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.
- KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
FDA Device · Class II · 2025-07-23 · Microbiologics - Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
FDA Device · Class I · 2025-07-23 · Baxter Healthcare - Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000
FDA Device · Class II · 2025-07-23 · Beyond Laser Systems - Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO…
FDA Device · Class II · 2025-07-23 · Waismed - Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000
FDA Device · Class II · 2025-07-23 · Beyond Laser Systems - SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000
FDA Device · Class II · 2025-07-23 · Icu Medical - Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NI…
FDA Device · Class II · 2025-07-23 · Waismed - Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
FDA Device · Class II · 2025-07-23 · Beckman Coulter - Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Softwar…
FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics - Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minif…
FDA Device · Class II · 2025-07-16 · Neurovision Medical Products - Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
FDA Device · Class II · 2025-07-16 · Preat - Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guid…
FDA Device · Class I · 2025-07-16 · Given Imaging - TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Device · Class III · 2025-07-16 · Stratasys - Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the per…
FDA Device · Class II · 2025-07-16 · Boston Scientific - Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: T…
FDA Device · Class I · 2025-07-16 · Edwards Lifesciences - Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product De…
FDA Device · Class I · 2025-07-16 · Edwards Lifesciences - TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Device · Class III · 2025-07-16 · Stratasys - Brand Name: Alcon Laboratories, Inc
FDA Device · Class II · 2025-07-16 · Alcon Research - VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart
FDA Device · Class II · 2025-07-16 · Boston Scientific - Brand Name: Alcon Laboratories, Inc
FDA Device · Class II · 2025-07-16 · Alcon Research - Brand Name: Alcon Laboratories, Inc
FDA Device · Class II · 2025-07-16 · Alcon Research - Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: T…
FDA Device · Class I · 2025-07-16 · Edwards Lifesciences - Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description:…
FDA Device · Class I · 2025-07-16 · Edwards Lifesciences - O-arm O2 Imaging System
FDA Device · Class II · 2025-07-16 · Medtronic Navigation Boxborough - Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
FDA Device · Class II · 2025-07-16 · Ge Medical Systems Israel Functional Imaging - VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1)…
FDA Device · Class II · 2025-07-16 · Boston Scientific - Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
FDA Device · Class II · 2025-07-16 · Ge Medical Systems Israel Functional Imaging - VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-…
FDA Device · Class II · 2025-07-16 · Boston Scientific - Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2…
FDA Device · Class I · 2025-07-16 · Baxter Healthcare - Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: T…
FDA Device · Class I · 2025-07-16 · Edwards Lifesciences - Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem exten…
FDA Device · Class II · 2025-07-16 · Canary Medical - TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Device · Class III · 2025-07-16 · Stratasys - TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Device · Class III · 2025-07-16 · Stratasys - TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Device · Class III · 2025-07-16 · Stratasys - Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product De…
FDA Device · Class I · 2025-07-16 · Edwards Lifesciences - Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Pro…
FDA Device · Class I · 2025-07-16 · Baxter Healthcare - Philips S7-2 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Lig…
FDA Device · Class III · 2025-07-09 · Lumithera - Philips S7-3t Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - Change Healthcare Cardiology Hemodynamics Software
FDA Device · Class II · 2025-07-09 · Change Healthcare Canada - Philips V6-2 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - Philips L12-3 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - BiPAP V30 Auto Ventilator
FDA Device · Class I · 2025-07-09 · Philips Respironics - BiPAP A40 Ventilator
FDA Device · Class I · 2025-07-09 · Philips Respironics - HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
FDA Device · Class II · 2025-07-09 · Hardy Diagnostics - Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
FDA Device · Class II · 2025-07-09 · Medline Industries Northfield - Philips L9-3 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - VITROS Chemistry Products OP Reagent Gen 15
