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.
- EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a pa…
FDA Device · Class II · 2018-11-07 · Baxter Healthcare - Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to prod…
FDA Device · Class II · 2018-11-07 · Philips Medical Systems Cleveland - EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a p…
FDA Device · Class II · 2018-11-07 · Baxter Healthcare - Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of tr…
FDA Device · Class II · 2018-11-07 · Fresenius Vial - EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a p…
FDA Device · Class II · 2018-11-07 · Baxter Healthcare - Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic…
FDA Device · Class II · 2018-11-07 · Siemens Medical Solutions Usa - Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp
FDA Device · Class III · 2018-11-07 · Acumedia Manufacturers - FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test k…
FDA Device · Class II · 2018-11-07 · Biofire Diagnostics - Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc
FDA Device · Class III · 2018-11-07 · Beckman Coulter - EVO Excel, Emission Computed Tomographic System, Material Number 10910501
FDA Device · Class II · 2018-11-07 · Siemens Medical Solutions Usa - Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce c…
FDA Device · Class II · 2018-11-07 · Philips Medical Systems Cleveland - Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030
FDA Device · Class II · 2018-11-07 · Stryker - Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is…
FDA Device · Class III · 2018-11-07 · Beckman Coulter - Zilver 518 Biliary Stent 4mm x 30mm, Catalog Number: ZIB5-125-4.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for p…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectio…
FDA Device · Class II · 2018-11-07 · Philips Medical Systems Cleveland - Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended fo…
FDA Device · Class II · 2018-11-07 · Cook Medical - RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system
FDA Device · Class II · 2018-11-07 · Raysearch Laboratories Ab - Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liqu…
FDA Device · Class II · 2018-11-07 · Cmp Industries - Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040
FDA Device · Class II · 2018-11-07 · Stryker - Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for p…
FDA Device · Class II · 2018-11-07 · Cook Medical - Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH Sort…
FDA Device · Class III · 2018-11-07 · Beckman Coulter - BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appro…
FDA Device · Class II · 2018-11-07 · Becton Dickinson And - Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
FDA Device · Class I · 2018-11-07 · Maquet Datascope Cardiac Assist Division - AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Syst…
FDA Device · Class II · 2018-11-07 · Siemens Medical Solutions Usa - Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomo…
FDA Device · Class II · 2018-11-07 · Siemens Medical Solutions Usa - Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended fo…
FDA Device · Class II · 2018-11-07 · Cook Medical - Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-section…
FDA Device · Class II · 2018-11-07 · Philips Medical Systems Cleveland - Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical…
FDA Device · Class III · 2018-11-07 · Beckman Coulter - Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended fo…
FDA Device · Class II · 2018-11-07 · Cook Medical - Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-se…
FDA Device · Class II · 2018-11-07 · Philips Medical Systems Cleveland - Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for p…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for p…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers th…
FDA Device · Class II · 2018-11-07 · Arthrex - Arrow AGB + Multi-Lumen CVC Kit, Cat
FDA Device · Class II · 2018-11-07 · Arrow International - Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular s…
FDA Device · Class II · 2018-11-07 · Inpeco - Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020
FDA Device · Class II · 2018-11-07 · Stryker - Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042…
FDA Device · Class II · 2018-11-07 · Siemens Medical Solutions Usa - Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) in…
FDA Device · Class III · 2018-11-07 · Beckman Coulter - Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone…
FDA Device · Class I · 2018-11-07 · Zimmer Biomet - Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended fo…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended fo…
FDA Device · Class II · 2018-11-07 · Cook Medical - BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX Syste…
FDA Device · Class II · 2018-11-07 · Becton Dickinson And - IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce c…
FDA Device · Class II · 2018-11-07 · Philips Medical Systems Cleveland - Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for p…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended fo…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a p…
FDA Device · Class II · 2018-11-07 · Baxter Healthcare - Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc
FDA Device · Class III · 2018-11-07 · Beckman Coulter - Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010
FDA Device · Class II · 2018-11-07 · Stryker - Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion…
FDA Device · Class I · 2018-11-07 · Zimmer Biomet - IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306
FDA Device · Class II · 2018-11-07 · Cmp Industries - Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended fo…
FDA Device · Class II · 2018-11-07 · Cook Medical - BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
FDA Device · Class II · 2018-11-07 · Leica Microsystems - Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectio…
FDA Device · Class II · 2018-11-07 · Philips Medical Systems Cleveland - EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a…
FDA Device · Class II · 2018-11-07 · Baxter Healthcare - Magellan LeadCare¿ II Blood Lead Test Kit
FDA Device · Class II · 2018-11-07 · Magellan Diagnostics - 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and…
FDA Device · Class II · 2018-11-07 · 3m Health Care Business - Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc
FDA Device · Class III · 2018-11-07 · Beckman Coulter - Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for p…
FDA Device · Class II · 2018-11-07 · Cook Medical - CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc
FDA Device · Class II · 2018-10-31 · Nakanishi - APTIO INPUT/OUTPUT MODULE
FDA Device · Class II · 2018-10-31 · Siemens Healthcare Diagnostics - IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer s…
FDA Device · Class II · 2018-10-31 · Data Innovations - CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Su…
FDA Device · Class II · 2018-10-31 · Ecolab - O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging Sys…
FDA Device · Class II · 2018-10-31 · Medtronic Navigation Littleton - CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - APTIO CENTRIFUGE MODULE
FDA Device · Class II · 2018-10-31 · Siemens Healthcare Diagnostics - O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm…
FDA Device · Class II · 2018-10-31 · Medtronic Navigation Littleton - Tritanium TL Steerable Inserter, Cat
FDA Device · Class II · 2018-10-31 · Howmedica Osteonics - BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an aut…
FDA Device · Class II · 2018-10-31 · Biomerieux - CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - Mitek Screw and Washer Depth Gauge, Product Code 219024
FDA Device · Class II · 2018-10-31 · Depuy Mitek A Johnson And Johnson - Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc
FDA Device · Class II · 2018-10-31 · Nakanishi - STREAMLAB - REFRIGERATED STORAGE MODULE 15000
FDA Device · Class II · 2018-10-31 · Siemens Healthcare Diagnostics - CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc
FDA Device · Class II · 2018-10-31 · Nakanishi
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)