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.
- Titan Touch Pump, Catalog Numbers 5177502400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
FDA Device · Class II · 2023-04-19 · Philips North America - Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20…
FDA Device · Class II · 2023-04-19 · Covidien - Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
FDA Device · Class II · 2023-04-19 · Merit Medical Systems - Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
FDA Device · Class II · 2023-04-19 · Covidien - DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Device · Class II · 2023-04-19 · Philips North America - stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Device · Class II · 2023-04-19 · Howmedica Osteonics - Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
FDA Device · Class II · 2023-04-19 · Philips North America - Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
FDA Device · Class I · 2023-04-12 · Abbott Diabetes Care - Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa - CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems - FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
FDA Device · Class I · 2023-04-12 · Abbott Diabetes Care - Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15…
FDA Device · Class I · 2023-04-12 · Philips Respironics - Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster - Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
FDA Device · Class I · 2023-04-12 · Philips Respironics - Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa - Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa - Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for use in…
FDA Device · Class II · 2023-04-12 · Stryker - Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in…
FDA Device · Class II · 2023-04-12 · Stryker - Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in…
FDA Device · Class II · 2023-04-12 · Stryker - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster - Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa - Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa - VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
FDA Device · Class II · 2023-04-12 · Maquet Cardiovascular - Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa - Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4
FDA Device · Class II · 2023-04-12 · Abbott Molecular - Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in…
FDA Device · Class II · 2023-04-12 · Stryker - Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU21…
FDA Device · Class I · 2023-04-12 · Philips Respironics - Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa - VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
FDA Device · Class II · 2023-04-12 · Maquet Cardiovascular - FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
FDA Device · Class I · 2023-04-12 · Abbott Diabetes Care - Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa - Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in…
FDA Device · Class II · 2023-04-12 · Stryker - Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
FDA Device · Class II · 2023-04-12 · Coopersurgical - VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
FDA Device · Class II · 2023-04-12 · Maquet Cardiovascular - Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa - Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and…
FDA Device · Class II · 2023-04-12 · Moberg Research - CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems - Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa - Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the a…
FDA Device · Class II · 2023-04-12 · Remote Diagnostic Technologies - CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems - Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
FDA Device · Class II · 2023-04-12 · Stryker - Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14
FDA Device · Class I · 2023-04-12 · Philips Respironics - Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa - PCRopsis Support: a) 1 mL, REF 787001
FDA Device · Class II · 2023-04-05 · Entopsis - SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
FDA Device · Class II · 2023-04-05 · Limacorporate S P A - Cirq Arm System 2.0
FDA Device · Class II · 2023-04-05 · Brainlab Ag - GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertain…
FDA Device · Class II · 2023-04-05 · Gaga Pro Lighting Equipment - ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysi…
FDA Device · Class II · 2023-04-05 · Instrumentation Laboratory - PCRopsis BCSNano (1mL), REF 2276001
FDA Device · Class II · 2023-04-05 · Entopsis - ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis tes…
FDA Device · Class II · 2023-04-05 · Instrumentation Laboratory - ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing
FDA Device · Class II · 2023-04-05 · Instrumentation Laboratory - Automated Peritoneal Dialysis System
FDA Device · Class II · 2023-04-05 · Baxter Healthcare - Atrium Pneumostat Chest Drain Valve, Part Number 16100
FDA Device · Class II · 2023-04-05 · Atrium Medical - ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing
FDA Device · Class II · 2023-04-05 · Instrumentation Laboratory - PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001
FDA Device · Class II · 2023-04-05 · Entopsis - Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blu…
FDA Device · Class II · 2023-04-05 · Stryker Sustainability Solutions - Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR…
FDA Device · Class II · 2023-04-05 · Alcon Research - PCRopsis Activator: a) 1.5mL, REF 228001
FDA Device · Class II · 2023-04-05 · Entopsis - MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, C…
FDA Device · Class II · 2023-04-05 · Quidel - CRP Immunoturbidimetric reagent
FDA Device · Class II · 2023-04-05 · Randox Laboratories - DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
FDA Device · Class II · 2023-04-05 · Defibtech - PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000
FDA Device · Class II · 2023-04-05 · Entopsis - Express Mini 500 Dry Seal Chest Drain, Part Number 16400
FDA Device · Class II · 2023-04-05 · Atrium Medical - CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty
FDA Device · Class II · 2023-04-05 · Zimmer - PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001
FDA Device · Class II · 2023-04-05 · Entopsis - Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
FDA Device · Class II · 2023-04-05 · Preat - Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50
FDA Device · Class II · 2023-04-05 · Iradimed - COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicate…
FDA Device · Class II · 2023-04-05 · Covidien - da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
FDA Device · Class II · 2023-04-05 · Intuitive Surgical - Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Cath…
FDA Device · Class II · 2023-04-05 · Elekta Instrument Ab - ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system
FDA Device · Class II · 2023-04-05 · Siemens Medical Solutions Usa - Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
FDA Device · Class II · 2023-04-05 · Fujifilm Irvine Scientific - PCRopsis Reagent Buccal, IVD, REF 282001
FDA Device · Class II · 2023-04-05 · Entopsis - Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
FDA Device · Class II · 2023-03-29 · Datascope - Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
FDA Device · Class II · 2023-03-29 · Deroyal Industries - BD Pyxis Anesthesia ES System (PAS ES), REF: 327
FDA Device · Class II · 2023-03-29 · Carefusion 303 - Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
FDA Device · Class II · 2023-03-29 · Vapotherm - Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
FDA Device · Class II · 2023-03-29 · Coopervision - Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturatio…
FDA Device · Class II · 2023-03-29 · Withings - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-…
FDA Device · Class II · 2023-03-29 · Datascope - Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.…
FDA Device · Class II · 2023-03-29 · Raysearch Laboratories Ab - Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Device · Class II · 2023-03-29 · Datascope - Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
FDA Device · Class II · 2023-03-29 · Datascope - G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
FDA Device · Class II · 2023-03-29 · Biomet - BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering i…
FDA Device · Class II · 2023-03-22 · Becton Dickinson And - Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK
FDA Device · Class II · 2023-03-22 · Bard Peripheral Vascular - Amicus Exchange Kit Therapeutics
FDA Device · Class II · 2023-03-22 · Fenwal - In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
FDA Device · Class II · 2023-03-22 · Biofire Diagnostics - Plato 17 Microcatheter: Straight Tip, PL17-160-000
FDA Device · Class II · 2023-03-22 · Scientia Vascular
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)