Medical device recalls

39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.

2019-08-21FDA-DeviceBioPro, Inc.Class II
Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Manufacturing flaw in the sterile barrier system
2019-08-21FDA-DeviceBioPro, Inc.Class II
Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Manufacturing flaw in the sterile barrier system
2019-08-21FDA-DeviceBioPro, Inc.Class II
K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Manufacturing flaw in the sterile barrier system
2019-08-21FDA-DeviceBioPro, Inc.Class II
K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Manufacturing flaw in the sterile barrier system
2019-08-21FDA-DeviceBioPro, Inc.Class II
K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Manufacturing flaw in the sterile barrier system
2019-08-21FDA-DeviceBioPro, Inc.Class II
K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Manufacturing flaw in the sterile barrier system
2019-08-21FDA-DeviceBioPro, Inc.Class II
K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Manufacturing flaw in the sterile barrier system
2019-08-21FDA-DeviceBioPro, Inc.Class II
K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Manufacturing flaw in the sterile barrier system
2019-08-21FDA-DeviceBioPro, Inc.Class II
K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine.
Manufacturing flaw in the sterile barrier system
2019-08-21FDA-DeviceSantanello Surgical LLCClass II
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
Lack of package integrity may compromise sterility
2019-08-21FDA-DeviceZimmer Biomet, Inc.Class II
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815
Cleaning processes potentially being ineffective
2019-08-21FDA-DeviceZimmer Biomet, Inc.Class II
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
Cleaning processes potentially being ineffective
2019-08-21FDA-DeviceZimmer Biomet, Inc.Class II
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
Cleaning processes potentially being ineffective
2019-08-21FDA-DeviceZimmer Biomet, Inc.Class II
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
Cleaning processes potentially being ineffective
2019-08-21FDA-DeviceZimmer Biomet, Inc.Class II
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
Cleaning processes potentially being ineffective
2019-08-21FDA-DeviceZimmer Biomet, Inc.Class II
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
Cleaning processes potentially being ineffective
2019-08-21FDA-DeviceElekta, Inc.Class II
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Potential for iGUIDE to incorrectly monitor the 3D position.
2019-08-21FDA-DeviceMedline Industries IncClass I
Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion code 110931) contained inside kits DYNJ52509A and DYNJ52510A. Product Usage: The Centurion Primary Set Pack and Primary Warmer Pack Convenience Kit helps continuously or intermittently deliver fluids, medications, blood and blood products to adult, pediatric or neonatal patients.
This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue with the consistency of the inner lumen thickness of the silicone tubing segment which directly impacts amount of occlusion force necessary to fully seal the tube. This defect prevents the pump from complete occlusion and results in the potential for over-infusion of drug product into the patient.
2019-08-21FDA-DeviceMedline Industries IncClass I
Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow Disposable Cartridges contain a heating element that is used to help raise or maintain a patient's body temperature.
The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Use of the BD Alaris Pump Infusion Set may lead to serious adverse events for patients due to the incomplete occlusion caused by variation in tubing wall thickness.
2019-08-21FDA-DeviceFenwal IncClass I
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigilant Drug Lib Agilia is a software application running on a computer and intended to configure and generate multiple device configurations, drug libraries, care areas and data sets that can then be uploaded to the Volum
The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib
2019-08-21FDA-DeviceFenwal IncClass I
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, co
The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib
2019-08-14FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class II
Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.
Negative Bias with Lot EA9227.
2019-08-14FDA-DeviceIntellijoint Surgical, Inc.Class II
Workstation, G2, Configured (P/N 000-0241)
Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. To date, Intellijoint has distributed, 15-inch MacBook Pros which are the Workstation component (affected P/N 000-0241) in the Intellijoint HIP System.
2019-08-14FDA-DeviceOpternative IncClass II
The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This online portion of the Visibly Vision Test Solution is used to measure vision refraction.
Lack of 510K clearance
2019-08-14FDA-DeviceMicroAire Surgical Instruments, LLCClass II
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
There was a higher than normal incidence rate of the blade not retracting when tightening.
2019-08-14FDA-DeviceROi Consolidated Service Center (CSC)Class II
Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.
2019-08-14FDA-DeviceROi Consolidated Service Center (CSC)Class II
Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.
2019-08-14FDA-DeviceIdeal Implant IncorporatedClass II
IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.
The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
2019-08-14FDA-DeviceRa Medical Systems IncClass II
The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and
Lasers/Catheters did not calibrate during set-up prior to use.
2019-08-14FDA-DeviceMedical Components, Inc dba MedCompClass II
14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

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