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.
- EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB30…
FDA Device · Class II · 2021-04-07 · Epix Therapeutics - Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulm…
FDA Device · Class I · 2021-04-07 · Medtronic Perfusion Systems - ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusi…
FDA Device · Class I · 2021-04-07 · Smisson Cartledge Biomedical - AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads a…
FDA Device · Class II · 2021-04-07 · Oscor - ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusi…
FDA Device · Class I · 2021-04-07 · Smisson Cartledge Biomedical - EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT10…
FDA Device · Class II · 2021-04-07 · Epix Therapeutics - Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Device · Class II · 2021-04-07 · Alcon Research - EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT20…
FDA Device · Class II · 2021-04-07 · Epix Therapeutics - BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring o…
FDA Device · Class II · 2021-04-07 · Covidien - BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad
FDA Device · Class I · 2021-04-07 · Carefusion 303 - The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibi…
FDA Device · Class II · 2021-04-07 · Depuy Orthopaedics - Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures
FDA Device · Class II · 2021-04-07 · Arthrex - EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB40…
FDA Device · Class II · 2021-04-07 · Epix Therapeutics - Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad C…
FDA Device · Class I · 2021-04-07 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia D…
FDA Device · Class II · 2021-04-07 · Siemens Medical Solutions Usa - PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions,…
FDA Device · Class II · 2021-04-07 · Nuvasive Specialized Orthopedics - ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusi…
FDA Device · Class I · 2021-04-07 · Smisson Cartledge Biomedical - BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version…
FDA Device · Class II · 2021-04-07 · Biocare Medical - LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of p…
FDA Device · Class II · 2021-04-07 · Diasorin - CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of…
FDA Device · Class II · 2021-04-07 · Covidien - Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SA…
FDA Device · Class II · 2021-04-07 · Lumiradx - PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, o…
FDA Device · Class II · 2021-04-07 · Nuvasive Specialized Orthopedics - The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the f…
FDA Device · Class II · 2021-04-07 · Depuy Orthopaedics - EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT…
FDA Device · Class II · 2021-04-07 · Epix Therapeutics - Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a va…
FDA Device · Class II · 2021-04-07 · Hollister - Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2021-04-07 · Stryker Sustainability Solutions - EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT1…
FDA Device · Class II · 2021-04-07 · Epix Therapeutics - ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace t…
FDA Device · Class II · 2021-04-07 · Depuy Orthopaedics - In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery
FDA Device · Class II · 2021-03-31 · In2bones Sas - Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)108468…
FDA Device · Class II · 2021-03-31 · Biosense Webster - Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT)
FDA Device · Class II · 2021-03-31 · Baxter Healthcare - Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Cerami…
FDA Device · Class II · 2021-03-31 · Corin - Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT)
FDA Device · Class II · 2021-03-31 · Baxter Healthcare - RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal…
FDA Device · Class II · 2021-03-31 · Teleflex Medical - In-View Clear Leggings Bulk Non-Sterile
FDA Device · Class II · 2021-03-31 · Cardinal Health 200 - S-Series Equipment Management System
FDA Device · Class II · 2021-03-31 · Stryker Communications - Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a…
FDA Device · Class II · 2021-03-31 · Mizuho Osi - VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, a…
FDA Device · Class II · 2021-03-31 · Biomerieux - In-View Clear Leggings Sterile
FDA Device · Class II · 2021-03-31 · Cardinal Health 200 - Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceram…
FDA Device · Class II · 2021-03-31 · Corin - VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only)
FDA Device · Class II · 2021-03-31 · Ortho Clinical Diagnostics - Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipme…
FDA Device · Class II · 2021-03-31 · Olympus - RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering can…
FDA Device · Class II · 2021-03-31 · Raysearch Laboratories Ab - The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of re…
FDA Device · Class II · 2021-03-31 · Meridian Bioscience - Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)108468…
FDA Device · Class II · 2021-03-31 · Biosense Webster - Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnos…
FDA Device · Class II · 2021-03-31 · Hitachi Medical Systems America - BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid…
FDA Device · Class II · 2021-03-31 · Bard Peripheral Vascular - VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated…