FDA Device · Class II · 2025-07-09 · Ortho Clinical Diagnostics - Philips VL13-5 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
FDA Device · Class II · 2025-07-09 · C R Bard - Philips S5-1 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
FDA Device · Class II · 2025-07-09 · C R Bard - ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
FDA Device · Class II · 2025-07-09 · Siemens Healthcare Diagnostics - ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includ…
FDA Device · Class II · 2025-07-09 · Siemens Medical Solutions Usa - ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
FDA Device · Class II · 2025-07-09 · Siemens Healthcare Diagnostics - Servo-n Ventilator System
FDA Device · Class I · 2025-07-09 · Maquet Critical Care Ab - interventional fluoroscopic x-ray system
FDA Device · Class II · 2025-07-09 · Siemens Medical Solutions Usa - BiPAP A30 Ventilators
FDA Device · Class I · 2025-07-09 · Philips Respironics - The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multip…
FDA Device · Class II · 2025-07-09 · Hemocue Ab - Philips X8-2t Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003
FDA Device · Class II · 2025-07-09 · Onkos Surgical - Philips XL14-3 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - interventional fluoroscopic x-ray system
FDA Device · Class II · 2025-07-09 · Siemens Medical Solutions Usa - Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, R…
FDA Device · Class II · 2025-07-09 · Medline Industries Northfield - Apex Knee System
FDA Device · Class II · 2025-07-09 · Corin Medical - Philips X6-1 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - Change Healthcare Cardiology Hemo Software
FDA Device · Class II · 2025-07-09 · Change Healthcare Canada - Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
FDA Device · Class II · 2025-07-09 · Medline Industries Northfield - Philips eL18-4 EMT Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - Servo-u Ventilator System
FDA Device · Class I · 2025-07-09 · Maquet Critical Care Ab - Philips X7-2t Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - Philips 3D9-3v Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - Philips L12-4 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
FDA Device · Class II · 2025-07-09 · Siemens Healthcare Diagnostics - Servo-u MR Ventilator System
FDA Device · Class I · 2025-07-09 · Maquet Critical Care Ab - Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2…
FDA Device · Class II · 2025-07-09 · Ortho Clinical Diagnostics - Philips S8-3t Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - Brand Name: VITROS
FDA Device · Class II · 2025-07-09 · Ortho Clinical Diagnostics - ADVIA¿ 120/2120/2120i SETpoint Calibrator
FDA Device · Class II · 2025-07-09 · Siemens Healthcare Diagnostics - interventional fluoroscopic x-ray system
FDA Device · Class II · 2025-07-09 · Siemens Medical Solutions Usa - Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
FDA Device · Class II · 2025-07-09 · Ortho Clinical Diagnostics - REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
FDA Device · Class II · 2025-07-09 · C R Bard - REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation
FDA Device · Class II · 2025-07-09 · Becton Dickinson And Bd Bio Sciences - Philips C5-1 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - Philips C5-2 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - Philips eL18-4 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - Philips X5-1 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation
FDA Device · Class II · 2025-07-09 · Becton Dickinson And Bd Bio Sciences - ColoSense Test Kit, Part No. 80-001, component of ColoSense test
FDA Device · Class II · 2025-07-09 · Geneoscopy - Philips C9-5EC Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - Philips L8-4 Transducer
FDA Device · Class II · 2025-07-09 · Philips Ultrasound - REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487
FDA Device · Class II · 2025-07-02 · Beckman Coulter - PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
FDA Device · Class II · 2025-07-02 · Limacorporate S P A - Extended Tip Applicator 8CM, Box of 1
FDA Device · Class I · 2025-07-02 · Integra Lifesciences Neurosciences - GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
FDA Device · Class II · 2025-07-02 · Ge Medical Systems China - Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version:…
FDA Device · Class II · 2025-07-02 · Encore Medical - PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
FDA Device · Class II · 2025-07-02 · Limacorporate S P A - REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
FDA Device · Class II · 2025-07-02 · Becton Dickinson Infusion Therapy Systems - Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
FDA Device · Class II · 2025-07-02 · Medline Industries Northfield - REF: 381811, 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
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)