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.
- Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
FDA Device · Class II · 2025-08-20 · Spark Biomedical - Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not…
FDA Device · Class II · 2025-08-20 · Spineart - Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description…
FDA Device · Class I · 2025-08-20 · Thoratec - Plastic Trial Head Brown, 7 mm neck length
FDA Device · Class II · 2025-08-20 · Waldemar Link And Kg Mfg Site - GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
FDA Device · Class III · 2025-08-20 · Diversatek Healthcare - GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - Prosthesis Head B, 28 mm, 7 mm neck length
FDA Device · Class II · 2025-08-20 · Waldemar Link And Kg Mfg Site - GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - DreamStation Auto BiPAP. Non-Continuous Ventilator
FDA Device · Class I · 2025-08-20 · Philips Respironics - Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
FDA Device · Class II · 2025-08-20 · Merit Medical Systems - 3mensio Workstation (Vascular Fenestrated) software
FDA Device · Class II · 2025-08-20 · Pie Medical Imaging B V - GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not…
FDA Device · Class II · 2025-08-20 · Spineart - GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
FDA Device · Class II · 2025-08-20 · Boston Scientific - Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product De…
FDA Device · Class II · 2025-08-20 · Encore Medical - Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
FDA Device · Class II · 2025-08-20 · Beckman Coulter - GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system
FDA Device · Class I · 2025-08-20 · Boston Scientific - HemosIL LMW Heparin Controls
FDA Device · Class II · 2025-08-20 · Instrumentation Laboratory - GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
FDA Device · Class II · 2025-08-20 · Merit Medical Systems - Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercur…
FDA Device · Class I · 2025-08-20 · Ambu - Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K0…
FDA Device · Class II · 2025-08-20 · Merit Medical Systems - GE Signa Artist, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
FDA Device · Class II · 2025-08-20 · Merit Medical Systems - Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate…
FDA Device · Class I · 2025-08-20 · Thoratec - GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2025-08-20 · Ge Medical Systems - Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll G…
FDA Device · Class II · 2025-08-20 · Carefree Surgical Specialties - Bartels ELISA Legionella Urinary Antigen
FDA Device · Class II · 2025-08-20 · Trinity Biotech Usa - Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and…
FDA Device · Class II · 2025-08-20 · Insightra Medical - DreamStation Auto
FDA Device · Class I · 2025-08-20 · Philips Respironics - Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product De…
FDA Device · Class II · 2025-08-20 · Encore Medical - Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS…
FDA Device · Class II · 2025-08-20 · Carefree Surgical Specialties - Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
FDA Device · Class I · 2025-08-20 · Baxter Healthcare - LAP CHOLE PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
FDA Device · Class II · 2025-08-13 · Becton Dickinson And Bd Bio Sciences - BD Trucount Controls, 30 Test - REF: 340335
FDA Device · Class II · 2025-08-13 · Becton Dickinson And Bd Bio Sciences - BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
FDA Device · Class I · 2025-08-13 · Flexicare Medical Dongguan - BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
FDA Device · Class I · 2025-08-13 · Carefusion 303 - Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
FDA Device · Class I · 2025-08-13 · Flexicare Medical Dongguan - DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
FDA Device · Class II · 2025-08-13 · Beckman Coulter - ROBOTIC URO/GYN PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-01…
FDA Device · Class I · 2025-08-13 · Flexicare Medical Dongguan - LAPAROSCOPY PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - GS ENDOSCOPY PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - One-piece Guedel airway, size 3, ISO 9.0, yellow
FDA Device · Class II · 2025-08-13 · Intersurgical - UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Device · Class II · 2025-08-13 · Beckman Coulter - BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-33…
FDA Device · Class I · 2025-08-13 · Flexicare Medical Dongguan - DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
FDA Device · Class II · 2025-08-13 · Beckman Coulter - BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV
FDA Device · Class I · 2025-08-13 · Carefusion 303 - Microbore Extension Set with 0.2 Micron Filter
FDA Device · Class I · 2025-08-13 · B Braun Medical - LAVH PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - DA VINCI PACK URO/PROSTATE. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - One-piece Guedel airway, size 2, ISO 8.0, green
FDA Device · Class II · 2025-08-13 · Intersurgical - DAVINCI UROLOGY. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Device · Class II · 2025-08-13 · Beckman Coulter - LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
FDA Device · Class III · 2025-08-13 · Drg International - GENERAL ROBOTIC PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test
FDA Device · Class II · 2025-08-13 · Nuclein - GENERAL LAPAROSCOPY TRAY. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - MAJOR THORACOSCOPY BASIN. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205
FDA Device · Class II · 2025-08-13 · Beckman Coulter - DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - epoc BGEM BUN Test Card [25pk]. Material Number: 10736515
FDA Device · Class II · 2025-08-13 · Siemens Healthcare Diagnostics - PACK GENERAL ROBOTIC. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135
FDA Device · Class II · 2025-08-13 · Stryker - Plum Duo Infusion System, List Number: 400020401
FDA Device · Class I · 2025-08-13 · Icu Medical - Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
FDA Device · Class II · 2025-08-13 · Philips Medical Systems Cleveland - CT DAVINCI. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - CARDIAC ROBOT PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - LAPAROSCOPIC TRAY. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
FDA Device · Class I · 2025-08-13 · Flexicare Medical Dongguan - GEN LAPAROSCOPY PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - HVI CARDIAC ROBOT PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
FDA Device · Class II · 2025-08-13 · Beckman Coulter - UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
FDA Device · Class II · 2025-08-13 · Beckman Coulter - GYN ROBOTIC PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
FDA Device · Class I · 2025-08-13 · Flexicare Medical Dongguan - PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - ROBOTIC PROSTATECTOMY PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - GYN LAPAROSCOPY PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - PARTIAL NEPHRECTOMY PACK. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - LAPAROSCOPIC GYN. Medical convenience kit
FDA Device · Class II · 2025-08-13 · Avid Medical - BostonSight PROSE Lens
FDA Device · Class II · 2025-08-06 · Boston Foundation For Sight - Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) So…
FDA Device · Class II · 2025-08-06 · Osteotec - Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
FDA Device · Class II · 2025-08-06 · Capnia - SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129
FDA Device · Class II · 2025-08-06 · 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)