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.
- Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325
FDA Device · Class II · 2025-10-01 · Philips North America - Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000
FDA Device · Class II · 2025-10-01 · Maquet Cardiovascular - Allura CV20
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Chromophare Surgical Light System, REF: CH00000001
FDA Device · Class II · 2025-10-01 · Stryker Communications - Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number:…
FDA Device · Class II · 2025-10-01 · Philips North America - Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307
FDA Device · Class II · 2025-10-01 · Philips North America - Allura Xper FD20/15
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3.…
FDA Device · Class II · 2025-10-01 · Philips North America - Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
FDA Device · Class II · 2025-10-01 · Biomet - Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306
FDA Device · Class II · 2025-10-01 · Philips North America - Allura Xper FD20/20
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C
FDA Device · Class I · 2025-10-01 · Medline Industries Northfield - Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD P…
FDA Device · Class II · 2025-10-01 · Ortoma Ab - BeneVision N1 Patient Monitor (N1)
FDA Device · Class II · 2025-10-01 · Mindray Ds Usa - Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332
FDA Device · Class II · 2025-10-01 · Philips North America - STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Cod…
FDA Device · Class II · 2025-10-01 · Ethicon - Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Extractor Pro RX Retrieval Balloon Catheter
FDA Device · Class II · 2025-10-01 · Boston Scientific - Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code RE…
FDA Device · Class II · 2025-10-01 · Baxter Healthcare - Allura Xper FD20/10
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Automated Impella Controller (AIC) with the below brands and product codes
FDA Device · Class I · 2025-10-01 · Abiomed - MyDay Toric, stenfilcon A) Contact Lens
FDA Device · Class II · 2025-10-01 · Coopervision - Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B
FDA Device · Class I · 2025-10-01 · Medline Industries Northfield - t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
FDA Device · Class II · 2025-10-01 · Tandem Diabetes Care - Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008
FDA Device · Class II · 2025-10-01 · Philips Medical Systems Nederland B V - Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
FDA Device · Class II · 2025-09-24 · Folsom Metal Products - SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
FDA Device · Class II · 2025-09-24 · C R Bard - The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in th…
FDA Device · Class II · 2025-09-24 · Bigtree Sales - Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Versio…
FDA Device · Class II · 2025-09-24 · Agilent Technologies Denmark Aps - Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/…
FDA Device · Class II · 2025-09-24 · Exactech - Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.…
FDA Device · Class II · 2025-09-24 · Exactech - Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist c…
FDA Device · Class I · 2025-09-24 · Max Mobility - Chemistry Products LAC Slides
FDA Device · Class II · 2025-09-24 · Ortho Clinical Diagnostics - Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.2…
FDA Device · Class II · 2025-09-24 · Philips Medical Systems Cleveland - SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
FDA Device · Class II · 2025-09-24 · C R Bard - UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
FDA Device · Class II · 2025-09-24 · Beckman Coulter - Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version…
FDA Device · Class II · 2025-09-24 · Agilent Technologies Denmark Aps - i-STAT CG4+ cartridge (white)
FDA Device · Class II · 2025-09-24 · Abbott Point - Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
FDA Device · Class II · 2025-09-24 · Folsom Metal Products - UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
FDA Device · Class II · 2025-09-24 · Beckman Coulter - Heartstring III Proximal Seal System
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
FDA Device · Class II · 2025-09-24 · Folsom Metal Products - Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist…
FDA Device · Class I · 2025-09-24 · Max Mobility - MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for cl…
FDA Device · Class II · 2025-09-24 · Medical Information Technology - Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
FDA Device · Class II · 2025-09-24 · Beckman Coulter - VITROS Chemistry Products LAC Slides
FDA Device · Class II · 2025-09-24 · Ortho Clinical Diagnostics - Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
FDA Device · Class II · 2025-09-24 · Folsom Metal Products - SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
FDA Device · Class II · 2025-09-24 · C R Bard - Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version:…
