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.
- 3M Attest Steam Chemical Integrators, REF 1243B
FDA Device · Class II · 2023-05-24 · 3m Health Care Business - Fisher Wallace Stimulator Models FW-100 and FW-200
FDA Device · Class II · 2023-05-24 · Fisher Wallace Laboratories - VentStar Bag Set (N) 110, MP00383
FDA Device · Class I · 2023-05-24 · Draeger Medical - 3M Attest Steam Chemical Integrators, REF 1243A
FDA Device · Class II · 2023-05-24 · 3m Health Care Business - iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345
FDA Device · Class II · 2023-05-24 · Beckman Coulter - DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
FDA Device · Class II · 2023-05-24 · Beckman Coulter - CombiDiagnost R90 R1.1
FDA Device · Class II · 2023-05-24 · Philips North America - Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numb…
FDA Device · Class I · 2023-05-24 · Abiomed - Ventstar Coax 180, MP03374
FDA Device · Class I · 2023-05-24 · Draeger Medical - greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
FDA Device · Class II · 2023-05-24 · Greiner Bio One North America - Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM
FDA Device · Class II · 2023-05-17 · Bard Peripheral Vascular - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
FDA Device · Class I · 2023-05-17 · Cordis Us - Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139
FDA Device · Class II · 2023-05-17 · Medtronic Sofamor Danek Usa - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
FDA Device · Class I · 2023-05-17 · Cordis Us - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
FDA Device · Class I · 2023-05-17 · Cordis Us - STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
FDA Device · Class II · 2023-05-17 · Diagnostica Stago - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
FDA Device · Class I · 2023-05-17 · Cordis Us - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
FDA Device · Class I · 2023-05-17 · Cordis Us - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
FDA Device · Class I · 2023-05-17 · Cordis Us - TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological…
FDA Device · Class II · 2023-05-17 · Technidata - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
FDA Device · Class I · 2023-05-17 · Cordis Us - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
FDA Device · Class I · 2023-05-17 · Cordis Us - Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-E…
FDA Device · Class I · 2023-05-17 · Cook - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
FDA Device · Class I · 2023-05-17 · Cordis Us - BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
FDA Device · Class II · 2023-05-17 · Bio Rad Laboratories - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
FDA Device · Class I · 2023-05-17 · Cordis Us - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
FDA Device · Class I · 2023-05-17 · Cordis Us - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
FDA Device · Class I · 2023-05-17 · Cordis Us - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
FDA Device · Class I · 2023-05-17 · Cordis Us - STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
FDA Device · Class II · 2023-05-17 · Diagnostica Stago - Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopi…
FDA Device · Class II · 2023-05-17 · Aesculap Implant Systems - ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
FDA Device · Class I · 2023-05-17 · Cordis Us - COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
FDA Device · Class II · 2023-05-17 · Merit Medical Systems - Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-H…
FDA Device · Class I · 2023-05-17 · Cook - M-Close Kit, REF 27-101
FDA Device · Class II · 2023-05-17 · New Wave Endo Surgical - BD Pyxis MedStation ES (Med ES Main), REF: 323
FDA Device · Class II · 2023-05-17 · Carefusion 303 - PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissu…
FDA Device · Class II · 2023-05-17 · Ethicon - STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
FDA Device · Class II · 2023-05-17 · Diagnostica Stago - LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
FDA Device · Class II · 2023-05-10 · Linkbio - VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of ana…
FDA Device · Class II · 2023-05-10 · Ortho Clinical Diagnostics - LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14
FDA Device · Class II · 2023-05-10 · Linkbio - OttLite Rechargeable UVC Disinfecting Wand
FDA Device · Class II · 2023-05-10 · Ottlite Technologies - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60
FDA Device · Class II · 2023-05-10 · Linkbio - injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
FDA Device · Class II · 2023-05-10 · Labories Medical Technologies - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13
FDA Device · Class II · 2023-05-10 · Linkbio - Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248)
FDA Device · Class II · 2023-05-10 · Siemens Healthcare Diagnostics - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12
FDA Device · Class II · 2023-05-10 · Linkbio - Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Apti…
FDA Device · Class II · 2023-05-10 · Inpeco - LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08
FDA Device · Class II · 2023-05-10 · Linkbio - Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical l…
FDA Device · Class II · 2023-05-10 · Steris - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
FDA Device · Class II · 2023-05-10 · Linkbio - ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol R…
FDA Device · Class II · 2023-05-10 · Siemens Healthcare Diagnostics - Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g)…
FDA Device · Class II · 2023-05-10 · Ge Healthcare - LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13
FDA Device · Class II · 2023-05-10 · Linkbio - SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100
FDA Device · Class II · 2023-05-10 · Stryker - WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 1…
FDA Device · Class II · 2023-05-10 · Aso - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01
FDA Device · Class II · 2023-05-10 · Linkbio - Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 208…
FDA Device · Class II · 2023-05-10 · Ge Healthcare - LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06
FDA Device · Class II · 2023-05-10 · Linkbio - Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP…
FDA Device · Class II · 2023-05-10 · Inpeco - Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape…
FDA Device · Class II · 2023-05-10 · Steris - LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08
FDA Device · Class II · 2023-05-10 · Linkbio - Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Ap…
FDA Device · Class II · 2023-05-10 · Inpeco - Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Apt…
FDA Device · Class II · 2023-05-10 · Inpeco - LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
FDA Device · Class II · 2023-05-10 · Linkbio - PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Auto…
FDA Device · Class II · 2023-05-10 · Inpeco - Ultraview SL (UVSL) Command Module, Model 91496
FDA Device · Class II · 2023-05-10 · Spacelabs Healthcare - LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60
FDA Device · Class II · 2023-05-10 · Linkbio - Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluorosco…
FDA Device · Class II · 2023-05-10 · Philips North America - CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery
FDA Device · Class II · 2023-05-10 · Beaver Visitec International - LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13
FDA Device · Class II · 2023-05-10 · Linkbio - ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane di…
FDA Device · Class II · 2023-05-10 · Siemens Medical Solutions Usa
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