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.
- regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing cover light handle soft, RX. The responsible firm on…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm o…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm o…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the l…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - Zimmer Universal Locking System, Titanium 3.5mm
FDA Device · Class II · 2015-10-14 · Zimmer - regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible f…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm on t…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the l…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing cover light handle soft, RX. The responsible firm on th…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800546, Sterile, GS0635 - Abdominal - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800531, Sterile, NU0615 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the l…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible fi…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk - surgical kit containing cover light handle soft, RX. The responsible fir…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical kit containing cover light handle soft, RX. The responsible firm…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - SOMATOM Definition Edge
FDA Device · Class II · 2015-10-14 · Siemens Medical Solutions Usa - regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light handle soft, RX. The responsible firm on the labe…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on t…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit containing cover light handle soft, RX. The responsible firm…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible fir…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800557, Sterile, LD0646 - C-Section - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible fir…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible fir…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on t…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image revie…
FDA Device · Class II · 2015-10-14 · Siemens Medical Solutions Usa - SOMATOM Definition Flash
FDA Device · Class II · 2015-10-14 · Siemens Medical Solutions Usa - CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
FDA Device · Class III · 2015-10-14 · Coopersurgical - regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible fir…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Esse…
FDA Device · Class II · 2015-10-14 · Ortho Solutions - regard Item Number: 800597, Sterile, GY0688 - LAVH - surgical kit containing cover light handle soft, RX. The responsible firm on the label…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on t…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the…
FDA Device · Class II · 2015-10-14 · Resource Optimization And Innovation - Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
FDA Device · Class II · 2015-10-14 · Synthes Usa Products - P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS
FDA Device · Class II · 2015-10-07 · Medtronic Navigation - Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Re…
FDA Device · Class II · 2015-10-07 · Sterilmed - PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper
FDA Device · Class I · 2015-10-07 · Microport Orthopedics - Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: Stretcher for pre-hospital patient transport
FDA Device · Class II · 2015-10-07 · Ferno Washington - ASP-1020 LipoTower with Aspiration Pump
FDA Device · Class II · 2015-10-07 · Microaire Surgical Instruments - Zimmer Guide Wires for orthopedic procedures
FDA Device · Class II · 2015-10-07 · Zimmer - Carto 3 EP Navigation System
FDA Device · Class II · 2015-10-07 · Biosense Webster - Histolock Resection Device, US Endoscopy
FDA Device · Class II · 2015-10-07 · Us Endoscopy Group - Philips GoSafe Mobile Help Button
FDA Device · Class II · 2015-10-07 · Lifeline Systems - EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180
FDA Device · Class II · 2015-10-07 · Olympus - ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump
FDA Device · Class II · 2015-10-07 · Microaire Surgical Instruments - P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST
FDA Device · Class II · 2015-10-07 · Medtronic Navigation - SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters
FDA Device · Class II · 2015-10-07 · Biosense Webster - Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
FDA Device · Class II · 2015-10-07 · Arrow International - Fujinon/Fujifilm Processor EPX 2500 Operation Manual
FDA Device · Class II · 2015-09-30 · Fujifilm Medical Systems U - Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and…
FDA Device · Class II · 2015-09-30 · Terumo Cardiovascular Systems - Regard Custom Surgical Pack, Item Number: 800208002
FDA Device · Class II · 2015-09-30 · Resource Optimization And Innovation - Lightspeed 16 CT
FDA Device · Class II · 2015-09-30 · Ge Healthcare - Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
