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.
- Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator
FDA Device · Class II · 2017-03-29 · Ohmeda Medical - Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system
FDA Device · Class II · 2017-03-29 · Stanley Security Solutions - Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended…
FDA Device · Class II · 2017-03-29 · Siemens Medical Solutions Usa - Panta Nail, Rx only, Sterile
FDA Device · Class II · 2017-03-29 · Integra Lifesciences - Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a patent airway for a pa…
FDA Device · Class II · 2017-03-29 · Teleflex Medical - Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonat…
FDA Device · Class II · 2017-03-29 · Ohmeda Medical - Hitachi Oasis MRI System
FDA Device · Class II · 2017-03-29 · Hitachi Medical Systems America - Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI
FDA Device · Class II · 2017-03-29 · Merge Healthcare - Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly C…
FDA Device · Class II · 2017-03-29 · Medtronic Sofamor Danek Usa - Merge Cardio software
FDA Device · Class II · 2017-03-29 · Merge Healthcare - MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R
FDA Device · Class II · 2017-03-29 · Crossroads Extremity Systems - Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under…
FDA Device · Class II · 2017-03-29 · Devicor Medical Products - ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high)
FDA Device · Class II · 2017-03-29 · Biomerieux - PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia a…
FDA Device · Class II · 2017-03-29 · Purewick - Hitachi Echelon Oval MRI System
FDA Device · Class II · 2017-03-29 · Hitachi Medical Systems America - 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated fo…
FDA Device · Class II · 2017-03-29 · Medical Components - ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low)
FDA Device · Class II · 2017-03-29 · Biomerieux - Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b)…
FDA Device · Class II · 2017-03-29 · Medtronic Sofamor Danek Usa - Merge Cardio software
FDA Device · Class II · 2017-03-29 · Merge Healthcare - ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32
FDA Device · Class II · 2017-03-29 · Biomerieux - ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32
FDA Device · Class II · 2017-03-29 · Biomerieux - Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare
FDA Device · Class II · 2017-03-29 · Merge Healthcare - Mevatron M2/Primus Mid-Energy PRIMUS HI
FDA Device · Class II · 2017-03-29 · Siemens Medical Solutions Usa - ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024
FDA Device · Class II · 2017-03-29 · Biomerieux - Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer
FDA Device · Class II · 2017-03-29 · Ohmeda Medical - Final Fit Software Version 1.11 and 1.12
FDA Device · Class II · 2017-03-29 · Nidek - Giraffe Incubator The Giraffe Incubator is an infant incubator
FDA Device · Class II · 2017-03-29 · Ohmeda Medical - IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate…
FDA Device · Class II · 2017-03-29 · Ohmeda Medical - ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous…
FDA Device · Class II · 2017-03-29 · Siemens Healthcare Diagnostics - Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly…
FDA Device · Class II · 2017-03-29 · Medtronic Sofamor Danek Usa - Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E…
FDA Device · Class II · 2017-03-29 · Medtronic Vascular - ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256
FDA Device · Class II · 2017-03-29 · Biomerieux - Raindrop Near Vision Inlay, Model# RD1-1
FDA Device · Class II · 2017-03-29 · Revision Optics - AMS-636, 60" Microbore extension set
FDA Device · Class II · 2017-03-29 · Vygon Mfg Dba Churchill Medical Systems - ONCOR" Avant-garde
FDA Device · Class II · 2017-03-29 · Siemens Medical Solutions Usa - BNX Fine Need Aspiration System (19GA)
FDA Device · Class II · 2017-03-22 · Medtronic - Toshiba Kalare DREX-KL80 X-ray generator
FDA Device · Class II · 2017-03-22 · Toshiba American Medical Systems - Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard…
FDA Device · Class II · 2017-03-22 · Terumo Cardiovascular Systems - Artis Zee and Zeego fluoroscopic x-ray system
FDA Device · Class II · 2017-03-22 · Siemens Medical Solutions Usa - CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15
FDA Device · Class II · 2017-03-22 · Smiths Medical Asd - SharkCore LG Fine Needle Biopsy System (19GA)
FDA Device · Class II · 2017-03-22 · Medtronic - The ABL800 Model#:All
FDA Device · Class II · 2017-03-22 · Radiometer America - Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound en…
FDA Device · Class II · 2017-03-22 · Terumo Cardiovascular Systems - C2 CryoBalloon Ablation System - Controller Cap
FDA Device · Class II · 2017-03-22 · C2 Therapeutics - LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular - Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
FDA Device · Class II · 2017-03-22 · Corentec - SharkCore Fine Needle Biopsy System (22 GA)
FDA Device · Class II · 2017-03-22 · Medtronic - Axiom Artis fluoroscopic x-ray system
FDA Device · Class II · 2017-03-22 · Siemens Medical Solutions Usa - VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/…
