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.
- GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
FDA Device · Class II · 2024-07-17 · Ge Vingmed Ultrasound As - TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
FDA Device · Class II · 2024-07-17 · American Contract Systems - ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening hea…
FDA Device · Class II · 2024-07-17 · Zoll Medical - TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
FDA Device · Class II · 2024-07-17 · American Contract Systems - ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U
FDA Device · Class II · 2024-07-17 · American Contract Systems - Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060
FDA Device · Class II · 2024-07-17 · Microspecialties - UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
FDA Device · Class II · 2024-07-17 · American Contract Systems - HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F
FDA Device · Class II · 2024-07-17 · American Contract Systems - KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
FDA Device · Class II · 2024-07-17 · American Contract Systems - AURORA Surgiscope System
FDA Device · Class II · 2024-07-17 · Integra Lifesciences - TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA
FDA Device · Class II · 2024-07-17 · American Contract Systems - 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
FDA Device · Class II · 2024-07-17 · American Contract Systems - AHAR50K STANDARD ARTHROSCOPY PACK - 291852
FDA Device · Class II · 2024-07-17 · American Contract Systems - Braun Thermoscan¿ PRO 6000 Ear Thermometer
FDA Device · Class II · 2024-07-17 · Baxter Healthcare - iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light)
FDA Device · Class II · 2024-07-17 · Baxter Healthcare - Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that cli…
FDA Device · Class II · 2024-07-17 · Baxter Healthcare - Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3
FDA Device · Class II · 2024-07-17 · Cardinal Health 200 - TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
FDA Device · Class II · 2024-07-17 · American Contract Systems - RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
FDA Device · Class II · 2024-07-17 · American Contract Systems - KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A
FDA Device · Class II · 2024-07-17 · American Contract Systems - Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system
FDA Device · Class II · 2024-07-17 · Echonous - ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
FDA Device · Class II · 2024-07-17 · American Contract Systems - BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
FDA Device · Class I · 2024-07-17 · Synergetics - CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
FDA Device · Class II · 2024-07-17 · American Contract Systems - 24K Premium Lense, Distributed by Updream Inc
FDA Device · Class II · 2024-07-17 · Ontact - Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
FDA Device · Class II · 2024-07-17 · Microspecialties - TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
FDA Device · Class II · 2024-07-17 · American Contract Systems - Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination betw…
FDA Device · Class II · 2024-07-17 · Svs - TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
FDA Device · Class II · 2024-07-17 · American Contract Systems - ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
FDA Device · Class II · 2024-07-17 · American Contract Systems - MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B
FDA Device · Class II · 2024-07-17 · American Contract Systems - The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope
FDA Device · Class II · 2024-07-17 · Maquet Cardiovascular - RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
FDA Device · Class II · 2024-07-17 · American Contract Systems - 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
FDA Device · Class I · 2024-07-17 · Synergetics - BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
FDA Device · Class I · 2024-07-17 · Synergetics - LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
FDA Device · Class II · 2024-07-17 · American Contract Systems - Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description
FDA Device · Class II · 2024-07-17 · Microspecialties - RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-07-17 · Fresenius Medical Care Holdings - ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
FDA Device · Class II · 2024-07-17 · American Contract Systems - HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B
FDA Device · Class II · 2024-07-17 · American Contract Systems - ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includ…
FDA Device · Class II · 2024-07-10 · Siemens Ag Siemens Healthcare - Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Fo…
FDA Device · Class II · 2024-07-10 · Medline Industries Northfield - Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a…
FDA Device · Class II · 2024-07-10 · Stryker - Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #D…
FDA Device · Class II · 2024-07-10 · Medline Industries Northfield - Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
FDA Device · Class II · 2024-07-10 · Abbott Medical - Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use
FDA Device · Class II · 2024-07-10 · Beckman Coulter - BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB…
FDA Device · Class II · 2024-07-10 · Carefusion 303 - WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries
