FDA Device · 2021
FDA Device recalls in 2021
RecallRadar indexes 2,303 FDA Device recall notices published in 2021. By classification: 179 Class I, 2,098 Class II, 26 Class III.
- 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
FDA Device · Class II · 2021-12-08 · Howmedica Osteonics - HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
FDA Device · Class II · 2021-12-08 · Boston Scientific - The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in…
FDA Device · Class II · 2021-12-08 · Max Lux - HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
FDA Device · Class II · 2021-12-08 · Boston Scientific - NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-0…
FDA Device · Class II · 2021-12-08 · Nuvasive Specialized Orthopedics - INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
FDA Device · Class II · 2021-12-08 · Wright Medical Technology - RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
FDA Device · Class II · 2021-12-08 · Randox Laboratories - GE Centricity Universal Viewer Zero Footprint Client
FDA Device · Class II · 2021-12-08 · Ge Healthcare - BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 4420…
FDA Device · Class II · 2021-12-08 · Biofire Diagnostics - Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and…
FDA Device · Class II · 2021-12-08 · Siemens Healthcare Diagnostics - The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 27…
FDA Device · Class II · 2021-12-08 · Magnolia Medical Technologies - Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
FDA Device · Class II · 2021-12-01 · Western Scott Fetzer - Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mod…
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure…
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - SOMATOM Drive with software syngo.CT VB20 Model #10431700
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
FDA Device · Class II · 2021-12-01 · Ge Healthcare - Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C…
FDA Device · Class II · 2021-12-01 · Medtronic Vascular - Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neuros…
FDA Device · Class II · 2021-12-01 · Medtronic Neuromodulation - SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - CombiDiagnost R90 is multi-functional general R/F systems
FDA Device · Class II · 2021-12-01 · Philips Healthcare - Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mode…
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
FDA Device · Class II · 2021-12-01 · Philips Healthcare - Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
FDA Device · Class II · 2021-12-01 · Western Scott Fetzer - Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional proce…
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - 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…
FDA Device · Class II · 2021-12-01 · The Binding Site Group - Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure M…
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mod…
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedur…
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
FDA Device · Class II · 2021-12-01 · Medtronic Vascular - HemosIL ReadiPlasTin (20 mL), Part number 0020301400
FDA Device · Class II · 2021-12-01 · Instrumentation Laboratory - 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…
FDA Device · Class II · 2021-12-01 · Philips North America - SOMATOM Confidence with software syngo.CT VB20 Model #10590100
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87
FDA Device · Class II · 2021-12-01 · Abbott Laboratories - Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure M…
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimula…
FDA Device · Class II · 2021-12-01 · Medtronic Neuromodulation - The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart…
FDA Device · Class II · 2021-12-01 · Intuitive Surgical - Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
FDA Device · Class II · 2021-12-01 · Western Scott Fetzer - SOMATOM Force with software syngo.CT VB20 Model #10742326
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF281…
FDA Device · Class II · 2021-12-01 · Medtronic Vascular - Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
FDA Device · Class II · 2021-12-01 · Western Scott Fetzer - ProxiDiagnost N90 is multi-functional general R/F systems
FDA Device · Class II · 2021-12-01 · Philips Healthcare - Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or…
FDA Device · Class II · 2021-12-01 · Philips North America - BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min
FDA Device · Class II · 2021-12-01 · Becton Dickinson Infusion Therapy Systems - Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model…
FDA Device · Class II · 2021-12-01 · Medtronic Neuromodulation - Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure M…
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable car…
FDA Device · Class II · 2021-12-01 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or…
FDA Device · Class II · 2021-12-01 · Philips North America - Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mod…
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - Cardioblate CryoFlex Surgical Ablation Console
