FDA Device · 2023
FDA Device recalls in 2023
RecallRadar indexes 2,477 FDA Device recall notices published in 2023. By classification: 495 Class I, 1,959 Class II, 23 Class III.
- Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replaceme…
FDA Device · Class II · 2023-11-29 · Biomet - Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
FDA Device · Class II · 2023-11-29 · Biomet - Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
FDA Device · Class II · 2023-11-29 · Medtronic - Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replaceme…
FDA Device · Class II · 2023-11-29 · Biomet - GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
FDA Device · Class II · 2023-11-29 · Instrumentation Laboratory - Intera 1.5T
FDA Device · Class II · 2023-11-29 · Philips North America - Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item…
FDA Device · Class II · 2023-11-29 · Biomet - Ingenia 1.5T CX
FDA Device · Class II · 2023-11-29 · Philips North America - Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replaceme…
FDA Device · Class II · 2023-11-29 · Biomet - Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Mo…
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea)
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum)
FDA Device · Class II · 2023-11-29 · Aizu Olympus - DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from trau…
FDA Device · Class II · 2023-11-29 · Musculoskeletal Transplant Foundation - Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replaceme…
FDA Device · Class II · 2023-11-29 · Biomet - Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
FDA Device · Class II · 2023-11-29 · Biomet - Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacem…
FDA Device · Class II · 2023-11-29 · Biomet - GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
FDA Device · Class II · 2023-11-29 · Instrumentation Laboratory - EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0
FDA Device · Class II · 2023-11-29 · Boston Scientific - Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
FDA Device · Class II · 2023-11-29 · Biomet - Hysterofiberscope-For endoscopic diagnosis within the uterus
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upp…
FDA Device · Class II · 2023-11-29 · Aizu Olympus - SmartPath to dStream for 1.5T
FDA Device · Class II · 2023-11-29 · Philips North America - BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 100…
FDA Device · Class II · 2023-11-29 · Becton Dickinson And - Alinity c Iron Reagent, Reference Number 08P3920
FDA Device · Class II · 2023-11-29 · Sentinel Ch Spa - EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box…
FDA Device · Class II · 2023-11-29 · Boston Scientific - Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replaceme…
FDA Device · Class II · 2023-11-29 · Biomet - Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscita…
FDA Device · Class II · 2023-11-29 · Sunmed Holdings - Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502
FDA Device · Class II · 2023-11-29 · Roche Diagnostics Operations - Achieva 1.5T
FDA Device · Class II · 2023-11-29 · Philips North America - Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with B…
FDA Device · Class II · 2023-11-29 · Sunmed Holdings - ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology…
FDA Device · Class II · 2023-11-29 · Leoni Cia Cable Systems - Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM111…
FDA Device · Class II · 2023-11-29 · Sunmed Holdings - Achieva 1.5T Conversion
FDA Device · Class II · 2023-11-29 · Philips North America - Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
FDA Device · Class II · 2023-11-29 · Biomet - Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resu…
FDA Device · Class II · 2023-11-29 · Sunmed Holdings - Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures wit…
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
FDA Device · Class II · 2023-11-29 · Biomet - Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
FDA Device · Class II · 2023-11-29 · Biomet - stryker Sage PrimaFit External Urine Management System for the Female Anatomy
FDA Device · Class II · 2023-11-29 · Sage Products - VariSoft infusion set, Model Number 1002830
FDA Device · Class I · 2023-11-29 · Unomedical A S - Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
FDA Device · Class II · 2023-11-29 · Biomet - Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
FDA Device · Class II · 2023-11-29 · Medtronic - Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resus…
FDA Device · Class II · 2023-11-29 · Sunmed Holdings - Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
FDA Device · Class II · 2023-11-29 · Medtronic Neuromodulation - Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resusci…
FDA Device · Class II · 2023-11-29 · Sunmed Holdings - FilmArray TORCH REF HTFA-ASY-0104
FDA Device · Class II · 2023-11-29 · Biofire Diagnostics - Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item…
FDA Device · Class II · 2023-11-29 · Biomet - Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve)
