FDA Device · 2018
FDA Device recalls in 2018
RecallRadar indexes 3,757 FDA Device recall notices published in 2018. By classification: 136 Class I, 3,529 Class II, 92 Class III.
- ST-AIA PACK SHBG
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label
FDA Device · Class II · 2018-06-13 · Orthofix - ST-AIA PACK CEA
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (includ…
FDA Device · Class II · 2018-06-13 · Ge Healthcare - Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
FDA Device · Class III · 2018-06-13 · Datascope - nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physi…
FDA Device · Class II · 2018-06-13 · Nordicneurolab As - Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
FDA Device · Class II · 2018-06-13 · C R Bard - Hobbs Bronchial Cytology Brushes, Model Number 4202
FDA Device · Class II · 2018-06-13 · Hobbs Medical - ST-AIA PACK LH II
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ST-AIA PACK FT4
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev
FDA Device · Class II · 2018-06-13 · Microaire Surgical Instruments - ST-AIA PACK FSH
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ST-AIA PACK HCG
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001)
FDA Device · Class II · 2018-06-13 · Orthofix - T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001)
FDA Device · Class II · 2018-06-13 · Orthofix - L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L)
FDA Device · Class II · 2018-06-13 · Orthofix - Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008)
FDA Device · Class II · 2018-06-13 · Orthofix - CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020)
FDA Device · Class II · 2018-06-13 · Orthofix - VPS Rhythm ECG Accessory Pack with Johans Adapter
FDA Device · Class II · 2018-06-06 · Arrow International - Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal B…
FDA Device · Class II · 2018-06-06 · Arrow International - Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
FDA Device · Class II · 2018-06-06 · Arrow International - HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) P…
FDA Device · Class II · 2018-06-06 · Philips Electronics North America - ARROW PICC Set
FDA Device · Class II · 2018-06-06 · Arrow International - Spring Wire Guide Introducer Needle
FDA Device · Class II · 2018-06-06 · Arrow International - HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usag…
FDA Device · Class II · 2018-06-06 · Ethicon Endo Surgery - 7Fr. Catheter Clamp with Fastener
FDA Device · Class II · 2018-06-06 · Arrow International - Pressure Injectable Multi-Lumen Central Venous Catheterization Kit
FDA Device · Class II · 2018-06-06 · Arrow International - Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use i…
FDA Device · Class II · 2018-06-06 · Siemens Healthcare Diagnostics - Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Cath…
FDA Device · Class II · 2018-06-06 · Arrow International - Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal B…
FDA Device · Class II · 2018-06-06 · Arrow International - Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features
FDA Device · Class II · 2018-06-06 · Arrow International - Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters
FDA Device · Class II · 2018-06-06 · Arrow International - ARROW JACC with Chlorag+ard Technology
FDA Device · Class II · 2018-06-06 · Arrow International - Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features
FDA Device · Class II · 2018-06-06 · Arrow International - LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only
FDA Device · Class II · 2018-06-06 · Torax Medical - LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only
FDA Device · Class II · 2018-06-06 · Torax Medical - MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor
FDA Device · Class II · 2018-06-06 · Roche Molecular Systems - Pressure Injectable Multi-Lumen Central Venous Catheterization Kit
FDA Device · Class II · 2018-06-06 · Arrow International - LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only
FDA Device · Class II · 2018-06-06 · Torax Medical - Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires
FDA Device · Class II · 2018-06-06 · Arrow International - nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to ph…
FDA Device · Class II · 2018-06-06 · Nordicneurolab As - ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters
FDA Device · Class II · 2018-06-06 · Arrow International - Respire Pink+ Hard/Soft Oral Sleep Apnea Device
FDA Device · Class II · 2018-06-06 · Respire Medical - Radial Artery Catheterization Kit
FDA Device · Class II · 2018-06-06 · Arrow International - Maximal Barrier Drape
FDA Device · Class II · 2018-06-06 · Arrow International - LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only
FDA Device · Class II · 2018-06-06 · Torax Medical - 8Fr. Catheter Clamp with Fastener
FDA Device · Class II · 2018-06-06 · Arrow International - MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F Product Usage: A needle counter is intended to be used safel…
FDA Device · Class II · 2018-06-06 · Medline Industries - Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip¿, ARROWg+ard Blue PLUS¿ Catheter, Sharps Safety Featur…
FDA Device · Class II · 2018-06-06 · Arrow International - ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters
FDA Device · Class II · 2018-06-06 · Arrow International - SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans
