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.
- On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart…
FDA Device · Class II · 2017-07-19 · Cryolife - 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotating Luer
FDA Device · Class II · 2017-07-19 · Icu Medical - The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general s…
FDA Device · Class II · 2017-07-19 · Icu - Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to…
FDA Device · Class II · 2017-07-19 · St Jude Medical - Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,H…
FDA Device · Class II · 2017-07-19 · O Two Medical Technologies - The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general s…
FDA Device · Class II · 2017-07-19 · Icu - The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general s…
FDA Device · Class II · 2017-07-19 · Icu - ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-r…
FDA Device · Class II · 2017-07-19 · Arjo - Alaris Pump Module model 8100
FDA Device · Class II · 2017-07-19 · Carefusion 303 - Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500
FDA Device · Class II · 2017-07-19 · Natus Neurology - Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to…
FDA Device · Class II · 2017-07-19 · St Jude Medical - Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the…
FDA Device · Class II · 2017-07-19 · Pentax - 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer
FDA Device · Class II · 2017-07-19 · Icu Medical - 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer
FDA Device · Class II · 2017-07-19 · Icu Medical - XARIO 200 TUS-X200 diagnostic ultrasound system
FDA Device · Class II · 2017-07-19 · Toshiba American Medical Systems - Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target si…
FDA Device · Class II · 2017-07-19 · Elekta - Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200
FDA Device · Class II · 2017-07-19 · Natus Neurology - The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general s…
FDA Device · Class II · 2017-07-19 · Icu - Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
FDA Device · Class II · 2017-07-19 · Arrow International - Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to…
FDA Device · Class II · 2017-07-19 · St Jude Medical - 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotati…
FDA Device · Class II · 2017-07-19 · Icu Medical - XARIO 100 TUS-X100 diagnostic ultrasound system
FDA Device · Class II · 2017-07-19 · Toshiba American Medical Systems - APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
FDA Device · Class II · 2017-07-19 · Toshiba American Medical Systems - Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer w…
FDA Device · Class II · 2017-07-19 · Nova Biomedical - VIDAS Testosterone, Ref 30418
FDA Device · Class II · 2017-07-19 · Biomerieux - Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripher…
FDA Device · Class II · 2017-07-19 · Fujifilm Medical Systems U - Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to…
FDA Device · Class II · 2017-07-19 · St Jude Medical - ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series
FDA Device · Class I · 2017-07-19 · Oscor - Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300
FDA Device · Class II · 2017-07-19 · Natus Neurology - APLIO 500 TUS-A500 diagnostic ultrasound system
FDA Device · Class II · 2017-07-19 · Toshiba American Medical Systems - O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Ad…
FDA Device · Class II · 2017-07-19 · O Two Medical Technologies - 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer
FDA Device · Class II · 2017-07-19 · Icu Medical - The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general s…
FDA Device · Class II · 2017-07-19 · Icu - PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer
FDA Device · Class II · 2017-07-19 · Icu Medical - APLIO 300 TUS-A300 diagnostic ultrasound system
FDA Device · Class II · 2017-07-19 · Toshiba American Medical Systems - ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series
FDA Device · Class I · 2017-07-19 · Oscor - 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer
FDA Device · Class II · 2017-07-19 · Icu Medical - Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
FDA Device · Class II · 2017-07-19 · Arrow International - The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general s…
FDA Device · Class II · 2017-07-19 · Icu - 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer
FDA Device · Class II · 2017-07-19 · Icu Medical - Proteus 235 and Proteus ONE proton therapy systems
FDA Device · Class II · 2017-07-12 · Ion Beam Applications - EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
FDA Device · Class II · 2017-07-12 · Exactech - Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
FDA Device · Class II · 2017-07-12 · Medacta Usa - Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation…
FDA Device · Class II · 2017-07-12 · Beckman Coulter - EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
FDA Device · Class II · 2017-07-12 · Exactech - Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II…
FDA Device · Class II · 2017-07-12 · Perkinelmer Life Sciences - Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in v…
FDA Device · Class II · 2017-07-12 · Mallinckrodt Manufacturing - 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from u…
FDA Device · Class II · 2017-07-12 · Encore Medical - Logic Fit Tibial Tamp Head
FDA Device · Class II · 2017-07-12 · Exactech - Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system
FDA Device · Class II · 2017-07-12 · Boston Scientific - Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number…
