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.
- ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - Catalog No. 8888160325
FDA Device · Class II · 2025-06-04 · Cardinal Health 200 - HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686
FDA Device · Class II · 2025-05-28 · Cook - Product Name: Evolution Upgrade 1.5T
FDA Device · Class II · 2025-05-28 · Philips North America - Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
FDA Device · Class I · 2025-05-28 · C R Bard - Product Name: SmartPath to Ingenia Elition X
FDA Device · Class II · 2025-05-28 · Philips North America - Product Name: SmartPath to dStream for 1.5T
FDA Device · Class II · 2025-05-28 · Philips North America - Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ra…
FDA Device · Class I · 2025-05-28 · C R Bard - Product Name: SmartPath to dStream for 3.0T
FDA Device · Class II · 2025-05-28 · Philips North America - Product Name: MR 7700
FDA Device · Class II · 2025-05-28 · Philips North America - Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
FDA Device · Class I · 2025-05-28 · C R Bard - Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row)
FDA Device · Class I · 2025-05-28 · Ethicon Endo Surgery - Product Name: Upgrade to MR 7700
FDA Device · Class II · 2025-05-28 · Philips North America - Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
FDA Device · Class I · 2025-05-28 · Baxter Healthcare - Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
FDA Device · Class I · 2025-05-28 · C R Bard - Product Name: Ingenia Elition X
FDA Device · Class II · 2025-05-28 · Philips North America - META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
FDA Device · Class II · 2025-05-28 · Smith And Nephew - Product Name: Ingenia 3.0T
FDA Device · Class II · 2025-05-28 · Philips North America - Product Name: Ingenia 1.5T CX
FDA Device · Class II · 2025-05-28 · Philips North America - Product Name: Ingenia Ambition X
FDA Device · Class II · 2025-05-28 · Philips North America - Product Name: Ingenia 3.0T CX
FDA Device · Class II · 2025-05-28 · Philips North America - TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care prof…
FDA Device · Class II · 2025-05-28 · Echopixel - Product Name: Ingenia 1.5T S
FDA Device · Class II · 2025-05-28 · Philips North America - Centerline Biomedical IOPS Guidewire 2, REF ATW-2
FDA Device · Class I · 2025-05-28 · Centerline Biomedical - HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
FDA Device · Class II · 2025-05-28 · Advanced Bionics - Product Name: Ingenia Elition S
FDA Device · Class II · 2025-05-28 · Philips North America - Product Name: Evolution Upgrade 3.0T
FDA Device · Class II · 2025-05-28 · Philips North America - Product Name: Ingenia 1.5T
FDA Device · Class II · 2025-05-28 · Philips North America - Product Name: SmartPath to dStream for XR and 3.0T
FDA Device · Class II · 2025-05-28 · Philips North America - True 3D Viewer, Model: EP-00003
FDA Device · Class II · 2025-05-28 · Echopixel - BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865
FDA Device · Class II · 2025-05-28 · Becton Dickinson Infusion Therapy Systems - Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957
FDA Device · Class II · 2025-05-28 · Cook - PhenoMATRIX
FDA Device · Class II · 2025-05-28 · Copan Wasp - Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
FDA Device · Class I · 2025-05-28 · C R Bard - Product Name: Ingenia Ambition S
FDA Device · Class II · 2025-05-28 · Philips North America - Product Name: MR 5300
FDA Device · Class II · 2025-05-28 · Philips North America - Intera 1.5T Power/Pulsar, Model Number: 781105
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test…
FDA Device · Class II · 2025-05-21 · Abbott Molecular - TufTex Over-the-Wire Embolectomy Catheter
FDA Device · Class II · 2025-05-21 · Lemaitre Vascular - BIB Balloon in Balloon Dilatation Catheter
FDA Device · Class II · 2025-05-21 · Numed - Pruitt Irrigation Occlusion Catheter
FDA Device · Class II · 2025-05-21 · Lemaitre Vascular - Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit
FDA Device · Class II · 2025-05-21 · Avid Medical - CMS8000 Patient Monitor
FDA Device · Class II · 2025-05-21 · Contec Medical Systems - iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems
FDA Device · Class I · 2025-05-21 · Medical Depot - Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit
FDA Device · Class II · 2025-05-21 · Avid Medical - KliniTray
FDA Device · Class II · 2025-05-21 · Klinika Mdical Gmb - PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezo…
FDA Device · Class II · 2025-05-21 · Richard Wolf - Intera 1.0T Omni/Stellar, Model Number: 781102
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chai…
FDA Device · Class II · 2025-05-21 · Abbott Molecular - SmartPath to dStream for 1.5T, Model Number: 782146
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - Intera 1.5T, Model Numbers: 781195 and 781295