FDA Device · Class II · 2015-09-30 · Bien Air Dental - Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cra…
FDA Device · Class II · 2015-09-30 · Synthes Usa Products - Fujifilm Processor EPX 2500 High Definition Endoscopy
FDA Device · Class II · 2015-09-30 · Fujifilm Medical Systems U - Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed…
FDA Device · Class II · 2015-09-30 · Siemens Healthcare Diagnostics - Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to…
FDA Device · Class II · 2015-09-30 · Terumo Cardiovascular Systems - Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufa…
FDA Device · Class II · 2015-09-30 · Terumo Cardiovascular Systems - Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and…
FDA Device · Class II · 2015-09-30 · Terumo Cardiovascular Systems - The Leica ASP6025 Tissue Processor
FDA Device · Class II · 2015-09-30 · Leica Microsystems - Microtek Medical, Inc
FDA Device · Class II · 2015-09-30 · Ecolab - ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist
FDA Device · Class II · 2015-09-30 · Siemens Medical Solutions Usa - PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-…
FDA Device · Class II · 2015-09-30 · Zien Medical Technologies - CD4 (SK3), FITC
FDA Device · Class III · 2015-09-30 · Becton Dickinson And Bd Biosciences - Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting…
FDA Device · Class II · 2015-09-30 · Brainlab Ag - Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
FDA Device · Class II · 2015-09-30 · Stryker Howmedica Osteonics - PET Discovery LS
FDA Device · Class II · 2015-09-30 · Ge Healthcare - Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm
FDA Device · Class II · 2015-09-30 · Synthes Usa Products - Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed…
FDA Device · Class II · 2015-09-30 · Siemens Healthcare Diagnostics - Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured an…
FDA Device · Class II · 2015-09-30 · Terumo Cardiovascular Systems - ThruPort Knot Pusher
FDA Device · Class II · 2015-09-30 · Edwards Lifesciences - Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured an…
FDA Device · Class II · 2015-09-30 · Terumo Cardiovascular Systems - Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
FDA Device · Class II · 2015-09-30 · Bard Access Systems - Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usage: The RAPIDPoint 500 system is designed…
FDA Device · Class II · 2015-09-30 · Siemens Healthcare Diagnostics - 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw
FDA Device · Class II · 2015-09-30 · Orthopediatrics - Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed…
FDA Device · Class II · 2015-09-30 · Siemens Healthcare Diagnostics - Regard Custom Surgical Pack, Item Number: 800628
FDA Device · Class II · 2015-09-30 · Resource Optimization And Innovation - Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customiz…
FDA Device · Class II · 2015-09-30 · Terumo Cardiovascular Systems - MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150
FDA Device · Class II · 2015-09-30 · Beckman Coulter - EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, li…
FDA Device · Class II · 2015-09-30 · Olympus America - PET Discovery ST 16
FDA Device · Class II · 2015-09-30 · Ge Healthcare - Merlin@home RF Remote Monitoring Transmitter Model EX1150
FDA Device · Class II · 2015-09-23 · St Jude Medical Cardiac Rhythm Management Division - Fujifilm Medical Endoscope for the duodenum and upper G.I. tract
FDA Device · Class II · 2015-09-23 · Fujifilm Medical Systems U - Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and…
FDA Device · Class III · 2015-09-23 · Pointe Scientific - Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiat…
FDA Device · Class II · 2015-09-23 · Raysearch Laboratories Ab - Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle
FDA Device · Class III · 2015-09-23 · Pointe Scientific - Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures
FDA Device · Class II · 2015-09-23 · Medtronic Cardiac Rhythm Disease Management - ACUSON SC2000 Ultrasound System with software versions VB10B and lower
FDA Device · Class II · 2015-09-23 · Siemens Medical Solutions Usa - Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer
FDA Device · Class II · 2015-09-23 · Edward Lifesciences - Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use a…
FDA Device · Class II · 2015-09-23 · Medivators - Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct…
FDA Device · Class II · 2015-09-23 · Lumenis - Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU…
FDA Device · Class II · 2015-09-23 · Boston Scientific - NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984
FDA Device · Class II · 2015-09-23 · Salter Labs - CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning
FDA Device · Class II · 2015-09-23 · Med Tec - Angiographic Injector
FDA Device · Class II · 2015-09-23 · Bayer Healthcare - Aliquot Delivery Kit (Syringe and Plunger)
FDA Device · Class II · 2015-09-23 · Orthovita
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)