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.
- Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, Ra…
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000
FDA Device · Class II · 2026-01-28 · Icu Medical - MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
FDA Device · Class I · 2026-01-28 · Medline Industries - Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal m…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - RayStation/RayPlan
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RaySta…
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - Mazor X robotic guidance system REF: TPL0059
FDA Device · Class II · 2026-01-28 · Mazor Robotics - Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devic…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Rifton Equipment, E-Pacer
FDA Device · Class II · 2026-01-28 · Community Products - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors i…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Descripti…
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - Merit Medical , Custom Manifold Kit REF: K09-13203A
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStati…
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - SQ40S Blood Transfusion Filter
FDA Device · Class II · 2026-01-28 · Gvs Tm - ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
FDA Device · Class II · 2026-01-28 · Icu Medical - Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 0…
FDA Device · Class II · 2026-01-28 · Tyber Medical - MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
FDA Device · Class I · 2026-01-28 · Medline Industries - Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leas…
FDA Device · Class II · 2026-01-28 · Leaseir Technologies Slu - Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
FDA Device · Class II · 2026-01-28 · Icu Medical - Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description…
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Device · Class II · 2026-01-28 · Baxter Healthcare - Patient Information Center iX
FDA Device · Class II · 2026-01-28 · Philips North America - Allwell Inflation Device, for angiographic use REF: IS-30-A
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and M…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14…
FDA Device · Class II · 2026-01-21 · Medtronic - Brand Name: PALACOS Product Name: PALACOS R pro 40
FDA Device · Class II · 2026-01-21 · Heraeus Medical Dental Division - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline…
FDA Device · Class II · 2026-01-21 · Medline Industries - A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200
FDA Device · Class II · 2026-01-21 · Medtronic Neuromodulation - Allura Xper FD10
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016
FDA Device · Class II · 2026-01-21 · Thoratec - Allura Xper FD10/10
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF
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 FD10F
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - 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
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)