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.
- Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-pow…
FDA Device · Class II · 2024-12-25 · Coopersurgical - mint Lesion, Software Versions: 3.10.0 and 3.10.1
FDA Device · Class II · 2024-12-25 · Mint Medical - HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B
FDA Device · Class II · 2024-12-25 · Medline Industries Northfield - Walcott Bipolar Pencil 25 Gauge Straight
FDA Device · Class I · 2024-12-25 · Kirwan Surgical Products - Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 98993…
FDA Device · Class II · 2024-12-25 · Spectranetics - Ambler Surgical Bipolar Pencil 25 Gauge Straight
FDA Device · Class I · 2024-12-25 · Kirwan Surgical Products - Duravent Silicone Ventilation Tube
FDA Device · Class II · 2024-12-25 · Olympus - HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4
FDA Device · Class II · 2024-12-25 · Medline Industries Northfield - EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR
FDA Device · Class II · 2024-12-25 · Microport Orthopedics - Galaxy System (GAL-001)
FDA Device · Class II · 2024-12-25 · Noah Medical - Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
FDA Device · Class II · 2024-12-25 · Philips North America - OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight
FDA Device · Class I · 2024-12-25 · Kirwan Surgical Products - Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthe…
FDA Device · Class I · 2024-12-25 · Draeger Medical - Augustine Surgical Inc
FDA Device · Class II · 2024-12-25 · Augustine Temperature Management - Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrical…
FDA Device · Class II · 2024-12-25 · Coopersurgical - mint Lesion, Software Versions: 3.9.0 through 3.9.5
FDA Device · Class II · 2024-12-25 · Mint Medical - Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 ED…
FDA Device · Class I · 2024-12-25 · Medtronic Neurosurgery - Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrica…
FDA Device · Class II · 2024-12-25 · Coopersurgical - Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040…
FDA Device · Class I · 2024-12-25 · Medtronic Neurosurgery - Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record…
FDA Device · Class II · 2024-12-25 · Spacelabs Healthcare - Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anest…
FDA Device · Class I · 2024-12-25 · Draeger Medical - Optikon Bipolar Pencil 25 Gauge Straight
FDA Device · Class I · 2024-12-25 · Kirwan Surgical Products - OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - Hillrom Temperature Management Controller, MP, Model # 2083516
FDA Device · Class II · 2024-12-25 · Augustine Temperature Management - Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight
FDA Device · Class I · 2024-12-25 · Kirwan Surgical Products - Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long
FDA Device · Class I · 2024-12-25 · Kirwan Surgical Products - Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An e…
FDA Device · Class II · 2024-12-25 · Coopersurgical - OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2
FDA Device · Class II · 2024-12-25 · Medline Industries Northfield - Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrical…
FDA Device · Class II · 2024-12-25 · Coopersurgical - OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight
FDA Device · Class I · 2024-12-25 · Kirwan Surgical Products - Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device…
FDA Device · Class II · 2024-12-25 · Coopersurgical - HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B
FDA Device · Class II · 2024-12-25 · Medline Industries Northfield - Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory elec…
FDA Device · Class II · 2024-12-25 · Spacelabs Healthcare - Augustine Surgical Inc
FDA Device · Class II · 2024-12-25 · Augustine Temperature Management - Philips Allura Xper Systems (R7.6-R8.1)
FDA Device · Class II · 2024-12-18 · Philips Medical Systems Nederland B V - Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
FDA Device · Class II · 2024-12-18 · Hermes Medical Solutions Ab - Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
FDA Device · Class II · 2024-12-18 · Cardinal Health 200 - Microscissor Tip (Disposable)
FDA Device · Class II · 2024-12-18 · Microline Surgical - Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, A…
FDA Device · Class II · 2024-12-18 · Cardinal Health 200 - BD Pyxis MedStation ES, REF: 323
FDA Device · Class II · 2024-12-18 · Carefusion 303 - DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060
FDA Device · Class II · 2024-12-18 · Diasorin - MICRO-X Rover Mobile X-ray System, # MXU-RV19
FDA Device · Class II · 2024-12-18 · Micro X - Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
FDA Device · Class II · 2024-12-18 · Hologic - MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA Device · Class II · 2024-12-18 · Micro X - ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants
FDA Device · Class II · 2024-12-18 · Icu Medical - Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
FDA Device · Class II · 2024-12-18 · Noah Medical - MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA Device · Class II · 2024-12-18 · Micro X - BD Pyxis CII Safe ES, REF: 1116-00
FDA Device · Class II · 2024-12-18 · Carefusion 303 - Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact pa…
FDA Device · Class II · 2024-12-18 · Beckman Coulter - BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
FDA Device · Class II · 2024-12-18 · Carefusion 303 - Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. D…
FDA Device · Class II · 2024-12-18 · Folsom Metal Products - DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Lar…
FDA Device · Class II · 2024-12-18 · Folsom Metal Products - MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
FDA Device · Class II · 2024-12-11 · Orthoscan - MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - GE Healthcare Revolution Ascend Elite, Model Number 6967000-100
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic…
FDA Device · Class II · 2024-12-11 · Advanced Medical Solutions - GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Eli…
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to cont…
FDA Device · Class II · 2024-12-11 · Advanced Medical Solutions - BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro suscep…
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - Ziehm Solo
FDA Device · Class II · 2024-12-11 · Orthoscan - MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - GE Healthcare Revolution Maxima M, Model Number, 6670000-2
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580,…
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - BIORAPTOR Suture Anchors
FDA Device · Class II · 2024-12-11 · Smith And Nephew - BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
FDA Device · Class II · 2024-12-11 · Cartiva - BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - Ziehm Vision RFD. Interventional fluoroscopic x-ray system
FDA Device · Class II · 2024-12-11 · Orthoscan - Fusion Pro 24, Model 17000
FDA Device · Class II · 2024-12-11 · Epilog Laser - MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - Ziehm Vision system, x-ray, tomography, computed
FDA Device · Class II · 2024-12-11 · Orthoscan - Ziehm Vision FD. Interventional fluoroscopic x-ray system
FDA Device · Class II · 2024-12-11 · Orthoscan - GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - Spectral CT and Spectral CT Plus
FDA Device · Class II · 2024-12-11 · Philips North America - MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - GE Healthcare Revolution ACE, Model number 6670000-3
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - Diode Laser Hair Removal model: WLA-01
FDA Device · Class II · 2024-12-11 · Wingderm Electro Optics - MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - GE Healthcare Optima 680 Expert, Model number 6670000
FDA Device · Class II · 2024-12-11 · Ge Healthcare China
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)