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.
- Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM
FDA Device · Class II · 2025-03-19 · Aesculap - GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
FDA Device · Class II · 2025-03-19 · Ge Medical Systems - GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
FDA Device · Class II · 2025-03-19 · Ge Medical Systems - Z1 Femoral Hip System, Product Number 611777612
FDA Device · Class II · 2025-03-19 · Zimmer - Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM
FDA Device · Class II · 2025-03-19 · Aesculap - GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
FDA Device · Class II · 2025-03-19 · Ge Medical Systems - BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
FDA Device · Class I · 2025-03-19 · Carefusion 303 - Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C
FDA Device · Class II · 2025-03-19 · Zoll Medical - GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
FDA Device · Class II · 2025-03-19 · Ge Medical Systems - Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334
FDA Device · Class II · 2025-03-19 · Philips Medical Systems Nederland B V - Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to…
FDA Device · Class II · 2025-03-19 · Intuitive Surgical - Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM
FDA Device · Class II · 2025-03-19 · Aesculap - Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version…
FDA Device · Class II · 2025-03-19 · Truabutment - COR Disposable Kit, 8 mm
FDA Device · Class II · 2025-03-19 · Depuy Mitek A Johnson And Johnson - Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Descripti…
FDA Device · Class II · 2025-03-19 · Zoll Medical - Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, mode…
FDA Device · Class I · 2025-03-19 · Medtronic Perfusion Systems - BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
FDA Device · Class I · 2025-03-19 · Carefusion 303 - Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM
FDA Device · Class II · 2025-03-19 · Aesculap - Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6)…
FDA Device · Class II · 2025-03-19 · Zoll Medical - CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation
FDA Device · Class II · 2025-03-19 · Cardiofocus - GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
FDA Device · Class II · 2025-03-19 · Ge Medical Systems - Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Ro…
FDA Device · Class II · 2025-03-19 · Spectrum Medical - Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM
FDA Device · Class II · 2025-03-19 · Aesculap - Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduct…
FDA Device · Class II · 2025-03-19 · Cordis Us - DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
FDA Device · Class II · 2025-03-19 · Beckman Coulter - Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
FDA Device · Class II · 2025-03-19 · Stryker - Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A,…
FDA Device · Class II · 2025-03-19 · Zoll Medical - GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
FDA Device · Class II · 2025-03-19 · Ge Medical Systems - Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version: NA Product Descripti…
FDA Device · Class II · 2025-03-19 · Zoll Medical - Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A
FDA Device · Class II · 2025-03-19 · Zoll Medical - Philips IntelliSpace Cardiovascular software, Model 830089
FDA Device · Class II · 2025-03-12 · Philips Medical Systems Nederland B V - ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations suc…
FDA Device · Class II · 2025-03-12 · Hiossen - CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK…
FDA Device · Class II · 2025-03-12 · Kung Shin Plastics - ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations suc…
FDA Device · Class II · 2025-03-12 · Hiossen - MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
FDA Device · Class II · 2025-03-12 · Medtronic Minimed - Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport…
FDA Device · Class II · 2025-03-12 · Hiossen - AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager
FDA Device · Class II · 2025-03-12 · Integra Lifesciences - ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such…
FDA Device · Class II · 2025-03-12 · Hiossen - Vios Monitoring System Bedside Monitor Model BSM2050
FDA Device · Class II · 2025-03-12 · Murata Vios - MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
FDA Device · Class II · 2025-03-12 · Medtronic Minimed - Philips Connected Blood Glucose Meter, BGM 4
FDA Device · Class II · 2025-03-12 · Telcare - Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2…
FDA Device · Class II · 2025-03-12 · Medimaps Group - MIM software
FDA Device · Class II · 2025-03-12 · Mim Software - TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
FDA Device · Class II · 2025-03-12 · Tas Medical - DeRoyal REF 71-C5100NS Tubing, Suction, Connector
FDA Device · Class II · 2025-03-12 · Deroyal Industries - Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350…
FDA Device · Class I · 2025-03-12 · Micro Therapeutics - ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such…
FDA Device · Class II · 2025-03-12 · Hiossen - VARIPULSE Bi-Directional Ablation Catheter REF D141201
FDA Device · Class I · 2025-03-12 · Biosense Webster - MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
FDA Device · Class II · 2025-03-12 · Medtronic Minimed - BD BBL TB Stain Kit K, Catalog (REF): 212522
FDA Device · Class II · 2025-03-12 · Becton Dickinson And - MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