FDA Device · Class II · 2021-03-31 · Biomerieux - Operating Table System
FDA Device · Class II · 2021-03-31 · Getinge Group Logistics America - Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT)
FDA Device · Class II · 2021-03-31 · Baxter Healthcare - PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drai…
FDA Device · Class II · 2021-03-31 · Teleflex Medical - Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures…
FDA Device · Class II · 2021-03-31 · Siemens Medical Solutions Usa - Femoral Angiography Drape Bulk Non-Sterile
FDA Device · Class II · 2021-03-31 · Cardinal Health 200 - CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxid…
FDA Device · Class II · 2021-03-31 · Caire Diagnostics - In-View Clear Leggings Sterile Non-Sterile
FDA Device · Class II · 2021-03-31 · Cardinal Health 200 - Femoral Angiography Drape Sterile
FDA Device · Class II · 2021-03-31 · Cardinal Health 200 - Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for…
FDA Device · Class II · 2021-03-31 · Baxter Healthcare - Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846…
FDA Device · Class II · 2021-03-31 · Biosense Webster - RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers
FDA Device · Class II · 2021-03-24 · Medline Industries - Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet
FDA Device · Class II · 2021-03-24 · Merit Medical Systems - Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Bala…
FDA Device · Class I · 2021-03-24 · Medtronic Perfusion Systems - Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm)
FDA Device · Class II · 2021-03-24 · Cardinal Health 200 - Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 2…
FDA Device · Class II · 2021-03-24 · Canon Medical System Usa - Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
FDA Device · Class II · 2021-03-24 · Siemens Healthcare Diagnostics - Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Bi…
FDA Device · Class I · 2021-03-24 · Medtronic Perfusion Systems - PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC…
FDA Device · Class I · 2021-03-24 · Cordis - Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) wit…
FDA Device · Class I · 2021-03-24 · Medtronic Perfusion Systems - McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or withdraw fluids from,…
FDA Device · Class II · 2021-03-24 · Cardinal Health 200 - Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system))
FDA Device · Class II · 2021-03-24 · R And D Systems - HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet
FDA Device · Class II · 2021-03-24 · Merit Medical Systems - Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balan…
FDA Device · Class I · 2021-03-24 · Medtronic Perfusion Systems - Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)S…
FDA Device · Class II · 2021-03-24 · Siemens Medical Solutions Usa - Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) appl…
FDA Device · Class II · 2021-03-24 · Philips Healthcare Suzhou - JUDKINS PACK
FDA Device · Class II · 2021-03-24 · Cardinal Health 200 - Incisive CT Computed Tomography X-ray System Model: 728143
FDA Device · Class II · 2021-03-24 · Philips North America - Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 2…
FDA Device · Class II · 2021-03-24 · Canon Medical System Usa - Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a sin…
FDA Device · Class I · 2021-03-24 · Medtronic Perfusion Systems - VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic
FDA Device · Class II · 2021-03-24 · Ortho Clinical Diagnostics - Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface…
FDA Device · Class I · 2021-03-24 · Medtronic Perfusion Systems - Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI…
FDA Device · Class I · 2021-03-24 · Medtronic Perfusion Systems - SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use
FDA Device · Class II · 2021-03-24 · Sirtex Medical - Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir…
FDA Device · Class I · 2021-03-24 · Medtronic Perfusion Systems - Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a…
FDA Device · Class I · 2021-03-24 · Medtronic Perfusion Systems - Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm)
FDA Device · Class II · 2021-03-24 · Cardinal Health 200 - Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of…
FDA Device · Class II · 2021-03-24 · Carestream Dental - Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is li…
FDA Device · Class II · 2021-03-24 · Epimed International - VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with…
FDA Device · Class II · 2021-03-24 · Ortho Clinical Diagnostics - Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
FDA Device · Class II · 2021-03-24 · Imactis - CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for l…
FDA Device · Class II · 2021-03-24 · Accuray - Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE…
FDA Device · Class I · 2021-03-24 · Medtronic Perfusion Systems - Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 2…
FDA Device · Class II · 2021-03-24 · Canon Medical System Usa - Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the follo…
FDA Device · Class II · 2021-03-24 · Mindray Ds Usa - CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascula…
FDA Device · Class II · 2021-03-17 · Medical Components - CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients w…
FDA Device · Class II · 2021-03-17 · Getinge Group Logistics America - CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology
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