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.
- REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
FDA Device · Class II · 2025-07-02 · Becton Dickinson Infusion Therapy Systems - Jewel Precision Reusable Rigid Sterilization Container System
FDA Device · Class II · 2025-07-02 · Jewel Precision Sheet Metal And Machining - BD BACTEC MGIT 960 PZA Kit
FDA Device · Class II · 2025-07-02 · Becton Dickinson And - REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
FDA Device · Class II · 2025-07-02 · Becton Dickinson Infusion Therapy Systems - CDI OneView System BPM Probe: Cat
FDA Device · Class II · 2025-07-02 · Terumo Cardiovascular Systems - REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERI…
FDA Device · Class II · 2025-07-02 · Becton Dickinson Infusion Therapy Systems - REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
FDA Device · Class II · 2025-07-02 · Becton Dickinson Infusion Therapy Systems - MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the contro…
FDA Device · Class I · 2025-07-02 · Integra Lifesciences Neurosciences - Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife)
FDA Device · Class I · 2025-07-02 · Sunmed Holdings - REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
FDA Device · Class II · 2025-07-02 · Becton Dickinson Infusion Therapy Systems - Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 1088540351…
FDA Device · Class II · 2025-07-02 · Carefusion 303 - Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version:…
FDA Device · Class II · 2025-07-02 · Encore Medical - Jewel Precision Reusable Rigid Sterilization Container System
FDA Device · Class II · 2025-07-02 · Jewel Precision Sheet Metal And Machining - Spectral CT. Computed tomography X-ray system
FDA Device · Class II · 2025-07-02 · Philips North America - Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331
FDA Device · Class II · 2025-07-02 · Barco N V - Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version:…
FDA Device · Class II · 2025-07-02 · Encore Medical - REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
FDA Device · Class II · 2025-07-02 · Becton Dickinson Infusion Therapy Systems - DxI 9000 Access Immunoassay Analyzer C11137
FDA Device · Class II · 2025-07-02 · Beckman Coulter - GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog…
FDA Device · Class II · 2025-07-02 · Ge Medical Systems China - Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution…
FDA Device · Class II · 2025-07-02 · Recordati Rare Diseases - Omnipod 5 Automated Insulin Delivery System, iOS Application
FDA Device · Class II · 2025-07-02 · Insulet - Extended Tip Applicator, 15 CM, Box of 5
FDA Device · Class I · 2025-07-02 · Integra Lifesciences Neurosciences - REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
FDA Device · Class II · 2025-07-02 · Becton Dickinson Infusion Therapy Systems - LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acu…
FDA Device · Class II · 2025-07-02 · Jolife Ab - Extended Tip Applicator, 8CM, Box of 5
FDA Device · Class I · 2025-07-02 · Integra Lifesciences Neurosciences - Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version:…
FDA Device · Class II · 2025-07-02 · Encore Medical - Product: Atellica CH Diluent - CONS 2 x 1.5L
FDA Device · Class II · 2025-07-02 · Siemens Healthcare Diagnostics - Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-…
FDA Device · Class II · 2025-07-02 · Bigfoot Biomedical - Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445C…
FDA Device · Class II · 2025-06-25 · Balt Usa - ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003
FDA Device · Class II · 2025-06-25 · Icu Medical - SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030
FDA Device · Class II · 2025-06-25 · Chamberlain Technologies - Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068…
FDA Device · Class II · 2025-06-25 · Balt Usa - STA - Owren Koller
FDA Device · Class II · 2025-06-25 · Diagnostica Stago - Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with end…
FDA Device · Class II · 2025-06-25 · Preat - AcoSound
FDA Device · Class III · 2025-06-25 · Hangzhou Acosound Technology - SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
FDA Device · Class II · 2025-06-25 · Chamberlain Technologies - Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-…
FDA Device · Class I · 2025-06-25 · Dexcom - Lago X
FDA Device · Class II · 2025-06-25 · Spectral Instruments - UROSKOP Omnia Max
FDA Device · Class II · 2025-06-25 · Siemens Medical Solutions Usa - Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures
FDA Device · Class I · 2025-06-25 · Cook - ICU Medical Plum Solos, Item number 400011001
FDA Device · Class II · 2025-06-25 · Icu Medical - Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Descrip…
FDA Device · Class II · 2025-06-25 · Guangzhou Pluslife Biotech - Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N…
FDA Device · Class II · 2025-06-25 · Guangzhou Pluslife Biotech - Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
FDA Device · Class I · 2025-06-25 · Dexcom - 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-51…
FDA Device · Class II · 2025-06-25 · Fresenius Medical Care Holdings - UROSKOP Omnia
FDA Device · Class II · 2025-06-25 · Siemens Medical Solutions Usa - Ami HTX
FDA Device · Class II · 2025-06-25 · Spectral Instruments - Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
FDA Device · Class I · 2025-06-25 · Dexcom - SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