FDA Device · Class II · 2017-03-22 · Ortho Clinical Diagnostics - LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular - Toshiba Ultimax DREX-ULT80 X-ray generator
FDA Device · Class II · 2017-03-22 · Toshiba American Medical Systems - OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
FDA Device · Class II · 2017-03-22 · Ge Oec Medical Systems - ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oxim…
FDA Device · Class II · 2017-03-22 · Radiometer America - .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Gu…
FDA Device · Class II · 2017-03-22 · Acumed - 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of EC…
FDA Device · Class II · 2017-03-22 · Philips Medical Systems Cleveland - Eclipse Hypodermic Needle
FDA Device · Class II · 2017-03-22 · Becton Dickinson And - Merge Hemo software
FDA Device · Class II · 2017-03-22 · Merge Healthcare - 882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies
FDA Device · Class II · 2017-03-22 · Philips Medical Systems Cleveland - LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular - LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular - RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound
FDA Device · Class II · 2017-03-22 · Rti Surgical - LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular - Artis Q and Q.Zen fluoroscopic x-ray system
FDA Device · Class II · 2017-03-22 · Siemens Medical Solutions Usa - Inion GRT Tack, drill bit and tack appl., 4x, Sterile
FDA Device · Class II · 2017-03-22 · Inion - LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular - iConnect Enterprise Archive when used with RadSuite
FDA Device · Class II · 2017-03-22 · Merge Healthcare - SharkCore Fine Needle Biopsy System (25GA)
FDA Device · Class II · 2017-03-22 · Medtronic - L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France
FDA Device · Class II · 2017-03-22 · Kiscomedica - 882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies
FDA Device · Class II · 2017-03-22 · Philips Medical Systems Cleveland - Arkon Anesthesia Delivery System, Model 99999
FDA Device · Class II · 2017-03-22 · Del Mar Reynolds Medical - Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035
FDA Device · Class II · 2017-03-22 · Smiths Medical Asd - LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular - VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction…
FDA Device · Class II · 2017-03-22 · Maquet Cardiovascular - LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular - MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a contain…
FDA Device · Class II · 2017-03-22 · Carefusion 303 - LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular - MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
FDA Device · Class II · 2017-03-22 · Carefusion 303 - LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular - LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular - LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular - BNX Fine Need Aspiration System (22GA)
FDA Device · Class II · 2017-03-22 · Medtronic - Dimension Vista LOCI Progesterone
FDA Device · Class II · 2017-03-15 · Siemens Healthcare Diagnostics - CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant
FDA Device · Class II · 2017-03-15 · Metrex Research - The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR a…
FDA Device · Class I · 2017-03-15 · Physio Control - MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear…
FDA Device · Class II · 2017-03-15 · Siemens Medical Solutions Usa - MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems…
FDA Device · Class II · 2017-03-15 · Siemens Medical Solutions Usa - DR Systems Unity PACS software, now known as Merge Unity PACS
FDA Device · Class II · 2017-03-15 · Merge Healthcare - A-series lift - A625 Manual Part No. 324117
FDA Device · Class II · 2017-03-15 · Ergosafe Products Dba Prism Medical - CELL-DYN Ruby System: List Number: 08H6701
FDA Device · Class II · 2017-03-15 · Abbott Laboratories - ADVIA Centaur Progesterone
FDA Device · Class II · 2017-03-15 · Siemens Healthcare Diagnostics - MicroAire K-Wires
FDA Device · Class II · 2017-03-15 · Microaire Surgical Instruments - Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear
FDA Device · Class II · 2017-03-15 · The See Clear - Premier Guard Drape, Sterile
FDA Device · Class II · 2017-03-15 · Covidien - IMMULITE 2000 Progesterone
FDA Device · Class II · 2017-03-15 · Siemens Healthcare Diagnostics - AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls…
FDA Device · Class II · 2017-03-15 · Boston Scientific - Juno DRF
FDA Device · Class II · 2017-03-15 · Villa Sistemi Medicali S P A - EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Produc…
FDA Device · Class II · 2017-03-15 · Becton Dickinson And - Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care…
FDA Device · Class II · 2017-03-15 · Siemens Medical Solutions Usa - Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained…
FDA Device · Class II · 2017-03-15 · Siemens Medical Solutions Usa - PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear a…
FDA Device · Class II · 2017-03-15 · Siemens Medical Solutions Usa
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)