FDA Device · Class II · 2025-03-12 · Medtronic Minimed - MiniMed insulin pump, REF: 620G (MMT-1750)
FDA Device · Class II · 2025-03-12 · Medtronic Minimed - human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use
FDA Device · Class II · 2025-03-12 · Human Med Ag - MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
FDA Device · Class II · 2025-03-12 · Medtronic Minimed - Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894…
FDA Device · Class II · 2025-03-12 · Alcon Research - MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
FDA Device · Class II · 2025-03-12 · Medtronic Minimed - Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
FDA Device · Class I · 2025-03-12 · Baxter Healthcare - Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA Device · Class I · 2025-03-12 · Baxter Healthcare - Paradigm REF: MMT-712 and MMT-715
FDA Device · Class II · 2025-03-12 · Medtronic Minimed - CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
FDA Device · Class II · 2025-03-12 · Kung Shin Plastics - Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
FDA Device · Class II · 2025-03-12 · Medtronic Minimed - Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236
FDA Device · Class I · 2025-03-12 · Bard Peripheral Vascular - MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
FDA Device · Class II · 2025-03-12 · Medtronic Minimed - Paradigm insulin pump, REF: MMT-754
FDA Device · Class II · 2025-03-12 · Medtronic Minimed - Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport…
FDA Device · Class II · 2025-03-12 · Hiossen - Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal fa…
FDA Device · Class II · 2025-03-12 · Beckman Coulter - MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
FDA Device · Class II · 2025-03-12 · Medtronic Minimed - Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250…
FDA Device · Class I · 2025-03-12 · Micro Therapeutics - (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System
FDA Device · Class II · 2025-03-12 · Lumenis - PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower g…
FDA Device · Class II · 2025-03-05 · Pentax - SIGNA MR355, SIGNA MR360, NMRI system
FDA Device · Class II · 2025-03-05 · Ge Healthcare China - A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fractures of the distal t…
FDA Device · Class II · 2025-03-05 · Tyber Medical - SIGNA MR380, NMRI system, Non-US Only
FDA Device · Class II · 2025-03-05 · Ge Healthcare China - 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-1…
FDA Device · Class II · 2025-03-05 · Carefusion 303 - A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right
FDA Device · Class II · 2025-03-05 · Tyber Medical - A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalo…
FDA Device · Class II · 2025-03-05 · Tyber Medical - 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD…
FDA Device · Class II · 2025-03-05 · Carefusion 303 - LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest
FDA Device · Class II · 2025-03-05 · Physio Control - A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the…
FDA Device · Class II · 2025-03-05 · Tyber Medical - A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractures of the distal ti…
FDA Device · Class II · 2025-03-05 · Tyber Medical - 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS ME…
FDA Device · Class II · 2025-03-05 · Carefusion 303 - A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for Fixation of fractures…
FDA Device · Class II · 2025-03-05 · Tyber Medical - Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
FDA Device · Class II · 2025-03-05 · Leica Biosystems Nussloch - Optima MR360, NMRI system
FDA Device · Class II · 2025-03-05 · Ge Healthcare China - Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic di…
FDA Device · Class II · 2025-03-05 · Pentax - A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left
FDA Device · Class II · 2025-03-05 · Tyber Medical - A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal tibia
FDA Device · Class II · 2025-03-05 · Tyber Medical - IntelePACS (Image Fusion Module) - InteleViewer
FDA Device · Class II · 2025-03-05 · Intelerad Medical Systems - A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left
FDA Device · Class II · 2025-03-05 · Tyber Medical - SIGNA Creator, SIGNA Explorer, NMRI systems
FDA Device · Class II · 2025-03-05 · Ge Healthcare China - A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the distal tibia Model/Catalo…
FDA Device · Class II · 2025-03-05 · Tyber Medical - 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-0…
FDA Device · Class II · 2025-03-05 · Carefusion 303 - A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 770708042
FDA Device · Class II · 2025-03-05 · Tyber Medical - A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 770708062
FDA Device · Class II · 2025-03-05 · Tyber Medical - PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower…
FDA Device · Class II · 2025-03-05 · Pentax - Brivo MR355, NMRI system
FDA Device · Class II · 2025-03-05 · Ge Healthcare China - A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog…
FDA Device · Class II · 2025-03-05 · Tyber Medical - A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right
FDA Device · Class II · 2025-03-05 · Tyber Medical - BD Pyxis: MedFlex, REF: 1119-00
FDA Device · Class II · 2025-03-05 · Carefusion 303 - VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001
FDA Device · Class I · 2025-03-05 · Ventec Life Systems
Other years
2026 (2,088) · 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)