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.
- B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to intr…
FDA Device · Class II · 2025-05-14 · Galt Medical - IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x
FDA Device · Class II · 2025-05-14 · Philips Medical Systems Nederland B V - CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127…
FDA Device · Class I · 2025-05-14 · Smiths Medical Asd - B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is i…
FDA Device · Class II · 2025-05-14 · Galt Medical - Atalante X, Powered Exoskeleton
FDA Device · Class II · 2025-05-14 · Wandercraft Sas - Washer Disinfector Aquadis 56
FDA Device · Class II · 2025-05-14 · Getinge Disinfection Ab - CADD-Solis HPCA Ambulatory Infusion Pump
FDA Device · Class I · 2025-05-14 · Smiths Medical Asd - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng…
FDA Device · Class II · 2025-05-14 · Philips North America - Intraocular lens. enVista Monofocal IOL, All models starting with EE
FDA Device · Class I · 2025-05-14 · Bausch And Lomb Surgical - Distal Femoral Augment
FDA Device · Class II · 2025-05-07 · Waldemar Link And Kg Mfg Site - GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
FDA Device · Class II · 2025-05-07 · Medline Industries Northfield - GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/Eng…
FDA Device · Class II · 2025-05-07 · Defibtech - GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
FDA Device · Class II · 2025-05-07 · Medline Industries Northfield - 3.0 Liter Disposable Set (4 sets/case)
FDA Device · Class II · 2025-05-07 · Belmont Instrument - Medline procedure kits, labeled as: HAND, REF DYNJ902002J
FDA Device · Class II · 2025-05-07 · Medline Industries Northfield - Semi-Automated External Defibrillators
FDA Device · Class II · 2025-05-07 · Defibtech - IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170
FDA Device · Class II · 2025-05-07 · Boston Scientific - Straight Inflow/Outflow Patient Line Kit
FDA Device · Class II · 2025-05-07 · Belmont Instrument - GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
FDA Device · Class II · 2025-05-07 · Medline Industries Northfield - IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100
FDA Device · Class II · 2025-05-07 · Boston Scientific - Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma
FDA Device · Class II · 2025-05-07 · Siemens Healthcare Diagnostics - Medline Sterile Water, USP, 100mL, REF RDI30295
FDA Device · Class II · 2025-05-07 · Medline Industries Northfield - GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)…
FDA Device · Class II · 2025-05-07 · Spectrum Medical - GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliabili…
FDA Device · Class II · 2025-05-07 · Trimble Ab - GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Pr…
FDA Device · Class II · 2025-05-07 · Olympus - IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170
FDA Device · Class II · 2025-05-07 · Boston Scientific - GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor…
FDA Device · Class II · 2025-05-07 · Leica Biosystems Melbourne - Automated External Defibrillators, Model DDU-2450
FDA Device · Class II · 2025-05-07 · Defibtech - Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/Eng…
FDA Device · Class II · 2025-05-07 · Defibtech - DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3,…
FDA Device · Class II · 2025-05-07 · Beckman Coulter - GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A
FDA Device · Class II · 2025-05-07 · Medline Industries Northfield - Straight Inflow/Bifurcated Outflow Line Kit
FDA Device · Class II · 2025-05-07 · Belmont Instrument - GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System
FDA Device · Class II · 2025-05-07 · Siemens Healthcare Diagnostics - Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Desc…
FDA Device · Class II · 2025-05-07 · Spectrum Medical - myQA iON
FDA Device · Class II · 2025-05-07 · Iba Dosimetry - GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - L-Shaped Femoral Augment
FDA Device · Class II · 2025-05-07 · Waldemar Link And Kg Mfg Site - epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System
FDA Device · Class II · 2025-05-07 · Siemens Healthcare Diagnostics - Tibial Augment
FDA Device · Class II · 2025-05-07 · Waldemar Link And Kg Mfg Site - IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100
FDA Device · Class II · 2025-05-07 · Boston Scientific - Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
FDA Device · Class II · 2025-05-07 · Medline Industries Northfield - GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - Enhanced Verify Evaluation Handset (CFN HH90130FA)
FDA Device · Class II · 2025-05-07 · Medtronic Neuromodulation - GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China - Automated External Defibrillators, Model DDU-2300
