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.
- da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
FDA Device · Class II · 2026-01-21 · Intuitive Surgical - Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
FDA Device · Class II · 2026-01-21 · Medicrea International - Product Name: Allura Xper FD10C
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - SMV BodyTrack, System, Tomography, Computed, Emission
FDA Device · Class II · 2026-01-21 · Ge Medical Systems Israel Functional Imaging - SMV DSX New Line, System, Tomography, Computed, Emission
FDA Device · Class II · 2026-01-21 · Ge Medical Systems Israel Functional Imaging - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline K…
FDA Device · Class II · 2026-01-21 · Medline Industries - Allura Xper FD20
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - Allura Xper FD20/20
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
FDA Device · Class II · 2026-01-21 · Hangzhou Bever Medical Devices - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B
FDA Device · Class II · 2026-01-21 · Medline Industries - Brand Name: PALACOS Product Name: PALACOS MV+G pro 40
FDA Device · Class II · 2026-01-21 · Heraeus Medical Dental Division - Allura Xper FD20 Biplane
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
FDA Device · Class II · 2026-01-21 · Elekta - Allura Xper FD10
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - SMV DSI, System, Tomography, Computed, Emission
FDA Device · Class II · 2026-01-21 · Ge Medical Systems Israel Functional Imaging - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU D…
FDA Device · Class II · 2026-01-21 · Medline Industries - FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li…
FDA Device · Class I · 2026-01-21 · Abbott Diabetes Care - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit S…
FDA Device · Class II · 2026-01-21 · Medline Industries - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU…
FDA Device · Class II · 2026-01-21 · Medline Industries - ThinPrep¿ CytoLyt¿ Solution
FDA Device · Class II · 2026-01-21 · Hologic - Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combi…
FDA Device · Class II · 2026-01-21 · C Rad Positioning Ab - Brand Name: PALACOS Product Name: PALACOS R+G pro 40
FDA Device · Class II · 2026-01-21 · Heraeus Medical Dental Division - Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T
FDA Device · Class II · 2026-01-21 · Medline Industries - Allura Xper FD10
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Cont…
FDA Device · Class I · 2026-01-21 · Abbott Diabetes Care - The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy
FDA Device · Class II · 2026-01-21 · Instrumentation Laboratory - Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
FDA Device · Class II · 2026-01-21 · Icu Medical - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS, Medline kit SKU DYKM1…
FDA Device · Class II · 2026-01-21 · Medline Industries - Brand Name: PALACOS Product Name: PALACOS MV pro 40
FDA Device · Class II · 2026-01-21 · Heraeus Medical Dental Division - Allura Xper FD20/10
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - Plum Duo Infusion System, List Number 40002-04-01
FDA Device · Class II · 2026-01-21 · Icu Medical - Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
FDA Device · Class II · 2026-01-21 · Medicrea International - FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li…
FDA Device · Class I · 2026-01-21 · Abbott Diabetes Care - Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System
FDA Device · Class II · 2026-01-21 · Mobius Imaging - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, Medline kit SKU DYNJ389…
FDA Device · Class II · 2026-01-21 · Medline Industries - FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li…
FDA Device · Class I · 2026-01-21 · Abbott Diabetes Care - Allura Xper FD20 Biplane
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
FDA Device · Class II · 2026-01-21 · Canon Medical System Usa - Allura Xper FD10/10
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - Allura Xper FD10/10
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - Asserachrom HPIA. Model/Catalog Number: 00615
FDA Device · Class II · 2026-01-21 · Diagnostica Stago - MAXXUS, System, Tomography, Computed, Emission
FDA Device · Class II · 2026-01-21 · Ge Medical Systems Israel Functional Imaging - Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit S…
FDA Device · Class II · 2026-01-21 · Medline Industries - Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System
FDA Device · Class II · 2026-01-21 · Mobius Imaging - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984…
FDA Device · Class II · 2026-01-21 · Medline Industries - Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B
FDA Device · Class II · 2026-01-21 · Medline Industries - Philips Azurion Systems with software versions R2.1.10 and R2.2.10
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
FDA Device · Class II · 2026-01-21 · Medline Industries - Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L
FDA Device · Class II · 2026-01-21 · Medline Industries - MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
FDA Device · Class II · 2026-01-21 · Repligen - Allura Xper FD20 OR Table
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210
FDA Device · Class II · 2026-01-21 · Boston Scientific - Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M
FDA Device · Class II · 2026-01-21 · Medline Industries - VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
FDA Device · Class II · 2026-01-21 · Canon Medical System Usa - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B
FDA Device · Class II · 2026-01-21 · Medline Industries - Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005
FDA Device · Class II · 2026-01-21 · Fresenius Kabi Usa - Allura Xper FD20
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - Portex Spinal Tray, Item No. A3729-24 A3595
FDA Device · Class II · 2026-01-21 · Icu Medical - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS203…
FDA Device · Class II · 2026-01-21 · Medline Industries - Philips Incisive CT
FDA Device · Class II · 2026-01-14 · Philips Healthcare Suzhou - Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU
FDA Device · Class II · 2026-01-14 · Abiomed - Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
FDA Device · Class I · 2026-01-14 · Avid Medical - Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
FDA Device · Class II · 2026-01-14 · Securitas Healthcare - 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 (2,388) · 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)