FDA Device · 2017
FDA Device recalls in 2017
RecallRadar indexes 2,615 FDA Device recall notices published in 2017. By classification: 51 Class I, 2,510 Class II, 54 Class III.
- STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,EC…
FDA Device · Class II · 2017-04-12 · Philips Electronics North America - BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging acc…
FDA Device · Class II · 2017-04-12 · Philips Medical Systems Cleveland - BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: T…
FDA Device · Class II · 2017-04-12 · Becton Dickinson And - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer
FDA Device · Class II · 2017-04-12 · Centurion Medical Products - OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer
FDA Device · Class II · 2017-04-12 · Centurion Medical Products - Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in…
FDA Device · Class II · 2017-04-12 · Siemens Healthcare Diagnostics - POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer
FDA Device · Class II · 2017-04-12 · Centurion Medical Products - Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze an…
FDA Device · Class II · 2017-04-12 · Covidien - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Syst…
FDA Device · Class II · 2017-04-12 · Beckman Coulter - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Hand Foot II, UVB-138
FDA Device · Class II · 2017-04-05 · National Biological - Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - iConnect Enterprise Archive software
FDA Device · Class II · 2017-04-05 · Merge Healthcare - Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - 7F Prelude¿ Short Sheath Introducer
FDA Device · Class I · 2017-04-05 · Merit Medical Systems - Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity…
FDA Device · Class II · 2017-04-05 · Stryker Communications - Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU)
FDA Device · Class II · 2017-04-05 · Merge Healthcare - Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with…
FDA Device · Class II · 2017-04-05 · Agfa Healthcare - Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - SynchroMed II implantable drug infusion pump, Model 8637-40
FDA Device · Class II · 2017-04-05 · Medtronic Neuromodulation - Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including…
FDA Device · Class II · 2017-04-05 · Strata Skin Sciences - Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communi…
FDA Device · Class II · 2017-04-05 · Siemens Medical Solutions Usa - Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral c…
FDA Device · Class II · 2017-04-05 · United Orthopedic - Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), fo…
FDA Device · Class II · 2017-04-05 · Siemens Healthcare Diagnostics - Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AV…
FDA Device · Class II · 2017-04-05 · Respironics California - Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Plum 360 Infusion Pump, Software Version 15.02
FDA Device · Class II · 2017-04-05 · Hospira A Pfizer - Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - JResultNet drivers using ASTM coding language
FDA Device · Class II · 2017-04-05 · Data Innovations - HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536…
FDA Device · Class I · 2017-04-05 · Philips North America - Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - 8500M Handheld Pulse Oximeter
FDA Device · Class II · 2017-04-05 · Nonin Medical - Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box
FDA Device · Class II · 2017-04-05 · Biomet 3i
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)