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.
- GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27
FDA Device · Class II · 2025-01-15 · Ge Medical Systems - Xhibit Telemetry Receiver with Software, Model 96280
FDA Device · Class II · 2025-01-15 · Spacelabs Healthcare - Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile
FDA Device · Class II · 2025-01-15 · Aerin Medical - Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000…
FDA Device · Class II · 2025-01-15 · Ge Medical Systems - 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUN…
FDA Device · Class II · 2025-01-15 · Stryker - Brand Name: 3B Medical, Inc
FDA Device · Class II · 2025-01-15 · 3b Medical - Xhibit Telemetry Receiver, Model 96280, with Service Manual
FDA Device · Class II · 2025-01-15 · Spacelabs Healthcare - VasoView HemoPro 2 Endoscopic Vessel Harvesting System
FDA Device · Class I · 2025-01-15 · Maquet Cardiovascular - AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port
FDA Device · Class II · 2025-01-15 · Applied Medical Technology - Smaxel Fractional CO2 Laser, a Class IV medical laser system
FDA Device · Class II · 2025-01-15 · Ids - EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion i…
FDA Device · Class II · 2025-01-15 · Elucent Medical - Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
FDA Device · Class II · 2025-01-15 · Ge Medical Systems - Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
FDA Device · Class II · 2025-01-15 · Ge Medical Systems - The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and pl…
FDA Device · Class III · 2025-01-15 · Qualigen - Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
FDA Device · Class II · 2025-01-15 · Ge Medical Systems - GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12
FDA Device · Class II · 2025-01-15 · Ge Medical Systems - Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hor…
FDA Device · Class II · 2025-01-15 · Beckman Coulter - Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
FDA Device · Class II · 2025-01-15 · Nipro Renal Soultions Usa - Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System
FDA Device · Class I · 2025-01-15 · Maquet Cardiovascular - JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
FDA Device · Class I · 2025-01-15 · Jiangsu Jumao X Care Medical Equipment - Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
FDA Device · Class I · 2025-01-15 · Fresenius Kabi Usa - VACUETTE SAFELINK, REF: 450210
FDA Device · Class II · 2025-01-15 · Greiner Bio One - Dialyzer Optiflux 160NRe
FDA Device · Class II · 2025-01-15 · Fresenius Medical Care Holdings - Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
FDA Device · Class II · 2025-01-15 · Ge Medical Systems - SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app…
FDA Device · Class II · 2025-01-08 · Medtronic Neuromodulation - SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app ver…
FDA Device · Class II · 2025-01-08 · Medtronic Neuromodulation - Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site
FDA Device · Class II · 2025-01-08 · Carwild - Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
FDA Device · Class II · 2025-01-08 · Carwild - Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - See DocMan
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - SUC-4300S, Rigid Intracardiac Sucker Fluted Tip
FDA Device · Class II · 2025-01-08 · Med Michigan Holding - Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
FDA Device · Class II · 2025-01-08 · Baxter Healthcare - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
FDA Device · Class II · 2025-01-08 · Baxter Healthcare - SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E…
FDA Device · Class II · 2025-01-08 · Medtronic Neuromodulation - Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedu…
FDA Device · Class II · 2025-01-08 · Carwild - 3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orth…
FDA Device · Class II · 2025-01-08 · 3m Unitek - See DocMan
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - See DocMan
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app…
FDA Device · Class II · 2025-01-08 · Medtronic Neuromodulation - Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001
FDA Device · Class II · 2025-01-08 · Angiodynamics - Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G
FDA Device · Class II · 2025-01-08 · Medline Industries Northfield - EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
FDA Device · Class II · 2025-01-01 · Encore Medical - O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or dia…
FDA Device · Class II · 2025-01-01 · Abbott Vascular - STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatat…
FDA Device · Class II · 2025-01-01 · Abbott Vascular - Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures
FDA Device · Class II · 2025-01-01 · Abbott Vascular - LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink,…
FDA Device · Class II · 2025-01-01 · Waldemar Link And Kg Mfg Site - O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
FDA Device · Class II · 2025-01-01 · O And M Halyard - BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically su…
FDA Device · Class II · 2025-01-01 · Straight Smile - Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit
FDA Device · Class II · 2025-01-01 · Beckman Coulter - KIT,SPINE LH Convenience kit, SKU DYNJ906448A
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - DIEP FLAP Convenience kit, SKU DYNJ910120
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057
FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics - The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates u…
FDA Device · Class II · 2025-01-01 · Abbott Medical - Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows:…
FDA Device · Class II · 2025-01-01 · Becton Dickinson And Bd Bio Sciences - TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis
FDA Device · Class II · 2025-01-01 · Limacorporate S P A - Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - epoc NXS Host
FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics - ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures
FDA Device · Class II · 2025-01-01 · Abbott Vascular - Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
FDA Device · Class II · 2025-01-01 · O And M Halyard - Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/…
FDA Device · Class II · 2025-01-01 · Seaspine Orthopedics - FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - epoc NXS Host
FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics - Galaxy System (GAL-001)
FDA Device · Class II · 2025-01-01 · Noah Medical - epoc NXS Host
FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics - StatStrip Glucose Ketone (mmol/L) Hospital Meter System
FDA Device · Class I · 2025-01-01 · Nova Biomedical - Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the de…
FDA Device · Class II · 2025-01-01 · Becton Dickinson And Bd Bio Sciences - StatStrip Glucose Hospital Meter System
FDA Device · Class I · 2025-01-01 · Nova Biomedical - ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - epoc NXS Host
FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics - MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - epoc NXS Host
FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics - FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic fo…
FDA Device · Class II · 2025-01-01 · Becton Dickinson And Bd Bio Sciences - FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
FDA Device · Class II · 2025-01-01 · Becton Dickinson And Bd Bio Sciences - MISHA Knee System Implant Small, Left, REF: 2-1001
FDA Device · Class II · 2025-01-01 · Moximed - Clarity Precision Grip Attachments, for use in orthodontic treatment
FDA Device · Class II · 2025-01-01 · 3m Health Care Business - Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Versio…
FDA Device · Class II · 2025-01-01 · Seaspine Orthopedics - Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T
FDA Device · Class II · 2025-01-01 · Medline Industries Northfield - epoc NXS Host
FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics - Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible…
FDA Device · Class I · 2025-01-01 · Braemar Manufacturing
Other years
2026 (2,088) · 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)