FDA Device · 2015
FDA Device recalls in 2015
RecallRadar indexes 2,495 FDA Device recall notices published in 2015. By classification: 77 Class I, 2,300 Class II, 118 Class III.
- The HomeChoice Pro APD System is a peritoneal dialysis system
FDA Device · Class II · 2015-03-25 · Baxter Healthcare - LeMaitre Vascular Tumescent Catheter Inversion (TCI) System
FDA Device · Class III · 2015-03-25 · Lemaitre Vascular - LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber an…
FDA Device · Class II · 2015-03-25 · Ossur H F - Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to m…
FDA Device · Class II · 2015-03-25 · Transonic Systems - E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the followi…
FDA Device · Class II · 2015-03-25 · Siemens Medical Solutions Usa - BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syrin…
FDA Device · Class II · 2015-03-25 · Bard Access Systems - Pressure IQ Evolve Mattress
FDA Device · Class II · 2015-03-18 · Arjo Hospital Equipment Ab - - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enter…
FDA Device · Class II · 2015-03-18 · Medela Ef Division - Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum…
FDA Device · Class II · 2015-03-18 · Pivotal Health Solutions - Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capill…
FDA Device · Class II · 2015-03-18 · Siemens Healthcare Diagnostics - Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
FDA Device · Class II · 2015-03-18 · Philips Medical Systems - Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection Multicap glass and Multicap-S plastic cap…
FDA Device · Class II · 2015-03-18 · Siemens Healthcare Diagnostics - EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics,…
FDA Device · Class II · 2015-03-18 · Microport Orthopedics - VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS…
FDA Device · Class II · 2015-03-18 · Ortho Clinical Diagnostics - RAPIDPoint 405 Blood Gas Analyzer
FDA Device · Class II · 2015-03-18 · Siemens Healthcare Diagnostics - RAPIDPoint 500 Blood Gas Analyzer
FDA Device · Class II · 2015-03-18 · Siemens Healthcare Diagnostics - Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800)
FDA Device · Class II · 2015-03-18 · Dako North America - Carton: Richard-Allan Scientific CYTO-STAIN
FDA Device · Class III · 2015-03-18 · Richard Allan Scientific - Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coat…
FDA Device · Class II · 2015-03-18 · Zimmer - MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K
FDA Device · Class II · 2015-03-18 · Southern Implants - Synthes Inserter for Titanium Elastic Nails
FDA Device · Class II · 2015-03-18 · Synthes - RAPIDLab 1245 System
FDA Device · Class II · 2015-03-18 · Siemens Healthcare Diagnostics - SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0
FDA Device · Class II · 2015-03-18 · Siemens Medical Solutions Usa - GE Healthcare Proteus XR/a with wall stand model number 2260354
FDA Device · Class II · 2015-03-18 · Ge Healthcare - RAPIDLab 1265 System
FDA Device · Class II · 2015-03-18 · Siemens Healthcare Diagnostics - Juno DFR X-ray system
FDA Device · Class II · 2015-03-18 · Villa Radiology Systems - Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
FDA Device · Class II · 2015-03-18 · Arrow International - Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capil…
FDA Device · Class II · 2015-03-18 · Siemens Healthcare Diagnostics - Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps
FDA Device · Class II · 2015-03-11 · Baxter Englewood - Rotoprone Therapy System
FDA Device · Class II · 2015-03-11 · Arjo Hospital Equipment Ab - ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic bal…
FDA Device · Class II · 2015-03-11 · Arrow International - SMARTSET GHV Gentamicin Bone Cement
FDA Device · Class II · 2015-03-11 · Depuy Orthopaedics - Zip 16 Surgical Skin Closure Device
FDA Device · Class II · 2015-03-11 · Zipline Medical - Zip 8M Wound Closure Device
FDA Device · Class II · 2015-03-11 · Zipline Medical - ADVIA Centaur Systems Progesterone Kit, (5 -pack)
FDA Device · Class II · 2015-03-11 · Siemens Healthcare Diagnostics - LFT v40 Femoral Head
FDA Device · Class II · 2015-03-11 · Stryker Howmedica Osteonics - KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC
FDA Device · Class II · 2015-03-11 · Halyard Health - KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC
FDA Device · Class II · 2015-03-11 · Halyard Health - CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
FDA Device · Class II · 2015-03-11 · Coopersurgical - Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials
FDA Device · Class II · 2015-03-11 · Remel - Ikaria, INOmax DSIR (Delivery System), Model 10007
FDA Device · Class II · 2015-03-11 · Ino Therapeutics Dba Ikaria - LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06
FDA Device · Class II · 2015-03-11 · Biosense Webster - The I-Cart is used to store, transport, and power video equipment used in medical procedures
FDA Device · Class II · 2015-03-11 · Richard Wolf Medical Instruments - Focal Sim radiation therapy treatment planning system
FDA Device · Class II · 2015-03-11 · Elekta - TriaDyne Proventa Critical Care Therapy System
FDA Device · Class II · 2015-03-11 · Arjo Hospital Equipment Ab - CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider managemen…
FDA Device · Class III · 2015-03-11 · Medtronic Minimed - KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC
FDA Device · Class II · 2015-03-11 · Halyard Health - Monaco radiation therapy treatment planning system
