Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 97 of 548
FDA Devices Moderate Nov 29, 2023
Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitato…
SunMed Holdings, LLC
FDA Devices Moderate Nov 29, 2023
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
Convergent Dental
FDA Devices Moderate Nov 29, 2023
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 p…
Roche Diagnostics Operations, Inc.
FDA Devices Moderate Nov 29, 2023
DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic inju…
Musculoskeletal Transplant Foundation, Inc.
FDA Devices Moderate Nov 29, 2023
SmartPath to dStream for 1.5T
Philips North America Llc
FDA Devices Moderate Nov 29, 2023
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07…
Becton Dickinson & Company
FDA Devices Moderate Nov 29, 2023
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management…
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Sentinel CH SpA
FDA Devices Moderate Nov 29, 2023
Ingenia 1.5T CX
Philips North America Llc
FDA Devices Moderate Nov 29, 2023
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF…
SunMed Holdings, LLC
FDA Devices Moderate Nov 29, 2023
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radio…
LEONI CIA CABLE SYSTEMS
FDA Devices Moderate Nov 29, 2023
Achieva 1.5T
Philips North America Llc
FDA Devices Moderate Nov 29, 2023
Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number:…
Biomet, Inc.
FDA Devices Moderate Nov 29, 2023
BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 P…
Becton Dickinson & Company
FDA Devices Moderate Nov 29, 2023
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-…
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator R…
SunMed Holdings, LLC
FDA Devices Moderate Nov 29, 2023
Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbe…
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Achieva 1.5T Initial System
Philips North America Llc
FDA Devices Moderate Nov 29, 2023
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 29, 2023
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Res…
SunMed Holdings, LLC
FDA Devices Critical Nov 29, 2023
VariSoft infusion set, Model Number 1002827
Unomedical A/S
FDA Devices Moderate Nov 29, 2023
Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and sm…
Aizu Olympus Co., Ltd.
FDA Devices Moderate Nov 22, 2023
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Atrium Medical Corporation
FDA Devices Moderate Nov 22, 2023
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Philips North America
FDA Devices Moderate Nov 22, 2023
LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Physio-Control, Inc.
FDA Devices Moderate Nov 22, 2023
LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
Physio-Control, Inc.
FDA Devices Moderate Nov 22, 2023
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
Philips North America Llc
FDA Devices Moderate Nov 22, 2023
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
Physio-Control, Inc.
FDA Devices Moderate Nov 22, 2023
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
Philips North America Llc
FDA Devices Moderate Nov 22, 2023
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
ROi CPS LLC
FDA Devices Moderate Nov 22, 2023
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Microbiologics Inc
FDA Devices Moderate Nov 22, 2023
Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,…
Atrium Medical Corporation
FDA Devices Moderate Nov 22, 2023
LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
Physio-Control, Inc.
FDA Devices Moderate Nov 22, 2023
ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Nov 22, 2023
PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Nov 22, 2023
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
Physio-Control, Inc.
FDA Devices Moderate Nov 22, 2023
BLOOD CULTURE KIT, REF DYNDH1647B
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Nov 22, 2023
Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OAS…
Atrium Medical Corporation
FDA Devices Moderate Nov 22, 2023
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Philips North America
FDA Devices Moderate Nov 22, 2023
LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Physio-Control, Inc.
FDA Devices Moderate Nov 22, 2023
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Physio-Control, Inc.
FDA Devices Moderate Nov 22, 2023
Mobilett Mira wireless (VA20) mobile x-ray system(s)
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Nov 22, 2023
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. …
Atrium Medical Corporation
CPSC Moderate Nov 22, 2023
Lenovo Recalls USB-C Laptop Power Banks Due to Fire Hazard
FDA Devices Moderate Nov 15, 2023
DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
Philips North America Llc
FDA Devices Critical Nov 15, 2023
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Olympus Corporation of the Americas
FDA Devices Moderate Nov 15, 2023
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Pulmonx, Corp.