FDA Device · 2025
FDA Device recalls in 2025
RecallRadar indexes 2,908 FDA Device recall notices published in 2025. By classification: 380 Class I, 2,433 Class II, 95 Class III.
- NOxBOXi Nitric Oxide Delivery System
FDA Device · Class I · 2025-10-15 · Noxbox - Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7…
FDA Device · Class II · 2025-10-15 · Fresenius Medical Care Holdings - PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERI…
FDA Device · Class II · 2025-10-15 · B Braun Medical - Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Sp…
FDA Device · Class II · 2025-10-15 · B Braun Medical - PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PE…
FDA Device · Class II · 2025-10-15 · B Braun Medical - PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip…
FDA Device · Class II · 2025-10-15 · B Braun Medical - NOxBOXi Nitric Oxide Delivery System
FDA Device · Class I · 2025-10-15 · Noxbox - Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm)…
FDA Device · Class II · 2025-10-15 · B Braun Medical - NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGlide Nasal Feeding Tube is a feeding tube…
FDA Device · Class II · 2025-10-15 · Applied Medical Technology - Design Options, PERIFIX FX Epidural Anesthesia Tray
FDA Device · Class II · 2025-10-15 · B Braun Medical - NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tube is a feeding tube…
FDA Device · Class II · 2025-10-15 · Applied Medical Technology - Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. I…
FDA Device · Class I · 2025-10-15 · Abiomed - PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX…
FDA Device · Class II · 2025-10-15 · B Braun Medical - PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwo…
FDA Device · Class II · 2025-10-15 · B Braun Medical - PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed ti…
FDA Device · Class II · 2025-10-15 · B Braun Medical - BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-S…
FDA Device · Class I · 2025-10-15 · Carefusion 303 - NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube…
FDA Device · Class II · 2025-10-15 · Applied Medical Technology - FlexLab X (FXX) System
FDA Device · Class II · 2025-10-15 · Inpeco - ClariTEE Miniaturized TEE probe
FDA Device · Class II · 2025-10-15 · Imacor - SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only
FDA Device · Class II · 2025-10-15 · Beckman Coulter - AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
FDA Device · Class II · 2025-10-15 · Ge Medical Systems Scs - Design Options, Pain Management Tray
FDA Device · Class II · 2025-10-15 · B Braun Medical - NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tube is a feeding tube…
FDA Device · Class II · 2025-10-15 · Applied Medical Technology - ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.…
FDA Device · Class II · 2025-10-15 · B Braun Medical - PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip…
FDA Device · Class II · 2025-10-15 · B Braun Medical - FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
FDA Device · Class II · 2025-10-15 · Fujifilm Healthcare Americas - NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter
FDA Device · Class II · 2025-10-08 · Northeast Scientific - NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter
FDA Device · Class II · 2025-10-08 · Northeast Scientific - BIOGRAPH One (DE). Model Number: 11689172
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter
FDA Device · Class II · 2025-10-08 · Northeast Scientific - MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - MAGNETOM Connectom.X. Model Number: 11371480
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - Getinge 88-Series Washer- Disinfector
FDA Device · Class II · 2025-10-08 · Getinge Disinfection Ab - AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R
FDA Device · Class II · 2025-10-08 · Aesculap Ag - VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n
FDA Device · Class II · 2025-10-08 · Biomerieux - Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic s…
FDA Device · Class I · 2025-10-08 · Medline Industries - MAGNETOM Verio Dot
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220)
FDA Device · Class II · 2025-10-08 · Medicalcommunications - Allura Xper FD10C
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K17359…
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - MAGNETOM Skyra Fit BioMatrix
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - Allura Xper FD20/15
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352
FDA Device · Class II · 2025-10-08 · Beckman Coulter - Allura Xper FD10 OR Table
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442
FDA Device · Class II · 2025-10-08 · Howmedica Osteonics - Allura Xper FD20 Biplane
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and phys…
FDA Device · Class I · 2025-10-08 · Medline Industries - MAGNETOM Verio Dot Upgrade
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - MAGNETOM Prisma
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter
FDA Device · Class II · 2025-10-08 · Northeast Scientific - Allura Xper FD20/10
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - Allura Xper FD10
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - Allura Xper FD20 OR Table
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter
FDA Device · Class II · 2025-10-08 · Northeast Scientific - Allura Xper FD20/20
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - Biograph mMR. Model Number: 10433372
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - Allura Xper FD20/20 OR Table
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - Medtronic, Simplera Sensor, REF: MMT-5100JD1
FDA Device · Class II · 2025-10-08 · Medtronic Minimed - Change Healthcare Radiology Solutions software version 14.2.2
FDA Device · Class II · 2025-10-08 · Change Healthcare Canada - Cardio Vascular-Allura Centron
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P
FDA Device · Class I · 2025-10-08 · Medline Industries - MAGNETOM Vida Fit
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures
FDA Device · Class I · 2025-10-08 · Medline Industries - NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter
FDA Device · Class II · 2025-10-08 · Northeast Scientific - Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O
FDA Device · Class I · 2025-10-08 · Medline Industries - MAGNETOM Spectra as the following: 1. MAGNETOM Spectra
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550
FDA Device · Class II · 2025-10-08 · North American Rescue - Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures
FDA Device · Class I · 2025-10-08 · Medline Industries - Allura Xper FD10/10
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is…
FDA Device · Class I · 2025-10-08 · Draeger - Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 40165…
FDA Device · Class I · 2025-10-08 · Medline Industries - Allura Xper FD20 Biplane OR Table
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - ZAP-X Radiosurgery System, Model: 300150
FDA Device · Class II · 2025-10-08 · Zap Surgical Systems - Allura Xper FD20/15 OR Table
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - Allura Xper CV20
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
FDA Device · Class II · 2025-10-08 · Schiller Ag - Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation…
FDA Device · Class II · 2025-10-08 · Bard Peripheral Vascular - Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) A…
FDA Device · Class II · 2025-10-08 · Lemaitre Vascular - MAGNETOM Lumina (DE). Model Number: 11344916
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
FDA Device · Class I · 2025-10-08 · Medline Industries - Allura Xper FD20
FDA Device · Class II · 2025-10-08 · Philips Medical Systems Nederland B V - IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N
FDA Device · Class II · 2025-10-08 · S I N Implant System Ltda - MAGNETOM Verio
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - MAGNETOM Skyra fit
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040…
FDA Device · Class II · 2025-10-08 · W L Gore And Associates - NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter
FDA Device · Class II · 2025-10-08 · Northeast Scientific - AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R
FDA Device · Class II · 2025-10-08 · Aesculap Ag - MAGNETOM Cima.X (DE). Model Number: 11647158
FDA Device · Class I · 2025-10-08 · Siemens Medical Solutions Usa - NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter
FDA Device · Class II · 2025-10-08 · Northeast Scientific - Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan…
FDA Device · Class I · 2025-10-08 · Draeger - Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Sofmed Breathables, (stenfilcon A) contact lens
FDA Device · Class II · 2025-10-01 · Coopervision - Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243…
FDA Device · Class II · 2025-10-01 · Philips North America - FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with…
FDA Device · Class II · 2025-10-01 · Biofire Defense - Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311
FDA Device · Class II · 2025-10-01 · Philips North America - Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246.…
FDA Device · Class II · 2025-10-01 · Philips North America - Allura Xper FD20/15 OR Table
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Allura Xper FD20/20 OR Table
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Voyant 1-Day Premium Toric, (stenfilcon A) contact lens
FDA Device · Class II · 2025-10-01 · Coopervision - Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324
FDA Device · Class II · 2025-10-01 · Philips North America
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)