Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 162 of 548
FDA Devices Moderate Dec 8, 2021
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Randox Laboratories Ltd.
FDA Devices Moderate Dec 8, 2021
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Howmedica Osteonics Corp.
FDA Devices Moderate Dec 8, 2021
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BAC…
BioFire Diagnostics, LLC
FDA Devices Moderate Dec 8, 2021
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
O&M HALYARD INC
FDA Devices Moderate Dec 8, 2021
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
Boston Scientific Corporation
FDA Devices Moderate Dec 8, 2021
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23…
Magnolia Medical Technologies, Inc.
FDA Devices Moderate Dec 8, 2021
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Boston Scientific Corporation
FDA Devices Moderate Dec 8, 2021
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
Boston Scientific Corporation
FDA Devices Moderate Dec 8, 2021
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
Boston Scientific Corporation
FDA Devices Moderate Dec 8, 2021
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Thoratec Corp.
FDA Devices Moderate Dec 1, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product…
Philips North America Llc
FDA Devices Moderate Dec 1, 2021
Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), R…
Medtronic Neuromodulation
FDA Devices Moderate Dec 1, 2021
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model N…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Dec 1, 2021
Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
Western/Scott Fetzer Company
FDA Devices Moderate Dec 1, 2021
Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDU…
Medtronic Vascular, Inc.
FDA Devices Moderate Dec 1, 2021
Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
Western/Scott Fetzer Company
FDA Devices Moderate Dec 1, 2021
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Instrumentation Laboratory
FDA Devices Moderate Dec 1, 2021
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model N…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Dec 1, 2021
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Dec 1, 2021
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
The Binding Site Group, Ltd.
FDA Devices Moderate Dec 1, 2021
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and…
Intuitive Surgical, Inc.
FDA Devices Moderate Dec 1, 2021
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Medtronic Vascular, Inc.
FDA Devices Moderate Dec 1, 2021
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mo…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Dec 1, 2021
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Dec 1, 2021
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure …
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Dec 1, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or PET/C…
Philips North America Llc
FDA Devices Moderate Dec 1, 2021
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
Abbott Laboratories
FDA Devices Moderate Dec 1, 2021
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
Western/Scott Fetzer Company
FDA Devices Moderate Dec 1, 2021
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Dec 1, 2021
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
Medtronic Neuromodulation
FDA Devices Moderate Dec 1, 2021
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model …
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Dec 1, 2021
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal…
Atrium Medical Corporation
FDA Devices Moderate Dec 1, 2021
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mo…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Dec 1, 2021
Cardioblate CryoFlex Surgical Ablation Console
Medtronic Perfusion Systems
FDA Devices Moderate Dec 1, 2021
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter …
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Dec 1, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT produ…
Philips North America Llc
FDA Devices Moderate Dec 1, 2021
SOMATOM Force with software syngo.CT VB20 Model #10742326
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Dec 1, 2021
Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
Western/Scott Fetzer Company
FDA Devices Moderate Dec 1, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or P…
Philips North America Llc
FDA Devices Moderate Dec 1, 2021
SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Nov 24, 2021
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the …
Bio-Rad Laboratories, Inc.
FDA Devices Moderate Nov 24, 2021
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary …
Cordis Corporation
FDA Devices Moderate Nov 24, 2021
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
CooperSurgical, Inc.
FDA Devices Moderate Nov 24, 2021
REGARD Vitrectomy Tray
ROi CPS LLC
FDA Devices Moderate Nov 24, 2021
REGARD Ear Tray
ROi CPS LLC
FDA Devices Moderate Nov 24, 2021
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes …
Fujifilm Irvine Scientific, Inc.
FDA Devices Moderate Nov 24, 2021
Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer…
Roche Diagnostics Operations, Inc.
FDA Devices Moderate Nov 24, 2021
LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
CooperSurgical, Inc.
FDA Devices Moderate Nov 24, 2021
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
CooperSurgical, Inc.
FDA Devices Moderate Nov 24, 2021
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
CooperSurgical, Inc.