FDA Device · Class II · 2025-06-25 · Chamberlain Technologies - REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
FDA Device · Class II · 2025-06-25 · Orthofix Srl - SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
FDA Device · Class II · 2025-06-25 · Chamberlain Technologies - Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2),…
FDA Device · Class I · 2025-06-25 · Dexcom - GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
FDA Device · Class II · 2025-06-25 · Ohio Medical - Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410
FDA Device · Class II · 2025-06-18 · Remel - Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS…
FDA Device · Class II · 2025-06-18 · Olympus - Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm…
FDA Device · Class II · 2025-06-18 · Microtek Medical - OEC 3D
FDA Device · Class II · 2025-06-18 · Ge Medical Systems - Azurion R1.x and R2.x systems
FDA Device · Class II · 2025-06-18 · Philips Medical Systems Nederland B V - 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
FDA Device · Class II · 2025-06-18 · Baxter Healthcare - Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product Descr…
FDA Device · Class II · 2025-06-18 · Tecfen Medical - Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA…
FDA Device · Class II · 2025-06-18 · Olympus - Intera 1.5T Master/Nova Product Number: 781106
FDA Device · Class II · 2025-06-18 · Philips North America - Z-800 Infusion System
FDA Device · Class I · 2025-06-18 · Zyno Medical - BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241
FDA Device · Class II · 2025-06-18 · Bd Switzerland Sarl - Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System
FDA Device · Class II · 2025-06-18 · Stryker - BD Texium: 3 mL, REF: MY8003-0006
FDA Device · Class II · 2025-06-18 · Bd Switzerland Sarl - Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly
FDA Device · Class II · 2025-06-18 · Microaire Surgical Instruments - Achieva XR Product Numbers: (1) 781153, (2) 781253
FDA Device · Class II · 2025-06-18 · Philips North America - LOWER EXTREMITY, Model: NCEX20I
FDA Device · Class II · 2025-06-18 · American Contract Systems - Intera 1.5T Achieva Nova Product Number: 781172
FDA Device · Class II · 2025-06-18 · Philips North America - Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves whe…
FDA Device · Class II · 2025-06-18 · Cardinal Health 200 - BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
FDA Device · Class II · 2025-06-18 · Copan Italia - Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Descr…
FDA Device · Class II · 2025-06-18 · Tecfen Medical - Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 1001336…
FDA Device · Class II · 2025-06-18 · Bd Switzerland Sarl - BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
FDA Device · Class II · 2025-06-18 · Bd Switzerland Sarl - Intera 1.5T Achieva IT Nova Product Number: 781175
FDA Device · Class II · 2025-06-18 · Philips North America - Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)
FDA Device · Class II · 2025-06-18 · Turncare - Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150…
FDA Device · Class II · 2025-06-18 · Olympus - SCD Comfort Knee Length Small, SKU 84021
FDA Device · Class II · 2025-06-18 · Cardinal Health 200 - Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Descr…
FDA Device · Class II · 2025-06-18 · Tecfen Medical - Intera 1.5T Omni/Stellar
FDA Device · Class II · 2025-06-18 · Philips North America - Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Descripti…
FDA Device · Class II · 2025-06-18 · Tecfen Medical - Z-800F Infusion System
FDA Device · Class I · 2025-06-18 · Zyno Medical - Femoral Nail, RIGHT T2 GTN 8x300 mm
FDA Device · Class II · 2025-06-18 · Stryker - Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, T…
FDA Device · Class II · 2025-06-18 · Olympus - Intera 1.5T Explorer/Nova Dual Product Number: 781108
FDA Device · Class II · 2025-06-18 · Philips North America - SmartPath to dStream for 1.5T¿
FDA Device · Class II · 2025-06-18 · Philips North America - EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the…
FDA Device · Class II · 2025-06-18 · Quantum Surgical Sas - Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicab…
FDA Device · Class II · 2025-06-18 · Ortho Clinical Diagnostics - Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00…
FDA Device · Class II · 2025-06-18 · Natus Neurology - Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)
FDA Device · Class II · 2025-06-18 · Turncare - Femoral Nail, LEFT T2 GTN 8x300 mm
FDA Device · Class II · 2025-06-18 · Stryker - KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960
FDA Device · Class II · 2025-06-18 · Microbiologics - Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Descr…
FDA Device · Class II · 2025-06-18 · Tecfen Medical - Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No softwar…
FDA Device · Class II · 2025-06-18 · Tecfen Medical - Intera Achieva 1.5T Pulsar
FDA Device · Class II · 2025-06-18 · Philips North America - Allon 2001
FDA Device · Class II · 2025-06-18 · Belmont Instrument - Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves…
FDA Device · Class II · 2025-06-18 · Cardinal Health 200 - DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
FDA Device · Class II · 2025-06-18 · Beckman Coulter - MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses store…
FDA Device · Class II · 2025-06-18 · Ge Medical Systems Information Technologies
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