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.
- LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias in…
FDA Device · Class II · 2021-05-12 · Lemaitre Vascular - Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with A…
FDA Device · Class II · 2021-05-12 · Medtronic Neuromodulation - CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED)
FDA Device · Class II · 2021-05-12 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral vein…
FDA Device · Class II · 2021-05-12 · Medtronic - VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: i…
FDA Device · Class II · 2021-05-12 · Greiner Bio One North America - Programmers - Product Usage: used to treat arrhythmias related to bradycardia
FDA Device · Class II · 2021-05-12 · Medtronic Cardiac Rhythm And Heart Failure Crhf - DJO EMPOWR KNEE Femoral Sizer
FDA Device · Class II · 2021-05-12 · Encore Medical - Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction…
FDA Device · Class II · 2021-05-12 · Oto Med - Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia
FDA Device · Class II · 2021-05-12 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a sucti…
FDA Device · Class II · 2021-05-12 · Oto Med - Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction…
FDA Device · Class II · 2021-05-12 · Oto Med - CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. So…
FDA Device · Class II · 2021-05-12 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images…
FDA Device · Class II · 2021-05-12 · Ge Healthcare - CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia
FDA Device · Class II · 2021-05-12 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia
FDA Device · Class II · 2021-05-12 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Power Wheelchair
FDA Device · Class II · 2021-05-05 · Merits Holdings - InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal…
FDA Device · Class II · 2021-05-05 · Nextremity Solutions - Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons
FDA Device · Class III · 2021-05-05 · Datascope - InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal…
FDA Device · Class II · 2021-05-05 · Nextremity Solutions - DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to…
FDA Device · Class II · 2021-05-05 · Dj Orthopedics De Mexico - VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer corre…
FDA Device · Class II · 2021-05-05 · Ortho Clinical Diagnostics - Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
FDA Device · Class II · 2021-05-05 · Siemens Medical Solutions Usa - Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare provide…
FDA Device · Class II · 2021-05-05 · Philips North America - Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization
FDA Device · Class II · 2021-05-05 · Cardiac Assist - Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids
FDA Device · Class II · 2021-05-05 · Baxter Healthcare - KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100
FDA Device · Class II · 2021-05-05 · Conmed - Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal…
FDA Device · Class II · 2021-05-05 · Omnia Srl - Change Healthcare Enterprise Viewer
FDA Device · Class II · 2021-05-05 · Change Healthcare Canada - UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposusp…
FDA Device · Class II · 2021-05-05 · Boston Scientific - Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used wit…
FDA Device · Class II · 2021-05-05 · Medela Ag Medical Technology - Filtered Triple-Leg Extension Set - Intravascular administration set
FDA Device · Class II · 2021-05-05 · B Braun Medical - Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons
FDA Device · Class III · 2021-05-05 · Datascope - DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobiliz…
FDA Device · Class II · 2021-05-05 · Dj Orthopedics De Mexico - Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents
FDA Device · Class II · 2021-05-05 · Cytocell - Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family…
FDA Device · Class II · 2021-05-05 · Siemens Medical Solutions Usa - Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes
FDA Device · Class II · 2021-05-05 · Coltene Whaledent - Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and m…
FDA Device · Class II · 2021-05-05 · Boston Scientific - DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes t…
FDA Device · Class II · 2021-05-05 · Dj Orthopedics De Mexico - DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immob…
FDA Device · Class II · 2021-05-05 · Dj Orthopedics De Mexico - Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures inc…
FDA Device · Class II · 2021-05-05 · Siemens Medical Solutions Usa - Scooter
FDA Device · Class II · 2021-05-05 · Merits Holdings - Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodi…
FDA Device · Class II · 2021-05-05 · Clark Laboratories - ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler c…
FDA Device · Class II · 2021-05-05 · Smiths Medical Asd - INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100
FDA Device · Class II · 2021-05-05 · Conmed - EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observ…
FDA Device · Class III · 2021-05-05 · Boston Scientific - VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology
FDA Device · Class II · 2021-05-05 · Luminex - CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts i…
FDA Device · Class II · 2021-05-05 · Smith And Nephew - Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree
FDA Device · Class II · 2021-05-05 · Smiths Medical Asd - BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing an…
FDA Device · Class II · 2021-04-28 · Biotronik - Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transd…
FDA Device · Class II · 2021-04-28 · Smiths Medical Asd - Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressi…
