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.
- BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing…
FDA Device · Class II · 2021-04-28 · Biotronik - BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide ventricular tachycardia pacing and…
FDA Device · Class II · 2021-04-28 · Biotronik - BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing an…
FDA Device · Class II · 2021-04-28 · Biotronik - Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling
FDA Device · Class II · 2021-04-28 · Smiths Medical Asd - BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventricular tachycardia pa…
FDA Device · Class II · 2021-04-28 · Biotronik - ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
FDA Device · Class II · 2021-04-21 · Covidien - VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
FDA Device · Class II · 2021-04-21 · Hubo International - Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 17…
FDA Device · Class II · 2021-04-21 · Covidien - VIDAS¿ CMV IgM 30 Tests
FDA Device · Class II · 2021-04-21 · Biomerieux - Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catal…
FDA Device · Class II · 2021-04-21 · K2m - The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose
FDA Device · Class II · 2021-04-21 · Eos Imaging - Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualit…
FDA Device · Class II · 2021-04-21 · Remel - Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
FDA Device · Class II · 2021-04-21 · Krishe - SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
FDA Device · Class II · 2021-04-21 · Sunstar Americas - ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (…
FDA Device · Class II · 2021-04-21 · Raysearch Laboratories Ab - ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10…
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.…
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the pro…
FDA Device · Class II · 2021-04-21 · Arthrex - MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product…
FDA Device · Class II · 2021-04-21 · Vectornate Usa - ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualit…
FDA Device · Class II · 2021-04-21 · Remel - Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
FDA Device · Class II · 2021-04-21 · Covidien - ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE
FDA Device · Class II · 2021-04-21 · Krishe - Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specim…
FDA Device · Class II · 2021-04-21 · Medline Industries - ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3…
FDA Device · Class II · 2021-04-21 · Centinel Spine - Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: us…
FDA Device · Class II · 2021-04-21 · Stryker - ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in naso…
FDA Device · Class II · 2021-04-21 · Becton Dickinson And - Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
FDA Device · Class II · 2021-04-21 · Covidien - Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system
FDA Device · Class II · 2021-04-21 · Covidien - Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
FDA Device · Class II · 2021-04-21 · Krishe - ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
FDA Device · Class II · 2021-04-21 · Fujifilm Medical Systems U - cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
FDA Device · Class II · 2021-04-21 · Roche Molecular Systems - Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex
FDA Device · Class III · 2021-04-21 · Origen Biomedical - MAMBA Microcatheter
FDA Device · Class II · 2021-04-21 · Boston Scientific - ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Device · Class II · 2021-04-21 · Siemens Healthcare Diagnostics - MAMBA Flex 135 Microcatheter
FDA Device · Class II · 2021-04-21 · Boston Scientific - cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog…
FDA Device · Class II · 2021-04-21 · Roche Molecular Systems - Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
FDA Device · Class II · 2021-04-21 · Krishe - Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial,…
FDA Device · Class II · 2021-04-14 · Howmedica Osteonics - At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 6…
FDA Device · Class II · 2021-04-14 · Tenderneeds Fertility - Drop Arm Versamode"
FDA Device · Class II · 2021-04-14 · Gf Health Products - MicroScan WalkAway-96 plus Reconditioned Instrument
FDA Device · Class II · 2021-04-14 · Beckman Coulter - Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC m…
FDA Device · Class II · 2021-04-14 · Fujifilm Medical Systems U - Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells
FDA Device · Class II · 2021-04-14 · Fenwal - BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of b…
FDA Device · Class II · 2021-04-14 · Becton Dickinson And - CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking
FDA Device · Class II · 2021-04-14 · Integra Lifesciences - Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm wit…
FDA Device · Class II · 2021-04-14 · Terumo Cardiovascular Systems - Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-…
FDA Device · Class II · 2021-04-14 · Arrow International - NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, h…
FDA Device · Class II · 2021-04-14 · Nuvasive Specialized Orthopedics - NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Impla…
FDA Device · Class II · 2021-04-14 · Nuvasive Specialized Orthopedics - Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)
FDA Device · Class II · 2021-04-14 · Tenderneeds Fertility - Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
FDA Device · Class I · 2021-04-14 · Tenacore - Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 143…
FDA Device · Class I · 2021-04-14 · Heartware - Deluxe At Home Artificial Insemination Kit (SKU 636391205832)
FDA Device · Class II · 2021-04-14 · Tenderneeds Fertility - MicroScan WalkAway-40 plus Reconditioned Instrument
FDA Device · Class II · 2021-04-14 · Beckman Coulter - Pro Series Fertility Device (SKU 644042788139)
FDA Device · Class II · 2021-04-14 · Tenderneeds Fertility - EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity i…
FDA Device · Class II · 2021-04-14 · Clerio Vision - Medtronic HVAD Alarm Adapter, Product Number: 1450
FDA Device · Class I · 2021-04-14 · Heartware - Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 140…
FDA Device · Class I · 2021-04-14 · Heartware - Medtronic HVAD Monitor Data Cable, Product Number: 1575
FDA Device · Class I · 2021-04-14 · Heartware - Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
FDA Device · Class II · 2021-04-14 · Tenderneeds Fertility - Regard, Item Number 830067009, custom cardiovascular procedure kit
FDA Device · Class II · 2021-04-14 · Roi Cps - Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
FDA Device · Class I · 2021-04-14 · Heartware - BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bact…
FDA Device · Class II · 2021-04-14 · Becton Dickinson And - At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
FDA Device · Class II · 2021-04-14 · Tenderneeds Fertility - Premium At Home Pro Series Insemination Kit (SKU 644042787927)
FDA Device · Class II · 2021-04-14 · Tenderneeds Fertility - Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion S…
FDA Device · Class II · 2021-04-14 · Hologic - At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
FDA Device · Class II · 2021-04-14 · Tenderneeds Fertility - Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
FDA Device · Class II · 2021-04-14 · Tenderneeds Fertility - MicroScan WalkAway-96 plus Instrument
FDA Device · Class II · 2021-04-14 · Beckman Coulter - NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant
FDA Device · Class II · 2021-04-14 · Nuvasive Specialized Orthopedics - Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)
FDA Device · Class II · 2021-04-14 · Tenderneeds Fertility - SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
FDA Device · Class II · 2021-04-14 · Sharp Medical Products - A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Applic…
FDA Device · Class II · 2021-04-14 · Medtronic Neuromodulation - Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
FDA Device · Class I · 2021-04-14 · Tenacore - MicroScan WalkAway-40 plus Instrument
FDA Device · Class II · 2021-04-14 · Beckman Coulter - Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells
FDA Device · Class II · 2021-04-14 · Fenwal - Enteral Infusion Pump
FDA Device · Class II · 2021-04-14 · Cardinal Health 200 - Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511I…
FDA Device · Class I · 2021-04-14 · Heartware - Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, c…
FDA Device · Class II · 2021-04-14 · Siemens Medical Solutions Usa - Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells
FDA Device · Class II · 2021-04-14 · Fenwal - Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Ever…
FDA Device · Class I · 2021-04-07 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological param…
FDA Device · Class II · 2021-04-07 · Philips North America - Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-…
FDA Device · Class II · 2021-04-07 · Nuvasive Specialized Orthopedics
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)