FDA Device · Class II · 2015-03-11 · Elekta - RotoRest Delta Advanced Therapy System
FDA Device · Class II · 2015-03-11 · Arjo Hospital Equipment Ab - IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number:…
FDA Device · Class I · 2015-03-11 · Boston Scientific - Xoran MiniCAT X-ray imaging device
FDA Device · Class II · 2015-03-11 · Xoran Technologies - Servo-I ventilator system CO2 analyzer
FDA Device · Class II · 2015-03-11 · Maquet Cardiovascular Us Sales - AMIA v1.0 APD System
FDA Device · Class II · 2015-03-11 · Baxter Healthcare - Zip 8i Surgical Skin Closure Device
FDA Device · Class II · 2015-03-11 · Zipline Medical - ADVIA Centaur Systems Progesterone Kit, (5-pack Ref)
FDA Device · Class II · 2015-03-11 · Siemens Healthcare Diagnostics - DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
FDA Device · Class II · 2015-03-11 · Icad - Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ceme…
FDA Device · Class II · 2015-03-11 · Zimmer - Philips Medical System Allura Xper X-Ray Angiographic
FDA Device · Class II · 2015-03-11 · Philips Medical Systems - ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic
FDA Device · Class II · 2015-03-11 · Siemens Healthcare Diagnostics - Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000)
FDA Device · Class II · 2015-03-11 · Intuitive Surgical - TDX Electric Wheelchair
FDA Device · Class II · 2015-03-04 · Invacare - Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur…
FDA Device · Class II · 2015-03-04 · Zimmer - The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervou…
FDA Device · Class II · 2015-03-04 · Medtronic Neuromodulation - The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments
FDA Device · Class I · 2015-03-04 · Hospira - NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111, STERILE, Rx ONLY For single use only. ---Device Listi…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments
FDA Device · Class I · 2015-03-04 · Hospira - Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint dise…
FDA Device · Class II · 2015-03-04 · Zimmer - NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 60101491, STERILE, Rx ONLY --- For single use only. --- Device Lis…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer…
FDA Device · Class II · 2015-03-04 · Intuitive Surgical - NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 60150692, STERILE, Rx ONLY --- For single use only. --- Device Lis…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D13…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706, STERILE, Rx ONLY --- For single use only. --- Device Li…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in…
FDA Device · Class II · 2015-03-04 · Zimmer - NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602000571, REF/Catalog No. 60200057, STERILE, Rx ONLY --- For single use only. --- Device Li…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - Set Screw 5.5 mm Rod - Model #7703-1600
FDA Device · Class II · 2015-03-04 · Biomet Spine - NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D13…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185252, STERILE, Rx ONLY --- For single use only. --- Device List…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments
FDA Device · Class I · 2015-03-04 · Hospira - NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D13…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments
FDA Device · Class I · 2015-03-04 · Hospira - NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D13…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, 5 VALVE MANIFOLD KIT, UPN H749600105121, REF/Catalog No. 60010512, STERILE, Rx ONLY --- For single use only
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device Lis…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, STERILE, Rx ONLY --- For single use only. --- Device…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000
FDA Device · Class II · 2015-03-04 · Intuitive Surgical - NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 600207212, STERILE, Rx ONLY --- For single use only. ---Device L…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for reha…
FDA Device · Class II · 2015-03-04 · Zimmer - Storm Series Electric Wheelchair
FDA Device · Class II · 2015-03-04 · Invacare - NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device Li…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 60101773, STERILE, Rx ONLY ---For single use only. --- Device Lis…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 60012591, STERILE, Rx ONLY ---For single use only. --- Device Lis…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --- For single use only. --- Device Listi…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H749600403131, REF/Catalog No. 60040313, STERILE, Rx ONLY --- --- For…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, STERILE, Rx ONLY --- For single use only. --- Device…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No. PK0604436S, STERILE, Rx ONLY - For…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - The Brainlab Offset Cup Impactor Universal
FDA Device · Class II · 2015-03-04 · Brainlab Ag - NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 60220746, STERILE, Rx ONLY ---For single use only. --- Device Lis…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H749600203741, REF/Catalog No. 60020374, STERILE, Rx ONLY --- For single use only
FDA Device · Class II · 2015-03-04 · Navilyst Medical - FDX Electric Wheelchair
FDA Device · Class II · 2015-03-04 · Invacare
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