FDA Device · Class II · 2017-07-12 · Sterilmed - Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
FDA Device · Class II · 2017-07-12 · Boston Scientific - EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
FDA Device · Class II · 2017-07-12 · Exactech - CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitiz…
FDA Device · Class II · 2017-07-12 · Cardiotek Bv - 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from u…
FDA Device · Class II · 2017-07-12 · Encore Medical - Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system desi…
FDA Device · Class II · 2017-07-12 · Beckman Coulter - EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
FDA Device · Class II · 2017-07-12 · Exactech - Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO
FDA Device · Class II · 2017-07-12 · Smiths Medical Asd - Alaris PC Unit, Model 8015
FDA Device · Class II · 2017-07-12 · Carefusion 303 - EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
FDA Device · Class II · 2017-07-12 · Exactech - Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer
FDA Device · Class II · 2017-07-12 · Siemens Medical Solutions Usa - Nussloch GmbH ASP6025 Tissue Processor
FDA Device · Class II · 2017-07-12 · Leica Microsystems - Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent
FDA Device · Class II · 2017-07-12 · Jas Diagnostics - EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
FDA Device · Class II · 2017-07-12 · Exactech - Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliv…
FDA Device · Class II · 2017-07-12 · Ion Beam Applications - Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
FDA Device · Class II · 2017-07-12 · Boston Scientific - LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
FDA Device · Class II · 2017-07-05 · Smith And Nephew - IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document…
FDA Device · Class II · 2017-07-05 · Agfa Healthcare - TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring…
FDA Device · Class II · 2017-07-05 · Mindray Ds Usa - Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing sm…
FDA Device · Class II · 2017-07-05 · Covidien - SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro
FDA Device · Class II · 2017-07-05 · Shimadzu Medical Systems Usa Com - ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM
FDA Device · Class II · 2017-07-05 · Onkos Surgical - DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedure…
FDA Device · Class II · 2017-07-05 · Deroyal Industries - High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment i…
FDA Device · Class II · 2017-07-05 · Olympus - Merge LIS software
FDA Device · Class II · 2017-07-05 · Merge Healthcare - LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) R…
FDA Device · Class II · 2017-07-05 · Smith And Nephew - Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
FDA Device · Class II · 2017-07-05 · Beckman Coulter - The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
FDA Device · Class III · 2017-07-05 · Medtest Holdings - ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM
FDA Device · Class II · 2017-07-05 · Onkos Surgical - Access System-Free T4 Assay, B01902E, Catalog No. 33880
FDA Device · Class II · 2017-07-05 · Beckman Coulter - BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
FDA Device · Class II · 2017-07-05 · Cryolife - ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF…
FDA Device · Class II · 2017-07-05 · Onkos Surgical - Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution
FDA Device · Class III · 2017-07-05 · Medtest Holdings - Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a c…
FDA Device · Class II · 2017-07-05 · Exactech - Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records ph…
FDA Device · Class II · 2017-07-05 · Merge Healthcare - Access Total T3, A34435H, Catalog No. 33830
FDA Device · Class II · 2017-07-05 · Beckman Coulter - SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and…
FDA Device · Class II · 2017-07-05 · Merge Healthcare - DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked imm…
FDA Device · Class III · 2017-07-05 · Euro Diagnostica Ab - Access Thyroglobulin, A34085G, Catalog No. 33860
FDA Device · Class II · 2017-07-05 · Beckman Coulter - 3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure…
FDA Device · Class II · 2017-07-05 · 3m Health Care Business - da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control…
FDA Device · Class II · 2017-07-05 · Intuitive Surgical - SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images o…
FDA Device · Class II · 2017-07-05 · Shimadzu Medical Systems Usa Com - DRX-Revolution Mobile X-Ray System
FDA Device · Class II · 2017-07-05 · Carestream Health - MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage:…
FDA Device · Class II · 2017-07-05 · Merge Healthcare - Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use ca…
FDA Device · Class III · 2017-07-05 · Medtest Holdings - MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics moni…
FDA Device · Class II · 2017-07-05 · Merge Healthcare - SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined wit…
FDA Device · Class II · 2017-07-05 · Shimadzu Medical Systems Usa Com - ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Numb…
FDA Device · Class II · 2017-07-05 · Eos Imaging - MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage…
FDA Device · Class II · 2017-07-05 · Elekta - Merge OrthoPACS software
FDA Device · Class II · 2017-06-28 · Merge Healthcare
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)