FDA Device · Class II · 2018-06-06 · Siemens Medical Solutions Usa - LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only
FDA Device · Class II · 2018-06-06 · Torax Medical - ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit
FDA Device · Class II · 2018-06-06 · Arrow International - Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal…
FDA Device · Class II · 2018-06-06 · Arrow International - Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regu…
FDA Device · Class II · 2018-06-06 · Dynarex - Extension Line Slide Clamps
FDA Device · Class II · 2018-06-06 · Arrow International - Maximal Barrier Drape
FDA Device · Class II · 2018-06-06 · Arrow International - nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians
FDA Device · Class II · 2018-06-06 · Nordicneurolab As - PICC Catheter Trimmer
FDA Device · Class II · 2018-06-06 · Arrow International - Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters
FDA Device · Class II · 2018-06-06 · Arrow International - ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 (c) PROCAIR PLUS 84" MA…
FDA Device · Class II · 2018-06-06 · Joerns Healthcare - Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conduct…
FDA Device · Class II · 2018-06-06 · Gyrus Acmi - Radial Arterial Access Kit
FDA Device · Class II · 2018-06-06 · Arrow International - Respire Pink H/S Oral Sleep Apnea Device
FDA Device · Class II · 2018-06-06 · Respire Medical - MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for…
FDA Device · Class II · 2018-06-06 · Arrow International - SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans
FDA Device · Class II · 2018-06-06 · Siemens Medical Solutions Usa - ARROW PICC Set
FDA Device · Class II · 2018-06-06 · Arrow International - Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters
FDA Device · Class II · 2018-06-06 · Arrow International - Medical Action Industries Inc
FDA Device · Class II · 2018-06-06 · Medical Action Industries - MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usag…
FDA Device · Class II · 2018-06-06 · Medline Industries - VPS TipTracker Stylet Accessory
FDA Device · Class II · 2018-06-06 · Arrow International - Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Bar…
FDA Device · Class II · 2018-06-06 · Arrow International - Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipol…
FDA Device · Class II · 2018-06-06 · Olsen Medical - Arterial Catheterization Kit
FDA Device · Class II · 2018-06-06 · Arrow International - Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety…
FDA Device · Class II · 2018-06-06 · Arrow International - MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam…
FDA Device · Class II · 2018-06-06 · Medline Industries - Carina Ventilator, ventilator
FDA Device · Class II · 2018-06-06 · Draeger Medical - 10 cc Luer-Slip Loss of Resistance Syringe
FDA Device · Class II · 2018-06-06 · Arrow International - AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
FDA Device · Class II · 2018-06-06 · Wrp Asia Pacific Sdn Bhd - Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrie…
FDA Device · Class II · 2018-06-06 · Arrow International - Arrow PICC with Chlorag+ard Technology
FDA Device · Class II · 2018-06-06 · Arrow International - Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 -…
FDA Device · Class II · 2018-06-06 · Arrow International - Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet F…
FDA Device · Class II · 2018-06-06 · Olsen Medical - Respire Pink H/S Oral Sleep Apnea Device
FDA Device · Class II · 2018-06-06 · Respire Medical - TheraCath(R) Epidural Catheter
FDA Device · Class II · 2018-06-06 · Arrow International - P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3…
FDA Device · Class II · 2018-06-06 · Joerns Healthcare - Arterial Catheterization Kit
FDA Device · Class II · 2018-06-06 · Arrow International - Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile
FDA Device · Class II · 2018-06-06 · Ad Tech Medical Instrument - Radial Artery Catheterization Kit with Sharps Safety Features
FDA Device · Class II · 2018-06-06 · Arrow International - Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features
FDA Device · Class II · 2018-06-06 · Arrow International - ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit
FDA Device · Class II · 2018-06-06 · Arrow International - Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulat…
FDA Device · Class II · 2018-06-06 · Olsen Medical - Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety F…
FDA Device · Class II · 2018-06-06 · Arrow International - Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovi…
FDA Device · Class II · 2018-06-06 · Olsen Medical - Continuous Nerve Block Needle
FDA Device · Class II · 2018-06-06 · Arrow International - ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter
FDA Device · Class II · 2018-06-06 · Arrow International - Sternal Valve Retractors With Atrial and Aortic Rakes
FDA Device · Class II · 2018-06-06 · Genesee Biomedical - Maximal Barrier Drape
FDA Device · Class II · 2018-06-06 · Arrow International - Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features
FDA Device · Class II · 2018-06-06 · Arrow International - Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Bla…
FDA Device · Class II · 2018-06-06 · Olsen Medical
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)