FDA Device · 2026
FDA Device recalls in 2026
RecallRadar indexes 2,024 FDA Device recall notices published in 2026. By classification: 254 Class I, 1,736 Class II, 34 Class III.
- Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
FDA Device · Class II · 2026-02-18 · Steris - Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Cat…
FDA Device · Class I · 2026-02-18 · Medline Industries - Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH
FDA Device · Class I · 2026-02-18 · Medline Industries - Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
FDA Device · Class II · 2026-02-18 · Medline Industries - WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
FDA Device · Class III · 2026-02-18 · Straumann Usa - 1) UNIVERSAL KIT, Kit SKU DT22010B
FDA Device · Class II · 2026-02-18 · Medline Industries - Spectral CT
FDA Device · Class II · 2026-02-18 · Philips North America - Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01
FDA Device · Class II · 2026-02-18 · Avid Medical - Brilliance iCT
FDA Device · Class II · 2026-02-18 · Philips North America - Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
FDA Device · Class III · 2026-02-18 · Surepulse Medical - 25GA Subretinal Injection Cannula VS0220.25
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730
FDA Device · Class II · 2026-02-11 · Olympus - Focalyx Fusion
FDA Device · Class II · 2026-02-11 · Focalyx Technologies - Vivoo Protein Test
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been de…
FDA Device · Class II · 2026-02-11 · Olympus - HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm
FDA Device · Class I · 2026-02-11 · Boston Scientific - The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - PRISMAFLEX M150 SET, Product Code 109990
FDA Device · Class II · 2026-02-11 · Vantive Us Healthcare - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730
FDA Device · Class II · 2026-02-11 · Olympus - PRISMAFLEX ST100 SET US, Product Code 107636US
FDA Device · Class II · 2026-02-11 · Vantive Us Healthcare - Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipuls…
FDA Device · Class II · 2026-02-11 · Fujirebio Diagnostics - Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable P…
FDA Device · Class II · 2026-02-11 · Fujirebio Diagnostics - AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm
FDA Device · Class I · 2026-02-11 · Boston Scientific - NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
FDA Device · Class II · 2026-02-11 · Siemens Medical Solutions Usa - PRISMAFLEX HF1000 SET, Product Code 107140
FDA Device · Class II · 2026-02-11 · Vantive Us Healthcare - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730
FDA Device · Class II · 2026-02-11 · Olympus - LotFancy Urinary Tract Infection Urine (UTI) Test Strips
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320
FDA Device · Class II · 2026-02-11 · Olympus - Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exend…
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been desi…
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been de…
FDA Device · Class II · 2026-02-11 · Olympus - PRIMSAFLEX M100 SET, Product Code 106697
FDA Device · Class II · 2026-02-11 · Vantive Us Healthcare - CellMek SPS Sample Preparation System, REF: C44603, with software
FDA Device · Class II · 2026-02-11 · Beckman Coulter - Vivoo Sodium Test
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lum…
FDA Device · Class II · 2026-02-11 · Fujirebio Diagnostics - Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Menopause Test Cassette (Urine)
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been de…
FDA Device · Class II · 2026-02-11 · Olympus - PRISMAFLEX HF1000 SET, Product Code 107142
FDA Device · Class II · 2026-02-11 · Vantive Us Healthcare - Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Force…
FDA Device · Class II · 2026-02-11 · Vortex Surgical - MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use…
FDA Device · Class II · 2026-02-11 · Medtronic Minimed - Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product De…
FDA Device · Class II · 2026-02-11 · Fujirebio Diagnostics - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipul…
FDA Device · Class II · 2026-02-11 · Fujirebio Diagnostics - *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm
FDA Device · Class I · 2026-02-11 · Boston Scientific - OXIRIS SET, Product Code 112016
FDA Device · Class II · 2026-02-11 · Vantive Us Healthcare - Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been de…
FDA Device · Class II · 2026-02-11 · Olympus - Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000
FDA Device · Class II · 2026-02-11 · Intuitive Surgical - NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
FDA Device · Class II · 2026-02-11 · Siemens Medical Solutions Usa - Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Descrip…
FDA Device · Class II · 2026-02-11 · Fujirebio Diagnostics - PRISMAFLEX ST150 SET US, Product Code 107640US
FDA Device · Class II · 2026-02-11 · Vantive Us Healthcare - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720
FDA Device · Class II · 2026-02-11 · Olympus - TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
FDA Device · Class II · 2026-02-11 · Tornier - Bubble Sensor for 3/8" x 3/32" tubing
FDA Device · Class II · 2026-02-11 · Maquet Cardiopulmonary - Vortex Surgical 25GA Backflush, VS0270.25
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been de…
FDA Device · Class II · 2026-02-11 · Olympus - Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L P…
FDA Device · Class II · 2026-02-11 · Olympus - Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320…
FDA Device · Class II · 2026-02-11 · Olympus - COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-fr…
FDA Device · Class II · 2026-02-11 · Beckman Coulter - Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
FDA Device · Class II · 2026-02-11 · Vortex Surgical - LH One Step Ovulation Test Device (Urine)
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01…
FDA Device · Class II · 2026-02-11 · Biomerieux - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720
FDA Device · Class II · 2026-02-11 · Olympus - Vivoo pH Test
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been desi…
FDA Device · Class II · 2026-02-11 · Olympus - Male Fertility Sperm Test for Home Use (Cassette)
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Descrip…
FDA Device · Class II · 2026-02-11 · Fujirebio Diagnostics - Tecfen Retractable Membrane Polisher, QTPR1267-23
FDA Device · Class II · 2026-02-11 · Vortex Surgical - SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
FDA Device · Class II · 2026-02-11 · Siemens Medical Solutions Usa - Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments…
FDA Device · Class II · 2026-02-11 · Olympus - FDR Visionary Suite
FDA Device · Class II · 2026-02-11 · Fujifilm Healthcare Americas - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330
FDA Device · Class II · 2026-02-11 · Olympus - EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
FDA Device · Class II · 2026-02-11 · Encore Medical - Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402…
FDA Device · Class II · 2026-02-11 · Etac A S - Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
FDA Device · Class II · 2026-02-11 · Wilson Cook Medical - Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Vortex Surgical I2 Injection Kit, VS0500
FDA Device · Class II · 2026-02-11 · Vortex Surgical - AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm
FDA Device · Class I · 2026-02-11 · Boston Scientific - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been de…
FDA Device · Class II · 2026-02-11 · Olympus - NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
FDA Device · Class II · 2026-02-11 · Siemens Medical Solutions Usa - EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H
FDA Device · Class II · 2026-02-11 · Encore Medical - Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat…
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M1500…
FDA Device · Class II · 2026-02-11 · Etac A S - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been de…
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been desi…
FDA Device · Class II · 2026-02-11 · Olympus - Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-…
FDA Device · Class II · 2026-02-11 · Olympus - Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been desi…
FDA Device · Class II · 2026-02-11 · Olympus - PRISMAFLEX TPE2000 SET, Product Code 114093
FDA Device · Class II · 2026-02-11 · Vantive Us Healthcare - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330
FDA Device · Class II · 2026-02-11 · Olympus - *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm
FDA Device · Class I · 2026-02-11 · Boston Scientific - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been desi…
FDA Device · Class II · 2026-02-11 · Olympus
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)