FDA Device · Class II · 2021-12-01 · Medtronic Perfusion Systems - Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a C…
FDA Device · Class II · 2021-12-01 · Philips North America - SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
FDA Device · Class II · 2021-12-01 · Siemens Medical Solutions Usa - 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…
FDA Device · Class II · 2021-12-01 · Philips North America - ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25
FDA Device · Class II · 2021-12-01 · Abbott Laboratories - DigitalDiagnost C90
FDA Device · Class II · 2021-12-01 · Philips Healthcare - The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device
FDA Device · Class II · 2021-12-01 · Atrium Medical - REGARD Vitrectomy Tray
FDA Device · Class II · 2021-11-24 · Roi Cps - Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
FDA Device · Class II · 2021-11-24 · Coopersurgical - SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the…
FDA Device · Class II · 2021-11-24 · Cordis - Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instr…
FDA Device · Class II · 2021-11-24 · Laboratoires Bodycad - Transseptal Needle with Catheter
FDA Device · Class II · 2021-11-24 · Cook - BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow im…
FDA Device · Class II · 2021-11-24 · Bio Rad Laboratories - REGARD Ultrasound Tray
FDA Device · Class II · 2021-11-24 · Roi Cps - Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
FDA Device · Class I · 2021-11-24 · Scrip - REGARD Core Biopsy Tray
FDA Device · Class II · 2021-11-24 · Roi Cps - bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809…
FDA Device · Class II · 2021-11-24 · Beaver Visitec International - Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
FDA Device · Class II · 2021-11-24 · Coopersurgical - Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
FDA Device · Class I · 2021-11-24 · Scrip - Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down
FDA Device · Class II · 2021-11-24 · Beaver Visitec International - Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN…
FDA Device · Class II · 2021-11-24 · Fujifilm Irvine Scientific - Permobil TiLite, Models: Aero Z, and ZRA
FDA Device · Class II · 2021-11-24 · Tisport - 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…
FDA Device · Class II · 2021-11-24 · Cordis - Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile
FDA Device · Class II · 2021-11-24 · Smith And Nephew - LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
FDA Device · Class II · 2021-11-24 · Coopersurgical - Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
FDA Device · Class II · 2021-11-24 · Medicalplastic S R L - SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in th…
FDA Device · Class II · 2021-11-24 · Cordis - REGARD Newborn Tray
FDA Device · Class II · 2021-11-24 · Roi Cps - OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total h…
FDA Device · Class II · 2021-11-24 · Omnilife Science - LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
FDA Device · Class II · 2021-11-24 · Coopersurgical - LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
FDA Device · Class II · 2021-11-24 · Coopersurgical - bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sampl…
FDA Device · Class II · 2021-11-24 · Beaver Visitec International - BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended…
FDA Device · Class II · 2021-11-24 · Bio Rad Laboratories - API 50 CH, Model 50300
FDA Device · Class II · 2021-11-24 · Biomerieux - LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
FDA Device · Class II · 2021-11-24 · Coopersurgical - Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Th…
FDA Device · Class I · 2021-11-24 · Arrow International - bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife…
FDA Device · Class II · 2021-11-24 · Beaver Visitec International - Transseptal Needle, Trocar
FDA Device · Class II · 2021-11-24 · Cook - Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN…
FDA Device · Class II · 2021-11-24 · Fujifilm Irvine Scientific - VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3…
FDA Device · Class III · 2021-11-24 · Ortho Clinical Diagnostics - SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the…
FDA Device · Class II · 2021-11-24 · Cordis - REGARD Ear Tray
FDA Device · Class II · 2021-11-24 · Roi Cps - Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Th…
FDA Device · Class I · 2021-11-24 · Arrow International - Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Comb…
FDA Device · Class II · 2021-11-24 · Siemens Medical Solutions Usa - Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous…
FDA Device · Class I · 2021-11-24 · Arrow International - Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thr…
FDA Device · Class I · 2021-11-24 · Arrow International - SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the b…
FDA Device · Class II · 2021-11-24 · Cordis - Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
FDA Device · Class II · 2021-11-24 · Coopersurgical - REGARD Basic Cataract tray
FDA Device · Class II · 2021-11-24 · Roi Cps - Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine…
FDA Device · Class II · 2021-11-24 · Roche Diagnostics Operations
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