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.
- NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - Manual Toothbrush
FDA Device · Class II · 2015-03-04 · Norwex Usa - NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713, STERILE, Rx ONLY --- For single use only. --- Device…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem compon…
FDA Device · Class II · 2015-03-04 · Zimmer - Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
FDA Device · Class II · 2015-03-04 · Biomet - NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D13…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D13…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, 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, UPN H7496006044121, REF/Catalog No. 600604412, STERILE, Rx ONLY ---For single use only. --- Device Listi…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D13…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909
FDA Device · Class II · 2015-03-04 · Angiodynamics - NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935, STERILE, Rx ONLY --- For single use only. --- Device Li…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, STERILE, Rx ONLY ---For single use only. ---Dev…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who ar…
FDA Device · Class I · 2015-03-04 · Heartware - NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600416321, REF/Catalog No. 60041632, STERILE, Rx ONLY --- For single use only. --- Device Li…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare p…
FDA Device · Class II · 2015-03-04 · Ge Healthcare - NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE, Rx ONLY --- For single use only. --- Device Listing…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 60150672, STERILE, Rx ONLY ---For single use only. --- Device Lis…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H749601801561, REF/Catalog No. 60180156, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600207211, STERILE, Rx ONLY --- For single use only
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, 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, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No. 60183662, STERILE, Rx ONLY ---- For single use only. --- Devi…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - Philips Multi Diagnost Eleva II
FDA Device · Class II · 2015-03-04 · Philips Medical Systems - Spacelabs Healthcare qube Compact Monitor, Model 91390
FDA Device · Class II · 2015-03-04 · Spacelabs Healthcare - Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
FDA Device · Class II · 2015-03-04 · Maquet Datascope Cardiac Assist Division - NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, STERILE, Rx ONLY --- For single use only. --- De…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60020236, STERILE, Rx ONLY --- For single use only
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 60160535, 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 H749601900431, REF/Catalog No. 60190043, STERILE, Rx ONLY ---For single use only. --- Device Lis…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D13…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393
FDA Device · Class II · 2015-03-04 · Spacelabs Healthcare - NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog No. 60041161, STERILE, Rx ONLY --- For single use only. --- Dev…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
FDA Device · Class II · 2015-03-04 · Iba Dosimetry - NAMIC Convenience Kit, UPN H965PK193168S1, REF/Catalog No. PK193168S, STERILE, Rx ONLY ---For single use only
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, MOBILE CATH LAB KIT, UPN H749600419211, REF/Catalog No. 60041921, STERILE, Rx ONLY --- For single use only. --- Devi…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60101162, STERILE, Rx ONLY ---For single use only. --- Device Li…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H749601827221, REF/Catalog No. 60182722, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D13…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - Philips Multi Diagnost Eleva with FlatDetector
FDA Device · Class II · 2015-03-04 · Philips Medical Systems - NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, 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 H749601113111, REF/Catalog No. 60111311, STERILE, Rx ONLY --- For single use only. --- Device Li…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. ---…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 60232234, STERILE, Rx ONLY --- For single use only. --- Device Li…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE, Rx ONLY --- For single use only. --- Device Listin…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D13…
FDA Device · Class II · 2015-03-04 · Navilyst Medical - BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
FDA Device · Class II · 2015-02-25 · Cme America - HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000
FDA Device · Class II · 2015-02-25 · Intuitive Surgical - R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated…
FDA Device · Class II · 2015-02-25 · Teleflex - HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200
FDA Device · Class II · 2015-02-25 · Intuitive Surgical - This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa H…
FDA Device · Class I · 2015-02-25 · Ge Healthcare - Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002
FDA Device · Class II · 2015-02-25 · Haemonetics - Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperat…
FDA Device · Class II · 2015-02-25 · Terumo Cardiovascular Systems - Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
FDA Device · Class II · 2015-02-25 · Biomet - Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor
FDA Device · Class III · 2015-02-25 · Alivecor Sfo - Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component
FDA Device · Class II · 2015-02-25 · Biomet - Cold Therapy Pad - cold water circulating pad, one unit per package
FDA Device · Class II · 2015-02-25 · Cincinnati Sub Zero Products - Restoris Partial Knee Application (PKA) RIO (TGS 2.0)
FDA Device · Class II · 2015-02-25 · Mako Surgical - Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body
FDA Device · Class I · 2015-02-25 · Alltech Medical Systems America - MC-500 Multicolor Laser Photocoagulator
FDA Device · Class II · 2015-02-25 · Nidek - Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package
FDA Device · Class II · 2015-02-25 · Pulsion Medical - Artis One
FDA Device · Class II · 2015-02-25 · Siemens Medical Solutions Usa - AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or ster…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump
FDA Device · Class II · 2015-02-18 · Maquet Datascope Cardiac Assist Division - EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axona…
FDA Device · Class II · 2015-02-18 · Natus Medical - ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - GemLock Long Hex Driver, Catalog RHL2.5
FDA Device · Class II · 2015-02-18 · Zimmer Dental - MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm
FDA Device · Class II · 2015-02-18 · Stryker Craniomaxillofacial Division - Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients
FDA Device · Class II · 2015-02-18 · Virtual Imaging - AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile s…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during ro…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package
FDA Device · Class II · 2015-02-18 · Integra Lifesciences - Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet
FDA Device · Class III · 2015-02-18 · Stryker Instruments Div - Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical
FDA Device · Class II · 2015-02-18 · Teleflex Medical - AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water o…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component
FDA Device · Class II · 2015-02-18 · Arthrosurface - AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water o…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit
FDA Device · Class II · 2015-02-18 · Arrow International - MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weigh…
FDA Device · Class II · 2015-02-18 · Stryker Craniomaxillofacial Division - Athrosurface 40mm 13.75x31mm Taper Post Fixation Component
FDA Device · Class II · 2015-02-18 · Arthrosurface - MAQUET Servo Humidifier 163
FDA Device · Class I · 2015-02-18 · Teleflex - Aquarius iNtuition Client Viewer
FDA Device · Class II · 2015-02-18 · Terarecon - Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licen…
FDA Device · Class II · 2015-02-18 · Elekta - Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component
FDA Device · Class II · 2015-02-18 · Arthrosurface - Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component
FDA Device · Class II · 2015-02-18 · Arthrosurface - SoftPath Laboratory Information System
FDA Device · Class II · 2015-02-18 · Scc Soft Computer - The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and…
FDA Device · Class II · 2015-02-18 · Siemens Medical Solutions Usa - AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water o…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG)…
FDA Device · Class II · 2015-02-18 · Natus Medical - AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water o…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component
FDA Device · Class II · 2015-02-18 · Arthrosurface - System 6 Aseptic Housing
FDA Device · Class II · 2015-02-18 · Stryker Instruments Div - Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 Product Usage: The Humidifier Adaptor is an ac…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water o…
FDA Device · Class II · 2015-02-18 · Teleflex Medical
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)