Optics Amo - Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
FDA Device · Class II · 2016-09-28 · Carefusion 2200 - G1 Dissection Tool - 3mm FLUTED BALL
FDA Device · Class II · 2016-09-28 · The Anspach Effort - TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual…
FDA Device · Class II · 2016-09-28 · Abbott Medical Optics Amo - Sertera Biopsy Device, Sterile
FDA Device · Class II · 2016-09-28 · Hologic - HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
FDA Device · Class II · 2016-09-28 · Philips Electronics North America - Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monito…
FDA Device · Class II · 2016-09-28 · Pentax - SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in who…
FDA Device · Class II · 2016-09-28 · Abbott Medical Optics Amo - TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual corre…
FDA Device · Class II · 2016-09-28 · Abbott Medical Optics Amo - TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes
FDA Device · Class II · 2016-09-28 · Trimed - Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin
FDA Device · Class II · 2016-09-28 · Ormco Sybronendo - MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific,…
FDA Device · Class II · 2016-09-28 · Global Healthcare - TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in who…
FDA Device · Class II · 2016-09-28 · Abbott Medical Optics Amo - 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only
FDA Device · Class II · 2016-09-28 · Biomet 3i - SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in…
FDA Device · Class II · 2016-09-28 · Abbott Medical Optics Amo - LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-adminis…
FDA Device · Class II · 2016-09-28 · Hospira - Merge Cardio software
FDA Device · Class II · 2016-09-28 · Merge Healthcare - G1 Dissection Tool - 7mm FBALL L
FDA Device · Class II · 2016-09-28 · The Anspach Effort - CADstream software
FDA Device · Class II · 2016-09-28 · Merge Healthcare - TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aph…
FDA Device · Class II · 2016-09-28 · Abbott Medical Optics Amo - PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379
FDA Device · Class II · 2016-09-28 · Integra Lifesciences D B A Integra Pain Management - 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage o…
FDA Device · Class II · 2016-09-28 · Orthopediatrics - 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage o…
FDA Device · Class II · 2016-09-28 · Orthopediatrics - Philips Expression Information Portal (IP5) Model 865471
FDA Device · Class II · 2016-09-28 · Invivo - IG1, IGF-I reagent, Catalog # LKGF1
FDA Device · Class II · 2016-09-28 · Siemens Healthcare Diagnostics - LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications
FDA Device · Class II · 2016-09-28 · Hospira - Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
FDA Device · Class II · 2016-09-28 · Carefusion 2200 - G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M
FDA Device · Class II · 2016-09-28 · The Anspach Effort - McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical im…
FDA Device · Class II · 2016-09-28 · Mckesson Medical Imaging Group - Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communicat…
FDA Device · Class II · 2016-09-28 · Siemens Medical Solutions Usa - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for the visual correcti…
FDA Device · Class II · 2016-09-28 · Abbott Medical Optics Amo - Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, commun…
FDA Device · Class II · 2016-09-28 · Siemens Medical Solutions Usa - Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertiliza…
FDA Device · Class III · 2016-09-28 · Coopersurgical - TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00
FDA Device · Class II · 2016-09-28 · Abbott Medical Optics Amo - Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usage: The…
FDA Device · Class II · 2016-09-21 · Icu Medical - 5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascu…
FDA Device · Class II · 2016-09-21 · Icu Medical - Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
FDA Device · Class II · 2016-09-21 · Siemens Healthcare Diagnostics - Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days
FDA Device · Class II · 2016-09-21 · Arrow International - Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodri…
FDA Device · Class II · 2016-09-21 · Icu Medical - Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex…
FDA Device · Class II · 2016-09-21 · Icu Medical - Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central veno…
FDA Device · Class II · 2016-09-21 · Arrow International - RadSuite software
FDA Device · Class II · 2016-09-21 · Merge Healthcare - The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Generati…
FDA Device · Class III · 2016-09-21 · Ortho Clinical Diagnostics - Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. 42…
FDA Device · Class II · 2016-09-21 · Icu Medical - Option-vm Urinary Catheter
FDA Device · Class II · 2016-09-21 · C R Bard - Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT…
FDA Device · Class II · 2016-09-21 · Icu Medical - AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with…
FDA Device · Class II · 2016-09-21 · Howmedica Osteonics - T2Candida¿Cartridges
FDA Device · Class II · 2016-09-21 · T2 Biosystems - Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of…
FDA Device · Class II · 2016-09-21 · Mentor Texas - VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for…
FDA Device · Class III · 2016-09-21 · Biomerieux France Chemin De L Or - Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identi…
FDA Device · Class II · 2016-09-21 · Thermo Finnigan - TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straig…
FDA Device · Class II · 2016-09-21 · Icu Medical - LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert
FDA Device · Class III · 2016-09-21 · Alere San Diego - CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of…
FDA Device · Class II · 2016-09-21 · Mentor Texas - Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an e…
FDA Device · Class II · 2016-09-21 · Icu Medical - Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84" Tubing, Disposable Transducer, 3 mL Squeeze Flush, Macr…
FDA Device · Class II · 2016-09-21 · Icu Medical - AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with…
FDA Device · Class II · 2016-09-21 · Howmedica Osteonics - Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an e…
FDA Device · Class II · 2016-09-21 · Icu Medical - Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets…
FDA Device · Class II · 2016-09-21 · Sysmex America - Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT)…
FDA Device · Class II · 2016-09-21 · Icu Medical - Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transd…
FDA Device · Class II · 2016-09-21 · Icu Medical - AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with a…
FDA Device · Class II · 2016-09-21 · Howmedica Osteonics - RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
FDA Device · Class II · 2016-09-21 · Siemens Healthcare Diagnostics
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