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management
FDA Device · Class II · 2023-11-29 · Aizu Olympus - IRON assay, Reference Numbers 6K95-41 and 6K95-30
FDA Device · Class II · 2023-11-29 · Sentinel Ch Spa - Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
FDA Device · Class II · 2023-11-29 · Biomet - Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult R…
FDA Device · Class II · 2023-11-29 · Sunmed Holdings - VariSoft infusion set, Model Number 1002827
FDA Device · Class I · 2023-11-29 · Unomedical A S - Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and…
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and il…
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replaceme…
FDA Device · Class II · 2023-11-29 · Biomet - Intera 1.5T Power/Pulsar
FDA Device · Class II · 2023-11-29 · Philips North America - Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult…
FDA Device · Class II · 2023-11-29 · Sunmed Holdings - Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duoden…
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct)
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V
FDA Device · Class II · 2023-11-29 · Aizu Olympus - BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Fil…
FDA Device · Class II · 2023-11-29 · Becton Dickinson And - Achieva 1.5T Initial System
FDA Device · Class II · 2023-11-29 · Philips North America - Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replaceme…
FDA Device · Class II · 2023-11-29 · Biomet - GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360…
FDA Device · Class II · 2023-11-29 · Instrumentation Laboratory - Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
FDA Device · Class II · 2023-11-29 · Biomet - VariSoft infusion set, Model Number 1002828
FDA Device · Class I · 2023-11-29 · Unomedical A S - Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T
FDA Device · Class II · 2023-11-29 · Aizu Olympus - ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology…
FDA Device · Class II · 2023-11-29 · Leoni Cia Cable Systems - AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
FDA Device · Class II · 2023-11-29 · Avanos Medical - Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
FDA Device · Class II · 2023-11-29 · Medtronic - BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 40…
FDA Device · Class II · 2023-11-29 · Becton Dickinson And - Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev
FDA Device · Class II · 2023-11-29 · Convergent Dental - Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and manag…
FDA Device · Class II · 2023-11-29 · Aizu Olympus - Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult R…
FDA Device · Class II · 2023-11-29 · Sunmed Holdings - Choleodochoscope
FDA Device · Class III · 2023-11-29 · Aizu Olympus - Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE
FDA Device · Class II · 2023-11-22 · Atrium Medical - ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
FDA Device · Class II · 2023-11-22 · Medline Industries Northfield - 24 BLOOD CULTURE KIT, REF DYNDH1632
FDA Device · Class II · 2023-11-22 · Medline Industries Northfield - LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
FDA Device · Class II · 2023-11-22 · Physio Control - LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
FDA Device · Class II · 2023-11-22 · Physio Control - Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology an…
FDA Device · Class II · 2023-11-22 · Philips North America - Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal a…
FDA Device · Class II · 2023-11-22 · Atrium Medical - BLOOD CULTURE KIT, REF DYNDH1647B
FDA Device · Class II · 2023-11-22 · Medline Industries Northfield - Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S
FDA Device · Class II · 2023-11-22 · Atrium Medical - Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
FDA Device · Class II · 2023-11-22 · Philips North America - Regard CV PK, Item Numbers a) 880289014, b) 880289015
FDA Device · Class II · 2023-11-22 · Roi Cps - LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
FDA Device · Class II · 2023-11-22 · Physio Control - LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
FDA Device · Class II · 2023-11-22 · Physio Control - Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC
FDA Device · Class II · 2023-11-22 · Atrium Medical - Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
FDA Device · Class II · 2023-11-22 · Philips North America - CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562
FDA Device · Class II · 2023-11-22 · Medline Industries Northfield - LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
FDA Device · Class II · 2023-11-22 · Physio Control - IBA Proton Therapy System - PROTEUS 235
FDA Device · Class II · 2023-11-22 · Ion Beam Applications - AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and conce…
FDA Device · Class II · 2023-11-22 · Beckman Coulter Biomedical Division
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