FDA Device · Class II · 2025-05-07 · Defibtech - Hyperthermia Pump Procedure Kit
FDA Device · Class II · 2025-05-07 · Belmont Instrument - Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
FDA Device · Class II · 2025-05-07 · Medline Industries Northfield - Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
FDA Device · Class II · 2025-05-07 · Medline Industries Northfield - Posterior Femoral Augment
FDA Device · Class II · 2025-05-07 · Waldemar Link And Kg Mfg Site - Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A
FDA Device · Class II · 2025-05-07 · Medline Industries Northfield - Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-…
FDA Device · Class II · 2025-04-30 · Radiometer Medical Aps - Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Na…
FDA Device · Class I · 2025-04-30 · Conavi Medical - Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-prin…
FDA Device · Class II · 2025-04-30 · Remote Diagnostic Technologies - Beckman Coulter DxI 9000 Access Immunoassay Analyzer
FDA Device · Class II · 2025-04-30 · Beckman Coulter - Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Descri…
FDA Device · Class II · 2025-04-30 · Abbott Laboratories - Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Descri…
FDA Device · Class II · 2025-04-30 · Abbott Laboratories - InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
FDA Device · Class II · 2025-04-30 · Medtronic Minimed - Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays Syste…
FDA Device · Class II · 2025-04-30 · Micro X - BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01
FDA Device · Class II · 2025-04-30 · Carefusion 303 - Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202
FDA Device · Class II · 2025-04-30 · Zimmer - Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Descri…
FDA Device · Class II · 2025-04-30 · Abbott Laboratories - Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO…
FDA Device · Class II · 2025-04-30 · Merit Medical Systems - Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
FDA Device · Class II · 2025-04-30 · Ihb Operations B V - WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments
FDA Device · Class II · 2025-04-30 · Straumann Usa - stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103
FDA Device · Class II · 2025-04-30 · Tornier - Zenition 50
FDA Device · Class II · 2025-04-30 · Philips North America - The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope
FDA Device · Class II · 2025-04-30 · Maquet Cardiovascular - Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover")…
FDA Device · Class II · 2025-04-30 · Micro X - Zenition 70
FDA Device · Class II · 2025-04-30 · Philips Medical Systems Nederland B V - Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
FDA Device · Class II · 2025-04-30 · Merit Medical Systems - Philips Brilliance CT Big Bore, Software Version 4.8.0.10430
FDA Device · Class II · 2025-04-30 · Philips North America - Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
FDA Device · Class II · 2025-04-30 · Abbott - The Alinity m System is designed to automate the steps for nucleic acid testing
FDA Device · Class II · 2025-04-30 · Abbott Molecular - NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIEN…
FDA Device · Class II · 2025-04-30 · Medtronic Xomed - Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201
FDA Device · Class II · 2025-04-30 · Zimmer - Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203
FDA Device · Class II · 2025-04-30 · Zimmer - Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Descri…
FDA Device · Class II · 2025-04-30 · Abbott Laboratories - Veradius Unity
FDA Device · Class II · 2025-04-30 · Philips North America - Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203
FDA Device · Class II · 2025-04-30 · Zimmer - Zenition 70
FDA Device · Class II · 2025-04-30 · Philips North America - MAGEC 2 Rod, 5.0mm 90mm Standard
FDA Device · Class II · 2025-04-30 · Globus Medical - Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/tra…
FDA Device · Class II · 2025-04-30 · Edge Biologicals - Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202
FDA Device · Class II · 2025-04-30 · Zimmer - Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Descri…
FDA Device · Class II · 2025-04-30 · Abbott Laboratories - Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
FDA Device · Class II · 2025-04-30 · Abbott - Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard T…
FDA Device · Class I · 2025-04-23 · Avanos Medical - Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-0…
FDA Device · Class I · 2025-04-23 · Zoll Circulation - Refer to RES
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield
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)