FDA Device · Class II · 2021-04-28 · Trinity Sterile - Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage:…
FDA Device · Class II · 2021-04-28 · Medtronic Sofamor Danek Usa - HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of…
FDA Device · Class II · 2021-04-28 · Smiths Medical Asd - Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE,…
FDA Device · Class II · 2021-04-28 · Smiths Medical Asd - AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of va…
FDA Device · Class II · 2021-04-28 · Angiodynamics Navilyst Medical - Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage:…
FDA Device · Class II · 2021-04-28 · Medtronic Sofamor Danek Usa - Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model…
FDA Device · Class II · 2021-04-28 · Smiths Medical Asd - BCS XP System: Multipurpose system for in vitro coagulation studies
FDA Device · Class II · 2021-04-28 · Siemens Healthcare Diagnostics - Instructions for Use and Patient Manual for HeartWare HVAD System
FDA Device · Class II · 2021-04-28 · Heartware - ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory
FDA Device · Class II · 2021-04-28 · Welch Allyn Mortara - BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacin…
FDA Device · Class II · 2021-04-28 · Biotronik - HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component)
FDA Device · Class II · 2021-04-28 · Smiths Medical Asd - ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory
FDA Device · Class II · 2021-04-28 · Welch Allyn Mortara - BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing and…
FDA Device · Class II · 2021-04-28 · Biotronik - BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ven…
FDA Device · Class II · 2021-04-28 · Biotronik - BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia…
FDA Device · Class II · 2021-04-28 · Biotronik - Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory
FDA Device · Class II · 2021-04-28 · Welch Allyn Mortara - ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures
FDA Device · Class II · 2021-04-28 · Smiths Medical Asd - LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring
FDA Device · Class II · 2021-04-28 · Smiths Medical Asd - BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and vent…
FDA Device · Class II · 2021-04-28 · Biotronik - Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer
FDA Device · Class II · 2021-04-28 · Smiths Medical Asd - Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161…
FDA Device · Class II · 2021-04-28 · Siemens Medical Solutions Usa - The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline
FDA Device · Class II · 2021-04-28 · Boston Scientific - BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and vent…
FDA Device · Class II · 2021-04-28 · Biotronik - Instructions for Use and Patient Manual for HeartWare HVAD System
FDA Device · Class II · 2021-04-28 · Heartware - DirectInject consists of a sterile dual paste system which is calcium phosphate based
FDA Device · Class II · 2021-04-28 · Stryker Leibinger And Kg - Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids
FDA Device · Class II · 2021-04-28 · Smiths Medical Asd - BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ven…
FDA Device · Class II · 2021-04-28 · Biotronik - BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular tachycardia pacing an…
FDA Device · Class II · 2021-04-28 · Biotronik - Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-1…
FDA Device · Class II · 2021-04-28 · Azure Biotech - BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pac…
FDA Device · Class II · 2021-04-28 · Biotronik - Left Heart Kit, Model Number M20268. for blood pressure monitoring
FDA Device · Class II · 2021-04-28 · Smiths Medical Asd - BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and ven…
FDA Device · Class II · 2021-04-28 · Biotronik - Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
FDA Device · Class I · 2021-04-28 · Pacific Medical Group - BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing a…
FDA Device · Class II · 2021-04-28 · Biotronik - BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventr…
FDA Device · Class II · 2021-04-28 · Biotronik - BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tachycardia pacing and…
FDA Device · Class II · 2021-04-28 · Biotronik - Instructions for Use and Patient Manual for HeartWare HVAD System
FDA Device · Class I · 2021-04-28 · Heartware - BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pac…
FDA Device · Class II · 2021-04-28 · Biotronik - BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and…
FDA Device · Class II · 2021-04-28 · Biotronik - Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar
FDA Device · Class II · 2021-04-28 · Stryker Spine - BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacin…
FDA Device · Class II · 2021-04-28 · Biotronik - BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ven…
FDA Device · Class II · 2021-04-28 · Biotronik - BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing a…
FDA Device · Class II · 2021-04-28 · Biotronik - Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access o…
FDA Device · Class II · 2021-04-28 · Angiodynamics Navilyst Medical - AM12M Acquisition Module accessory
FDA Device · Class II · 2021-04-28 · Welch Allyn Mortara - BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage: intended to provide ventricular tachycardia pacing…
FDA Device · Class II · 2021-04-28 · Biotronik - Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only
FDA Device · Class II · 2021-04-28 · C R Bard - LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling
FDA Device · Class II · 2021-04-28 · Smiths Medical Asd - BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tachycardia pacing and…
FDA Device · Class II · 2021-04-28 · Biotronik
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)