FDA Device · 2023
FDA Device recalls in 2023
RecallRadar indexes 2,477 FDA Device recall notices published in 2023. By classification: 495 Class I, 1,959 Class II, 23 Class III.
- ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Metal Tray, 178 x 135 x 37 mm, REF: 11580A
FDA Device · Class II · 2023-06-28 · Karl Storz Endoscopy - ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D,…
FDA Device · Class II · 2023-06-28 · Draeger Medical Systems - ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitr…
FDA Device · Class II · 2023-06-28 · Helena Laboratories - CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
FDA Device · Class II · 2023-06-28 · Illumina - Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
FDA Device · Class II · 2023-06-28 · Masimo - CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049
FDA Device · Class II · 2023-06-28 · Wilson Cook Medical - ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
FDA Device · Class II · 2023-06-28 · Masimo - ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Total Knee Pack, REF CETJ130, medical convenience kits
FDA Device · Class III · 2023-06-21 · American Contract Systems - bellavista 1000 Ventilator, Catalogue Number 301.100.030
FDA Device · Class II · 2023-06-21 · Vyaire Medical - Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - bellavista 1000e Ventilator, Catalogue Number 301.100.130
FDA Device · Class II · 2023-06-21 · Vyaire Medical - Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
FDA Device · Class II · 2023-06-21 · Remote Diagnostic Technologies - Icelock 125 Ratchet, REF: L-125000
FDA Device · Class II · 2023-06-21 · Ossur H F - Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
FDA Device · Class II · 2023-06-21 · Galt Medical - Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
FDA Device · Class II · 2023-06-21 · Howmedica Osteonics - Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - p-Chip Wand Reader
FDA Device · Class II · 2023-06-21 · P Chip - Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (…
FDA Device · Class II · 2023-06-21 · Galt Medical - Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System…
FDA Device · Class II · 2023-06-21 · Boston Scientific Neuromodulation - 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
FDA Device · Class II · 2023-06-21 · New Standard Device - SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area
FDA Device · Class II · 2023-06-21 · Lumiradx - Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - Medicine Dropper, Product Code K508
FDA Device · Class II · 2023-06-21 · Apothecary Products - NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
FDA Device · Class I · 2023-06-21 · Noxbox - Eye and Ear Dropper, Product Code 67082
FDA Device · Class II · 2023-06-21 · Apothecary Products - Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
FDA Device · Class III · 2023-06-21 · Datascope - Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
FDA Device · Class II · 2023-06-21 · Merit Medical Systems - Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil
FDA Device · Class II · 2023-06-14 · Elekta - AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
FDA Device · Class II · 2023-06-14 · Avanos Medical - Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack
FDA Device · Class II · 2023-06-14 · Cardinal Health 200 - ambIT Cassette Filter Male Luer, Product Code: 220266
FDA Device · Class II · 2023-06-14 · Avanos Medical - Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G,…
FDA Device · Class II · 2023-06-14 · C R Bard - StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
FDA Device · Class I · 2023-06-14 · Medtronic Navigation - DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobiliz…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson - Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center
FDA Device · Class II · 2023-06-14 · Deroyal Industries - RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precisio…
FDA Device · Class III · 2023-06-14 · Mechatronics Usa - DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobiliza…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson - AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
FDA Device · Class II · 2023-06-14 · Avanos Medical - Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14…
FDA Device · Class I · 2023-06-14 · Philips Respironics - DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilizat…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson - Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, K…
FDA Device · Class I · 2023-06-14 · Philips Respironics - HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 7…
FDA Device · Class II · 2023-06-14 · C R Bard - Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital
FDA Device · Class II · 2023-06-14 · Deroyal Industries - BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635
FDA Device · Class II · 2023-06-14 · Young Dental Manufacturing I - Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
FDA Device · Class II · 2023-06-14 · C R Bard - SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
FDA Device · Class II · 2023-06-14 · Avanos Medical - Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X…
FDA Device · Class I · 2023-06-14 · Philips Respironics - BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitat…
FDA Device · Class II · 2023-06-14 · Becton Dickinson And - The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate spec…
FDA Device · Class II · 2023-06-14 · Bioreference Health - Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical…
FDA Device · Class I · 2023-06-14 · Bearcare - DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immob…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson - StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
FDA Device · Class I · 2023-06-14 · Medtronic Navigation - Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f)…
FDA Device · Class II · 2023-06-14 · C R Bard - QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
FDA Device · Class II · 2023-06-14 · Qiagen Sciences - Trilogy Evo Universal Ventilator, Model Number DS2000X11B
FDA Device · Class I · 2023-06-14 · Philips Respironics - DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immo…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson - RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starr…
FDA Device · Class III · 2023-06-14 · Mechatronics Usa - Alinity i Anti-TPO Reagent Kit, List Number 09P3521
FDA Device · Class III · 2023-06-14 · Abbott Ireland - The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extensio…
FDA Device · Class II · 2023-06-14 · Bolton Medical - SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
FDA Device · Class II · 2023-06-14 · Avanos Medical - QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE…
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
FDA Device · Class II · 2023-06-07 · Philips North America - QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa - QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no
FDA Device · Class II · 2023-06-07 · Maquet Medical Systems Usa
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)