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.
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S…
FDA Device · Class II · 2025-01-29 · Olympus - The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including…
FDA Device · Class II · 2025-01-29 · Stryker - Bodor P and C series laser cutting machines
FDA Device · Class II · 2025-01-29 · Jinan Bodor Cnc Machine - Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S…
FDA Device · Class II · 2025-01-29 · Olympus - Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Versi…
FDA Device · Class II · 2025-01-29 · Trinity Sterile - stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
FDA Device · Class II · 2025-01-29 · Stryker - BD Pyxis MedStation ES (Med ES Main), REF 323
FDA Device · Class II · 2025-01-29 · Carefusion 303 - Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers
FDA Device · Class II · 2025-01-29 · Randox Laboratories - Brand Name: Tacy Medical, Inc
FDA Device · Class II · 2025-01-29 · Trinity Sterile - Otological Ventilation Tube - T-Tube 9mm - Double - Silicone
FDA Device · Class II · 2025-01-29 · Adept Medical - stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
FDA Device · Class II · 2025-01-29 · Stryker - Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type…
FDA Device · Class II · 2025-01-29 · Olympus - Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S…
FDA Device · Class II · 2025-01-29 · Olympus - BD Pyxis Med 4000 Auxiliary (AUX), REF 314
FDA Device · Class II · 2025-01-29 · Carefusion 303 - Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished),…
FDA Device · Class II · 2025-01-29 · Ortho Clinical Diagnostics - Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model…
FDA Device · Class II · 2025-01-29 · St Jude Medical - Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number:…
FDA Device · Class II · 2025-01-29 · Trinity Sterile - Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S…
FDA Device · Class II · 2025-01-29 · Olympus - CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only
FDA Device · Class II · 2025-01-29 · Integra Lifesciences - VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001,…
FDA Device · Class I · 2025-01-29 · Percussionaire - Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bo…
FDA Device · Class II · 2025-01-29 · Integrity Implants - BD Pyxis MedStation 4000 Main, REF 303
FDA Device · Class II · 2025-01-29 · Carefusion 303 - CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only
FDA Device · Class II · 2025-01-29 · Integra Lifesciences - Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalo…
FDA Device · Class II · 2025-01-29 · Trinity Sterile - Otological Ventilation Tube - T-Tube 6mm - Silicone
FDA Device · Class II · 2025-01-29 · Adept Medical - Otological Ventilation Tube - T-Tube 12mm - Double - Silicone
FDA Device · Class II · 2025-01-29 · Adept Medical - Otological Ventilation Tube - T-Tube 9mm - Silicone
FDA Device · Class II · 2025-01-29 · Adept Medical - Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 690400…
FDA Device · Class II · 2025-01-29 · Ortho Clinical Diagnostics - BD Pyxis MedStation ES AUX, REF 324
FDA Device · Class II · 2025-01-29 · Carefusion 303 - Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Numbe…
FDA Device · Class II · 2025-01-29 · Olympus - Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
FDA Device · Class II · 2025-01-29 · Baxter Healthcare - DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
FDA Device · Class II · 2025-01-29 · Medtronic Perfusion Systems - Otological Ventilation Tube - Donaldson - Double - Blue Silicone
FDA Device · Class II · 2025-01-29 · Adept Medical - CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Networ…
FDA Device · Class II · 2025-01-29 · St Jude Medical - CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Netwo…
FDA Device · Class II · 2025-01-29 · St Jude Medical - Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers
FDA Device · Class II · 2025-01-29 · Randox Laboratories - Otological Ventilation Tube - T-Tube 12mm - Silicone
FDA Device · Class II · 2025-01-29 · Adept Medical - Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Co…
FDA Device · Class II · 2025-01-29 · O And M Halyard - Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S…
FDA Device · Class II · 2025-01-29 · Olympus - EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
FDA Device · Class II · 2025-01-29 · Medtronic Perfusion Systems - Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China)…
FDA Device · Class II · 2025-01-29 · Ortho Clinical Diagnostics - Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S…
FDA Device · Class II · 2025-01-29 · Olympus - BD PCR Cartridges used with MAX System
FDA Device · Class II · 2025-01-29 · Becton Dickinson And - Baxter Solution Set with Duo-Vent Spike, REF 2R8404
