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.
- Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therap…
FDA Device · Class II · 2021-02-03 · Medtronic Cardiac Rhythm And Heart Failure Crhf - PSG-1100 Sleep Diagnostic System
FDA Device · Class II · 2021-02-03 · Nihon Kohden America - SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner
FDA Device · Class II · 2021-02-03 · Omnilife Science - Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-…
FDA Device · Class II · 2021-02-03 · Respironics California - DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left)
FDA Device · Class II · 2021-02-03 · Neocis - ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
FDA Device · Class II · 2021-02-03 · Philips Home Healthcare Solution - Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 1…
FDA Device · Class II · 2021-02-03 · Hardy Diagnostics - therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment…
FDA Device · Class II · 2021-02-03 · Qiagen Sciences - TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439
FDA Device · Class II · 2021-02-03 · Philips North America - SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner
FDA Device · Class II · 2021-02-03 · Omnilife Science - Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
FDA Device · Class II · 2021-02-03 · Enztec - Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
FDA Device · Class II · 2021-02-03 · K2m - Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-…
FDA Device · Class II · 2021-02-03 · Respironics California - B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sa…
FDA Device · Class II · 2021-02-03 · Braxton Medical - Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf P…
FDA Device · Class II · 2021-02-03 · Fujifilm Medical Systems U - Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only…
FDA Device · Class II · 2021-02-03 · Stryker Sustainability Solutions - EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System
FDA Device · Class II · 2021-02-03 · Boston Scientific - Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respiron…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-…
FDA Device · Class II · 2021-02-03 · Respironics California - Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high densi…
FDA Device · Class III · 2021-02-03 · Fujifilm Medical Systems U - Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respiron…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner
FDA Device · Class II · 2021-02-03 · Omnilife Science - Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respiron…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231
FDA Device · Class II · 2021-02-03 · Philips North America - Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and B…
FDA Device · Class II · 2021-02-03 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resyn…
FDA Device · Class II · 2021-02-03 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Equinoxe Humeral Stem, Primary, Press Fit, 11mm
FDA Device · Class II · 2021-01-27 · Exactech - REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Ass…
FDA Device · Class II · 2021-01-27 · Medtronic Neurosurgery - Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and…
FDA Device · Class II · 2021-01-27 · Abbott Point - Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a c…
FDA Device · Class I · 2021-01-27 · Penumbra - OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a…
FDA Device · Class II · 2021-01-27 · Skeletal Kinetics - A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catal…
FDA Device · Class II · 2021-01-27 · Roche Diagnostics Operations - REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Ass…
FDA Device · Class II · 2021-01-27 · Medtronic Neurosurgery - Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Thera…
FDA Device · Class II · 2021-01-27 · Smiths Medical Asd - EMBLEM S-ICD Subcutaneous Electrode Model 3501
FDA Device · Class I · 2021-01-27 · Boston Scientific - Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hemato…
FDA Device · Class II · 2021-01-27 · Abbott Point - Synapse PACS Software Versions 5.1 and higher
FDA Device · Class II · 2021-01-27 · Fujifilm Medical Systems U - ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary ven…
FDA Device · Class II · 2021-01-27 · Boston Scientific - REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Ass…
FDA Device · Class II · 2021-01-27 · Medtronic Neurosurgery - Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with…
FDA Device · Class I · 2021-01-27 · Penumbra - uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
FDA Device · Class II · 2021-01-27 · Roche Molecular Systems - Neurosign 100, Product Number 9883-01
FDA Device · Class II · 2021-01-27 · The Magstim - OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone v…
FDA Device · Class II · 2021-01-27 · Skeletal Kinetics - Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of…
FDA Device · Class II · 2021-01-27 · Steris - A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteot…
FDA Device · Class II · 2021-01-27 · Biomet - Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7…
FDA Device · Class I · 2021-01-27 · Penumbra - Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for i…
FDA Device · Class II · 2021-01-27 · Laerdal Medical Suzhou - ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only
FDA Device · Class II · 2021-01-27 · Beckman Coulter - Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtr…
FDA Device · Class I · 2021-01-27 · Penumbra - GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of rad…
FDA Device · Class II · 2021-01-20 · Ge Healthcare - Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during t…
FDA Device · Class II · 2021-01-20 · Steris - NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic…
FDA Device · Class II · 2021-01-20 · Roche Molecular Systems - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100…
FDA Device · Class II · 2021-01-20 · Ge Healthcare - CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Soft…
FDA Device · Class II · 2021-01-20 · Medtronic - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
FDA Device · Class II · 2021-01-20 · Remel - VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum an…
FDA Device · Class II · 2021-01-20 · Ortho Clinical Diagnostics - Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 0871472…
FDA Device · Class I · 2021-01-20 · Boston Scientific - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radiois…
FDA Device · Class II · 2021-01-20 · Ge Healthcare - Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 0871472…
FDA Device · Class I · 2021-01-20 · Boston Scientific - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radiois…
FDA Device · Class II · 2021-01-20 · Ge Healthcare - Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 087147299…
FDA Device · Class I · 2021-01-20 · Boston Scientific - Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
FDA Device · Class II · 2021-01-20 · Siemens Medical Solutions Usa - Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - All EPIQ and Affiniti Ultrasound systems
FDA Device · Class II · 2021-01-20 · Philips Ultrasound - EXOGEN Ultrasound Coupling Gel
FDA Device · Class II · 2021-01-20 · Bioventus - Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for dete…
FDA Device · Class II · 2021-01-20 · Philips North America - Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intend…
FDA Device · Class II · 2021-01-20 · Ge Healthcare - Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens
FDA Device · Class II · 2021-01-20 · Siemens Healthcare Diagnostics
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)