FDA Device · 2024

FDA Device recalls in 2024

RecallRadar indexes 3,393 FDA Device recall notices published in 2024. By classification: 392 Class I, 2,970 Class II, 31 Class III.

• Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angio…
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-…
  FDA Device · Class II · 2024-10-23 · Beckman Coulter
• BlueFIRE Inflation Device, REF: IN10140
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• IntelliSystem Inflation Device, REF: IN1525/D
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX
  FDA Device · Class I · 2024-10-23 · Datex Ohmeda
• Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access P…
  FDA Device · Class II · 2024-10-23 · Spineology
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• GE Heathcare Giraffe OmniBed
  FDA Device · Class I · 2024-10-23 · Datex Ohmeda
• Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-…
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device
  FDA Device · Class III · 2024-10-23 · Beckman Coulter
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Vanta Implantable Neurostimulator (INS), Model 977006
  FDA Device · Class II · 2024-10-23 · Medtronic Neuromodulation
• Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILIT…
  FDA Device · Class II · 2024-10-23 · Nova Ortho Med
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiogr…
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
  FDA Device · Class II · 2024-10-23 · Medline Industries Northfield
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• KINOVA Jaco assistive robot
  FDA Device · Class I · 2024-10-23 · Kinova
• Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
  FDA Device · Class II · 2024-10-23 · Leica Biosystems Nussloch
• StabiliT TOUCH Syringe, REF: IN8VCF/B
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and…
  FDA Device · Class II · 2024-10-23 · Stryker
• Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used…
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
  FDA Device · Class II · 2024-10-23 · Xtant Medical Holdings
• DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• MEDLINE OPEN HEART, REF DYNJ904261B
  FDA Device · Class II · 2024-10-23 · Medline Industries Northfield
• McKesson Cardiology Hemo
  FDA Device · Class II · 2024-10-23 · Change Healthcare Canada
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
  FDA Device · Class II · 2024-10-23 · Cue Health
• Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile
  FDA Device · Class II · 2024-10-23 · Wilson Cook Medical
• Horizon Cardiology Hemo
  FDA Device · Class II · 2024-10-23 · Change Healthcare Canada
• Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003
  FDA Device · Class II · 2024-10-23 · Leica Biosystems Nussloch
• EVIS EXERA III Video System Center Model Number CV-190
  FDA Device · Class II · 2024-10-23 · Olympus
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• MEDLINE OPEN HEART PACK, REF DYNJ66216C
  FDA Device · Class II · 2024-10-23 · Medline Industries Northfield
• MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
  FDA Device · Class II · 2024-10-23 · Medline Industries Northfield
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• MEDLINE KIT CV I II, REF DYNJ906071B
  FDA Device · Class II · 2024-10-23 · Medline Industries Northfield
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• basixSKY Inflation Device, REF: SKY1802
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Sy…
  FDA Device · Class II · 2024-10-23 · Beckman Coulter
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILI…
  FDA Device · Class II · 2024-10-23 · Nova Ortho Med
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBI…
  FDA Device · Class II · 2024-10-23 · Nova Ortho Med
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US
  FDA Device · Class II · 2024-10-23 · Leica Biosystems Nussloch
• Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03
  FDA Device · Class II · 2024-10-23 · Leica Biosystems Nussloch
• Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe i…
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector An…
  FDA Device · Class II · 2024-10-23 · Merit Medical Systems
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL
  FDA Device · Class II · 2024-10-23 · Leica Biosystems Nussloch
• Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US
  FDA Device · Class II · 2024-10-23 · Boston Scientific
• MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
  FDA Device · Class II · 2024-10-16 · Medline Industries Northfield
• IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) In…
  FDA Device · Class II · 2024-10-16 · Philips North America
• Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and rev…
  FDA Device · Class II · 2024-10-16 · Howmedica Osteonics
• Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
  FDA Device · Class II · 2024-10-16 · Philips North America
• The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of o…
  FDA Device · Class II · 2024-10-16 · Quantum Surgical Sas
• NxTAG Respiratory Pathogen Panel, REF: I051C0447
  FDA Device · Class II · 2024-10-16 · Luminex Molecular Diagnostics
• MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Mod…
  FDA Device · Class II · 2024-10-16 · Integra Lifesciences
• Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system
  FDA Device · Class II · 2024-10-16 · Inspire Medical Systems
• Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes
  FDA Device · Class II · 2024-10-16 · Windstone Medical Packaging
• BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution provi…
  FDA Device · Class II · 2024-10-16 · Becton Dickinson And
• MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U
  FDA Device · Class II · 2024-10-16 · Medline Industries Northfield
• Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes
  FDA Device · Class II · 2024-10-16 · Windstone Medical Packaging
• Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes
  FDA Device · Class II · 2024-10-16 · Windstone Medical Packaging
• Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes
  FDA Device · Class II · 2024-10-16 · Windstone Medical Packaging
• Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242
  FDA Device · Class II · 2024-10-16 · Cook
• GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120
  FDA Device · Class II · 2024-10-16 · Ge Healthcare
• Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF
  FDA Device · Class I · 2024-10-16 · Zyno Medical
• MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT
  FDA Device · Class II · 2024-10-16 · Medline Industries Northfield
• Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes
  FDA Device · Class II · 2024-10-16 · Windstone Medical Packaging
• iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
  FDA Device · Class II · 2024-10-16 · Atrium Medical
• NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
  FDA Device · Class II · 2024-10-16 · Luminex Molecular Diagnostics
• Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
  FDA Device · Class II · 2024-10-16 · Auris Health
• Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-im…
  FDA Device · Class II · 2024-10-16 · Agfa Healthcare Nv
• FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
  FDA Device · Class II · 2024-10-16 · Qualigen
• MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
  FDA Device · Class II · 2024-10-16 · Howmedica Osteonics
• StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intende…
  FDA Device · Class II · 2024-10-16 · Medtronic Navigation
• Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system
  FDA Device · Class II · 2024-10-16 · Inspire Medical Systems
• Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB
  FDA Device · Class II · 2024-10-16 · Auris Health
• 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
  FDA Device · Class II · 2024-10-16 · 3m Health Care Business
• Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
  FDA Device · Class II · 2024-10-16 · Medline Industries Northfield
• The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end a…
  FDA Device · Class II · 2024-10-16 · Stryker Neurovascular
• Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137
  FDA Device · Class II · 2024-10-16 · Beckman Coulter
• Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only
  FDA Device · Class I · 2024-10-09 · Percussionaire
• DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
  FDA Device · Class II · 2024-10-09 · Feng Chun Yuan Medical Equipment Shenzhen
• Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
  FDA Device · Class II · 2024-10-09 · Tornier
• Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System
  FDA Device · Class II · 2024-10-09 · Outset Medical
• MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750
  FDA Device · Class I · 2024-10-09 · Medtronic Minimed
• Miami J Select Collar, Catalog: MJS-101
  FDA Device · Class II · 2024-10-09 · Ossur H F

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)