FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
FDA Device · Class II · 2019-07-24 · Spinefrontier - Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits
FDA Device · Class II · 2019-07-24 · Medline Industries - Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution
FDA Device · Class II · 2019-07-24 · Pharmaceutical Innovations - Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT…
FDA Device · Class I · 2019-07-24 · Teleflex Medical - Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatm…
FDA Device · Class II · 2019-07-24 · Elekta - Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC
FDA Device · Class II · 2019-07-24 · Djo - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use
FDA Device · Class I · 2019-07-24 · Datascope - Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applicati…
FDA Device · Class II · 2019-07-24 · Ge Healthcare - Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin
FDA Device · Class I · 2019-07-24 · Carefusion 303 - CS300 Intra-Aortic Balloon Pump, English, 110V
FDA Device · Class I · 2019-07-24 · Datascope - RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
FDA Device · Class III · 2019-07-24 · Teleflex Medical - Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
FDA Device · Class II · 2019-07-24 · Ge Healthcare - DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
FDA Device · Class II · 2019-07-24 · Deroyal Industries - CS100 Intra-Aortic Balloon Pump, English, 110V
FDA Device · Class I · 2019-07-24 · Datascope - Cios care fusion system
FDA Device · Class II · 2019-07-17 · Siemens Medical Solutions Usa - Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regu…
FDA Device · Class I · 2019-07-17 · Ge Healthcare - ColoCARE, Cat
FDA Device · Class II · 2019-07-17 · Helena Laboratories - Cios Alpha VA20/ VA30 mobile X-Ray systems
FDA Device · Class II · 2019-07-17 · Siemens Medical Solutions Usa - Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5,…
FDA Device · Class II · 2019-07-17 · Philips North America - ColoCARE, Cat
FDA Device · Class II · 2019-07-17 · Helena Laboratories - Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regula…
FDA Device · Class I · 2019-07-17 · Ge Healthcare - HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation o…
FDA Device · Class I · 2019-07-17 · Hamilton Medical Ag - Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x…
FDA Device · Class II · 2019-07-17 · Canon Medical System Usa - Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp
FDA Device · Class II · 2019-07-17 · Applied Medical Resources - Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary…
FDA Device · Class II · 2019-07-17 · Rinovum Women S Health - E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile
FDA Device · Class II · 2019-07-17 · Richard Wolf Medical Instruments - Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 1…
FDA Device · Class I · 2019-07-17 · Becton Dickinson And - MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 881381…
FDA Device · Class II · 2019-07-17 · Covidien - ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
FDA Device · Class II · 2019-07-10 · Bio Detek - DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate impla…
FDA Device · Class II · 2019-07-10 · Zimmer Biomet - EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheum…
FDA Device · Class II · 2019-07-10 · Phadia Ab - ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Cre…
FDA Device · Class II · 2019-07-10 · Siemens Healthcare Diagnostics - REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute ren…
FDA Device · Class II · 2019-07-10 · Baxter Healthcare - RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RaySt…
FDA Device · Class II · 2019-07-10 · Raysearch Laboratories Ab - iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial
FDA Device · Class II · 2019-07-10 · Beckman Coulter - Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillati…
FDA Device · Class II · 2019-07-10 · Zoll Medical - Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography syste…
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography syst…
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine,…
FDA Device · Class II · 2019-07-10 · Ortho Clinical Diagnostics - SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography syste…
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model…
FDA Device · Class II · 2019-07-10 · Medtronic Navigation Littleton - cobas p 701 post-analytical units, Part Number 05349966001
FDA Device · Class III · 2019-07-10 · Roche Diagnostics - Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one…
FDA Device · Class II · 2019-07-10 · Johnson And Johnson Surgical Vision - Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems
FDA Device · Class II · 2019-07-10 · Philips Medical Systems Cleveland - SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system…
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine…
FDA Device · Class II · 2019-07-10 · Ortho Clinical Diagnostics - SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography syste…
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - Powerheart¿ G5 Automatic AED
FDA Device · Class II · 2019-07-10 · Cardiac Science - Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - CLEO Patient Monitor /Tranquility VS Patient Monitor
FDA Device · Class II · 2019-07-10 · Infinium Medical - EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A
FDA Device · Class II · 2019-07-10 · Bio Rad Laboratories - Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute ren…
FDA Device · Class II · 2019-07-10 · Baxter Healthcare - Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation,…
FDA Device · Class II · 2019-07-10 · Ge Healthcare - Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z
FDA Device · Class II · 2019-07-10 · Madison Polymeric Engineering - Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatin…
FDA Device · Class II · 2019-07-10 · Siemens Healthcare Diagnostics - Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare i…
FDA Device · Class II · 2019-07-10 · Ge Healthcare - SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system…
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate impl…
FDA Device · Class II · 2019-07-10 · Zimmer Biomet - Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of o…
FDA Device · Class II · 2019-07-10 · Zimmer Biomet - VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine,…
FDA Device · Class II · 2019-07-10 · Ortho Clinical Diagnostics - cobas p 501 post-analytical units, Part Number 05158494001
FDA Device · Class III · 2019-07-10 · Roche Diagnostics - First Step Draco Pad, Product Number EP-4D
FDA Device · Class II · 2019-07-10 · Madison Polymeric Engineering - SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography syst…
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on se…
FDA Device · Class II · 2019-07-10 · Ortho Clinical Diagnostics - SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography syst…
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
FDA Device · Class II · 2019-07-10 · Siemens Medical Solutions Usa - Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10
FDA Device · Class II · 2019-07-03 · Thermo Fisher Scientific Asheville - PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system
FDA Device · Class II · 2019-07-03 · Hitachi America Power Systems Division - Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves
FDA Device · Class II · 2019-07-03 · Medtronic - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions
FDA Device · Class I · 2019-07-03 · Vyaire Medical - Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20
FDA Device · Class II · 2019-07-03 · Thermo Fisher Scientific Asheville - Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral…
FDA Device · Class II · 2019-07-03 · Medtronic - Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
FDA Device · Class II · 2019-07-03 · Ethicon Endo Surgery - Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral…
FDA Device · Class II · 2019-07-03 · Medtronic - Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
FDA Device · Class II · 2019-07-03 · Ethicon Endo Surgery - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions
FDA Device · Class I · 2019-07-03 · Vyaire Medical - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05
FDA Device · Class II · 2019-07-03 · Thermo Fisher Scientific Asheville - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG…
FDA Device · Class III · 2019-07-03 · Ge Healthcare - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10
FDA Device · Class II · 2019-07-03 · Thermo Fisher Scientific Asheville - ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG…
FDA Device · Class III · 2019-07-03 · Ge Healthcare - Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
FDA Device · Class II · 2019-07-03 · Ethicon Endo Surgery - Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer i…
FDA Device · Class II · 2019-07-03 · Ge Healthcare - ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-…
FDA Device · Class III · 2019-07-03 · Ge 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)