FDA Device · Class II · 2025-01-29 · Baxter Healthcare - Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version:…
FDA Device · Class II · 2025-01-29 · Trinity Sterile - Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S…
FDA Device · Class II · 2025-01-29 · Olympus - Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
FDA Device · Class II · 2025-01-29 · Baxter Healthcare - Otological Ventilation Tube - T-Tube 6mm - Double - Silicone
FDA Device · Class II · 2025-01-29 · Adept Medical - Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S…
FDA Device · Class II · 2025-01-29 · Olympus - Otological Ventilation Tube - Donaldson - Blue Silicone
FDA Device · Class II · 2025-01-29 · Adept Medical - Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
FDA Device · Class II · 2025-01-29 · Microvention - Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
FDA Device · Class II · 2025-01-29 · Medtronic Perfusion Systems - Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S…
FDA Device · Class II · 2025-01-29 · Olympus - CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only
FDA Device · Class II · 2025-01-29 · Integra Lifesciences - Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
FDA Device · Class II · 2025-01-22 · Sin Sistema De Implante Nacional - Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube
FDA Device · Class I · 2025-01-22 · Trokamed - 8MM,PROGRASP FORCEPS,IS4000 REF 471093
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6…
FDA Device · Class II · 2025-01-22 · Coloplast Manufacturing Us - Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050…
FDA Device · Class I · 2025-01-22 · Mercury Enterprises - 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - 8MM,CADIERE FORCEPS,IS4000 REF 471049
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7…
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging - Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200
FDA Device · Class II · 2025-01-22 · Tornier S - 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a vari…
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow…
FDA Device · Class I · 2025-01-22 · Nuwellis - Augustine Surgical Inc
FDA Device · Class II · 2025-01-22 · Augustine Temperature Management - Hillrom Temperature Management Controller, MP, Model # 2083516
FDA Device · Class II · 2025-01-22 · Augustine Temperature Management - Change Healthcare Cardiology Hemo software
FDA Device · Class II · 2025-01-22 · A L I Technologies - 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
FDA Device · Class II · 2025-01-22 · Noa Medical Industries - Augustine Surgical Inc
FDA Device · Class II · 2025-01-22 · Augustine Temperature Management - Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12
FDA Device · Class II · 2025-01-22 · Cardinal Health 200 - GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging - ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
FDA Device · Class II · 2025-01-22 · Sklar Instruments - OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100
FDA Device · Class II · 2025-01-22 · Isotis Orthobiologics - VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
FDA Device · Class I · 2025-01-22 · Boston Scientific - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236
FDA Device · Class II · 2025-01-22 · Sklar Instruments - 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1
FDA Device · Class II · 2025-01-22 · Cardinal Health 200 - LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30
FDA Device · Class II · 2025-01-22 · Olympus - 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
FDA Device · Class I · 2025-01-22 · Baxter Healthcare - Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
FDA Device · Class II · 2025-01-22 · Cook Biotech - 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286
FDA Device · Class II · 2025-01-22 · Sklar Instruments - GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging - 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging - ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814
FDA Device · Class II · 2025-01-22 · Sklar Instruments - ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
FDA Device · Class II · 2025-01-22 · Sklar Instruments - Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: N…
FDA Device · Class II · 2025-01-22 · Quidel Ortho - ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
FDA Device · Class II · 2025-01-22 · Sklar Instruments - 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918
FDA Device · Class II · 2025-01-22 · Sklar Instruments - Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube
FDA Device · Class I · 2025-01-22 · Trokamed - GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging
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)