FDA Device · Class II · 2025-09-24 · Agilent Technologies Denmark Aps - Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
FDA Device · Class II · 2025-09-24 · Boston Scientific Neuromodulation - Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist…
FDA Device · Class I · 2025-09-24 · Max Mobility - i-STAT EG6+ cartridge
FDA Device · Class II · 2025-09-24 · Abbott Point - Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
FDA Device · Class II · 2025-09-24 · Beckman Coulter - 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
FDA Device · Class I · 2025-09-24 · 3m - Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
FDA Device · Class II · 2025-09-24 · Folsom Metal Products - Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
FDA Device · Class II · 2025-09-24 · Folsom Metal Products - i-STAT CG8+ cartridge
FDA Device · Class II · 2025-09-24 · Abbott Point - i-STAT EG7+ cartridge
FDA Device · Class II · 2025-09-24 · Abbott Point - CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
FDA Device · Class II · 2025-09-17 · Corneat Vision - Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Versi…
FDA Device · Class II · 2025-09-17 · Quest International - Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543
FDA Device · Class II · 2025-09-17 · Siemens Healthcare Diagnostics - 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10F…
FDA Device · Class II · 2025-09-17 · Merit Medical Systems - Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Descript…
FDA Device · Class II · 2025-09-17 · B Braun Medical S - Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Descript…
FDA Device · Class II · 2025-09-17 · Contract Medical International - Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Des…
FDA Device · Class II · 2025-09-17 · Encore Medical - QuickVue: Dipstick Strep A Test: 50T, REF: 20108
FDA Device · Class II · 2025-09-17 · Quidel - Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
FDA Device · Class II · 2025-09-17 · Boston Scientific - ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
FDA Device · Class II · 2025-09-17 · Boston Scientific - Halyard, CPT BASIC IR PACK. Model Number: 1646381
FDA Device · Class II · 2025-09-17 · Avid Medical - Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER-ILC
FDA Device · Class II · 2025-09-17 · Wasatch Photonics - Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: M…
FDA Device · Class II · 2025-09-17 · Encore Medical - TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles
FDA Device · Class II · 2025-09-17 · Omnia Medical - Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011
FDA Device · Class II · 2025-09-17 · Boston Scientific - Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
FDA Device · Class II · 2025-09-17 · Seaspine Orthopedics - NOxBOXi Nitric Oxide Delivery System
FDA Device · Class II · 2025-09-17 · Noxbox - Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240,…
FDA Device · Class II · 2025-09-17 · Boston Scientific - PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
FDA Device · Class II · 2025-09-17 · Orthofix U S - Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011
FDA Device · Class II · 2025-09-17 · Boston Scientific - IntelliSpace Cardiovascular, Software 8.0.0.4
FDA Device · Class II · 2025-09-17 · Philips Medical Systems Nederland B V - Halyard, ENT PACK. Model Number: JACK421-04
FDA Device · Class II · 2025-09-17 · Avid Medical - LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed
FDA Device · Class II · 2025-09-17 · Waldemar Link And Kg Mfg Site - TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree
FDA Device · Class II · 2025-09-17 · Omnia Medical - ViziShot 2FLEX. Single Use Aspiration Needle
FDA Device · Class I · 2025-09-17 · Olympus - Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180
FDA Device · Class II · 2025-09-17 · Boston Scientific - Artis Pheno
FDA Device · Class II · 2025-09-17 · Siemens Medical Solutions Usa - Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Mat…
FDA Device · Class II · 2025-09-17 · Encore Medical - Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Descripti…
FDA Device · Class II · 2025-09-17 · Encore Medical - MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutatio…
FDA Device · Class II · 2025-09-10 · Caris Life Sciences - Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS…
FDA Device · Class II · 2025-09-10 · Integra Lifesciences Neurosciences - LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indi…
FDA Device · Class II · 2025-09-10 · Physio Control - DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
FDA Device · Class I · 2025-09-10 · Medtronic Perfusion Systems - Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer
FDA Device · Class II · 2025-09-10 · Icu Medical - WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020
FDA Device · Class I · 2025-09-10 · Boston Scientific - RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Sof…
FDA Device · Class II · 2025-09-10 · Raysearch Laboratories Ab
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)