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - Enterprise 1.5T, Model Number: 781145
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description:…
FDA Device · Class I · 2025-05-21 · Vyaire Medical - MedicaLyte Liquid Bicarbonate Concentrate
FDA Device · Class I · 2025-05-21 · Nipro Renal Soultions Usa - Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Weight,…
FDA Device · Class II · 2025-05-21 · Meddev - Intera 1.5T R11, Model Number: 781170
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - Intera 3.0T Quasar Dual, Model Number: 781150
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - Intera CV, Model Number: 781107
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
FDA Device · Class II · 2025-05-21 · Avid Medical - Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
FDA Device · Class II · 2025-05-21 · Medline Industries Northfield - Intera 1.0T Power/Pulsar, Model Number: 781103
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - KliniTray Platte Faxitron ,groB "R" sterile
FDA Device · Class II · 2025-05-21 · Klinika Mdical Gmb - Centurion Sterile Weitlaner Retractor, Reorder: 67315
FDA Device · Class II · 2025-05-21 · Medline Industries Northfield - Intera 1.5T Master/Nova, Model Number: 781106
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002
FDA Device · Class I · 2025-05-21 · Baxter Healthcare - Intera 1.5T Explorer/Nova Dual, Model Number: 781108
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
FDA Device · Class II · 2025-05-21 · Icu Medical - Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description:…
FDA Device · Class I · 2025-05-21 · Vyaire Medical - Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesi…
FDA Device · Class II · 2025-05-21 · Cook - Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004
FDA Device · Class I · 2025-05-21 · Baxter Healthcare - Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation syste…
FDA Device · Class II · 2025-05-21 · Augmedics - SmartPath to dStream for 3.0T, Model Number: 782145
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065
FDA Device · Class II · 2025-05-21 · Beckman Coulter - Intera 1.5T Omni/Stellar, Model Number: 781104
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - Intera 0.5T Standard, Model Number: 781101
FDA Device · Class II · 2025-05-21 · Philips Medical Systems Nederland B V - Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight,…
FDA Device · Class II · 2025-05-21 · Meddev - FoundationOne Companion Diagnostic (F1CDx)
FDA Device · Class II · 2025-05-21 · Foundation Medicine - Pruitt Occlusion Catheter
FDA Device · Class II · 2025-05-21 · Lemaitre Vascular - GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainag…
FDA Device · Class II · 2025-05-14 · Galt Medical - Intraocular Lens. enVista Envy IOL, All models starting with EN
FDA Device · Class I · 2025-05-14 · Bausch And Lomb Surgical - Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
FDA Device · Class II · 2025-05-14 · Science And Bio Materials - CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system
FDA Device · Class I · 2025-05-14 · Smiths Medical Asd - Blueprint Software, BPUE001
FDA Device · Class II · 2025-05-14 · Tornier S - INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter
FDA Device · Class II · 2025-05-14 · Integra Lifesciences Neurosciences - CODMAN Disposable Perforator, 14mm
FDA Device · Class I · 2025-05-14 · Integra Lifesciences Neurosciences - CADD-Solis VIP Ambulatory Infusion Pump
FDA Device · Class I · 2025-05-14 · Smiths Medical Asd - CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51
FDA Device · Class I · 2025-05-14 · Smiths Medical Asd - Artix MT Thrombectomy Device, REF: 32-102
FDA Device · Class II · 2025-05-14 · Inari Medical Oak Canyon - Washer Disinfector Aquadis 56
FDA Device · Class II · 2025-05-14 · Getinge Disinfection Ab - CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm
FDA Device · Class I · 2025-05-14 · Integra Lifesciences Neurosciences - Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
FDA Device · Class II · 2025-05-14 · Galt Medical - Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set
FDA Device · Class II · 2025-05-14 · Ambu - Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
FDA Device · Class II · 2025-05-14 · Remote Diagnostic Technologies - GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other int…
FDA Device · Class II · 2025-05-14 · Galt Medical - Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
FDA Device · Class II · 2025-05-14 · Medline Industries Northfield - Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures…
FDA Device · Class II · 2025-05-14 · Galt Medical - Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 008412681…
FDA Device · Class II · 2025-05-14 · Galt Medical
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)