FDA Device · Class II · 2024-07-10 · Wom World - IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
FDA Device · Class II · 2024-07-10 · Angiodynamics - Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
FDA Device · Class II · 2024-07-10 · Zyno Medical - Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5",…
FDA Device · Class II · 2024-07-10 · Medline Industries Northfield - Avalon Ultrasound Transducer
FDA Device · Class II · 2024-07-10 · Philips North America - EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only
FDA Device · Class II · 2024-07-10 · Microport Orthopedics - HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
FDA Device · Class II · 2024-07-10 · Horiba Instruments - BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1…
FDA Device · Class II · 2024-07-10 · Carefusion 303 - The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns
FDA Device · Class II · 2024-07-10 · Stryker - VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754
FDA Device · Class II · 2024-07-10 · Ortho Clinical Diagnostics - ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includ…
FDA Device · Class II · 2024-07-10 · Siemens Ag Siemens Healthcare - EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user inter…
FDA Device · Class II · 2024-07-10 · Olympus - Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Len…
FDA Device · Class II · 2024-07-10 · Stryker Sustainability Solutions - Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Ca…
FDA Device · Class II · 2024-07-10 · Seaspine Orthopedics - Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scisso…
FDA Device · Class II · 2024-07-10 · Medline Industries Northfield - Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ0404…
FDA Device · Class II · 2024-07-10 · Medline Industries Northfield - Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Ele…
FDA Device · Class I · 2024-07-10 · Megadyne Medical Products - ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includ…
FDA Device · Class II · 2024-07-10 · Siemens Ag Siemens Healthcare - Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L
FDA Device · Class II · 2024-07-10 · Exactech - VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 760…
FDA Device · Class III · 2024-07-10 · Ortho Clinical Diagnostics - Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Sc…
FDA Device · Class II · 2024-07-10 · Medline Industries Northfield - Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline…
FDA Device · Class II · 2024-07-10 · Medline Industries Northfield - DxI 9000 Access Immunoassay Analyzer, C11137
FDA Device · Class II · 2024-07-10 · Beckman Coulter - BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
FDA Device · Class II · 2024-07-10 · Carefusion 303 - Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Ca…
FDA Device · Class II · 2024-07-10 · Seaspine Orthopedics - Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Compone…
FDA Device · Class II · 2024-07-10 · Nalu Medical - This product is a single use sterile device that is used to direct the lesion to the targeted site
FDA Device · Class II · 2024-07-10 · Stryker - First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer
FDA Device · Class II · 2024-07-10 · First Source - Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electroph…
FDA Device · Class II · 2024-07-10 · Ge Medical Systems Information Technologies - Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number:…
FDA Device · Class I · 2024-07-10 · Megadyne Medical Products - Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curve…
FDA Device · Class II · 2024-07-10 · Medline Industries Northfield - First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer
FDA Device · Class II · 2024-07-10 · First Source - Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Mod…
FDA Device · Class I · 2024-07-10 · Megadyne Medical Products - AMT Initial Placement Dilator Set
FDA Device · Class II · 2024-07-10 · Applied Medical Technology - Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curv…
FDA Device · Class II · 2024-07-10 · Medline Industries Northfield - Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analy…
FDA Device · Class II · 2024-07-03 · Sight Diagnostics - Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-…
FDA Device · Class II · 2024-07-03 · Medtronic - Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine acce…
FDA Device · Class II · 2024-07-03 · Dental Ez Group Star Dental Division - Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm…
FDA Device · Class II · 2024-07-03 · Roche Diabetes Care - The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. Vaso…
FDA Device · Class II · 2024-07-03 · Maquet Cardiovascular - COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
FDA Device · Class II · 2024-07-03 · Aspen Surgical - Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0…
FDA Device · Class I · 2024-07-03 · Baxter Healthcare - Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a vari…
FDA Device · Class II · 2024-07-03 · Cook - PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - Inspire Model 3028, IV Implantable Pulse Generator
FDA Device · Class I · 2024-07-03 · Inspire Medical Systems - SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems
FDA Device · Class I · 2024-07-03 · Philips North America - CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident pa…
FDA Device · Class II · 2024-07-03 · Siemens Medical Solutions Usa
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)