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.
- The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement
FDA Device · Class II · 2026-01-14 · Vision Rt - LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
FDA Device · Class II · 2026-01-14 · Siemens Medical Solutions Usa - The Pressio 2 ICP Monitoring System, Model Number PSO-4000
FDA Device · Class II · 2026-01-14 · Sophysa - Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288
FDA Device · Class II · 2026-01-14 · Beckman Coulter - Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
FDA Device · Class II · 2026-01-14 · Applied Medical Resources - Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY
FDA Device · Class II · 2026-01-14 · Medline Industries - Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
FDA Device · Class II · 2026-01-14 · Securitas Healthcare - Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-20…
FDA Device · Class II · 2026-01-14 · Remote Diagnostic Technologies - Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
FDA Device · Class II · 2026-01-14 · Meridian Bioscience - Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-6…
FDA Device · Class II · 2026-01-14 · Imris Imaging - The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminesce…
FDA Device · Class II · 2026-01-14 · Roche Diagnostics Operations - Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260
FDA Device · Class II · 2026-01-14 · Beckman Coulter - Codman CereLink ICP Sensor Basic Kit
FDA Device · Class II · 2026-01-14 · Integra Lifesciences Neurosciences - Codman Microsensor Basic Kit
FDA Device · Class II · 2026-01-14 · Integra Lifesciences Neurosciences - BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01…
FDA Device · Class II · 2026-01-14 · Carefusion 303 - Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor
FDA Device · Class II · 2026-01-14 · Philips North America - Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17
FDA Device · Class I · 2026-01-14 · Avid Medical - Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15
FDA Device · Class I · 2026-01-14 · Avid Medical - Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25
FDA Device · Class II · 2026-01-07 · Vortex Surgical - Material Processing Laser Products
FDA Device · Class II · 2026-01-07 · Shenzhen Atomstack Technologies - BVI Leos Laser and Endoscopy System
FDA Device · Class II · 2026-01-07 · Beaver Visitec International - Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795…
FDA Device · Class II · 2026-01-07 · Philips Ultrasound - Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3…
FDA Device · Class II · 2026-01-07 · Ferndale Laboratories - Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Pro…
FDA Device · Class II · 2026-01-07 · Sheathing Technologies
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)