FDA Device · 2026
FDA Device recalls in 2026
RecallRadar indexes 2,388 FDA Device recall notices published in 2026. By classification: 287 Class I, 2,066 Class II, 35 Class III.
- Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104
FDA Device · Class II · 2026-02-25 · Medline Industries - Olympus High Flow Insufflation Unit
FDA Device · Class I · 2026-02-25 · Olympus - Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
FDA Device · Class II · 2026-02-25 · Olympus - Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
FDA Device · Class II · 2026-02-25 · Olympus - Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O
FDA Device · Class II · 2026-02-25 · Medline Industries - Olympus High Flow Insufflation Unit
FDA Device · Class I · 2026-02-25 · Olympus - Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
FDA Device · Class II · 2026-02-25 · Olympus - Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
FDA Device · Class II · 2026-02-25 · Olympus - Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499
FDA Device · Class II · 2026-02-25 · Medline Industries - Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
FDA Device · Class II · 2026-02-25 · Olympus - Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I
FDA Device · Class II · 2026-02-25 · Medline Industries - MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Device · Class II · 2026-02-25 · Auris Health - Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery
FDA Device · Class II · 2026-02-25 · Intuitive Surgical - Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I
FDA Device · Class II · 2026-02-25 · Medline Industries - Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
FDA Device · Class II · 2026-02-25 · Olympus - Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
FDA Device · Class II · 2026-02-25 · Medline Industries - MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pac…
FDA Device · Class II · 2026-02-25 · Stryker - Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185
FDA Device · Class II · 2026-02-25 · Medline Industries - MediHoney Gel with Active Leptospermum Honey
FDA Device · Class II · 2026-02-25 · Integra Lifesciences Neurosciences - Medica Capillary Tubes
FDA Device · Class II · 2026-02-25 · Medica - Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001
FDA Device · Class II · 2026-02-25 · Medline Industries - Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233
FDA Device · Class II · 2026-02-18 · Philips Medical Systems Nederland B V - Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only)
FDA Device · Class II · 2026-02-18 · Philips Medical Systems Nederland B V - Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710
FDA Device · Class II · 2026-02-18 · Medline Industries - Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA
FDA Device · Class II · 2026-02-18 · Laerdal Medical - Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
FDA Device · Class III · 2026-02-18 · Surepulse Medical - Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell G…
FDA Device · Class II · 2026-02-18 · Elekta - Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
FDA Device · Class II · 2026-02-18 · Medline Industries - Spectral CT 7500 on Rails
FDA Device · Class II · 2026-02-18 · Philips North America - Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229
FDA Device · Class II · 2026-02-18 · Philips Medical Systems Nederland B V - Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
FDA Device · Class I · 2026-02-18 · Medline Industries - IQon Spectral CT
FDA Device · Class II · 2026-02-18 · Philips North America - Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C
FDA Device · Class II · 2026-02-18 · Medline Industries - Azurion 5 M12 System Model Numbers: (1)722227, (2)722231
FDA Device · Class II · 2026-02-18 · Philips Medical Systems Nederland B V - Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH
FDA Device · Class I · 2026-02-18 · Medline Industries - Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Lek…
FDA Device · Class II · 2026-02-18 · Elekta - Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
FDA Device · Class II · 2026-02-18 · Medline Industries - ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471
FDA Device · Class II · 2026-02-18 · Alphatec Spine - Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
FDA Device · Class II · 2026-02-18 · Medline Industries - Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
FDA Device · Class II · 2026-02-18 · Medline Industries - Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 40158…
FDA Device · Class I · 2026-02-18 · Medline Industries - Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
FDA Device · Class II · 2026-02-18 · Medline Industries - Brevera Breast Biopsy System Disposable 9 Gauge Needle
FDA Device · Class II · 2026-02-18 · Hologic - da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
FDA Device · Class II · 2026-02-18 · Intuitive Surgical - Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
FDA Device · Class III · 2026-02-18 · Surepulse Medical - Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576
FDA Device · Class II · 2026-02-18 · Medline Industries - ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179
FDA Device · Class II · 2026-02-18 · Alphatec Spine - Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only)
FDA Device · Class II · 2026-02-18 · Philips Medical Systems Nederland B V - Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
FDA Device · Class III · 2026-02-18 · Surepulse Medical - Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH
FDA Device · Class I · 2026-02-18 · Medline Industries - Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
FDA Device · Class II · 2026-02-18 · Medline Industries - Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
FDA Device · Class II · 2026-02-18 · Medline Industries - Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
FDA Device · Class II · 2026-02-18 · Medline Industries - Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only)
FDA Device · Class II · 2026-02-18 · Philips Medical Systems Nederland B V - Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter U…
FDA Device · Class I · 2026-02-18 · Medline Industries - Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
FDA Device · Class III · 2026-02-18 · Surepulse Medical - Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235
FDA Device · Class II · 2026-02-18 · Philips Medical Systems Nederland B V - Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236
FDA Device · Class II · 2026-02-18 · Philips Medical Systems Nederland B V - 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
Other years
2026 (2,388) · 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)