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.
- 2020-03-11FDA-DeviceDeroyal Industries, Inc. LafolletteClass IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-03-11FDA-DeviceDeroyal Industries, Inc. LafolletteClass IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-03-11FDA-DeviceDeroyal Industries, Inc. LafolletteClass IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-03-11FDA-DeviceDeroyal Industries, Inc. LafolletteClass IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-03-11FDA-DeviceBaxter Healthcare CorporationClass IIRevaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
- 2020-03-11FDA-DeviceMedtronic, PLCClass IIMcGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.
Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as displayed on the video screen
- 2020-03-11FDA-DeviceCareFusion 303, Inc.Class ICareFusion Alaris PCA Module, Model 8120
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
- 2020-03-11FDA-DeviceCareFusion 303, Inc.Class ICareFusion Alaris Syringe Module, Model 8110
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
- 2020-03-11FDA-DeviceCareFusion 303, Inc.Class ICareFusion Alaris Pump Module, Model 8100
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
- 2020-03-11FDA-DeviceCareFusion 303, Inc.Class ICareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS-V, 100153HS-V, 100154HS-V, 100201HS-V, 100202HS-V, 100203HS-V, 100204HS-V, 100206HS-V, 100254HS-V, 100256HS-V, 100304HS-V, 100306HS-V, 100308HS-V, 100406HS-V, 100408HS-V, and 100508HS-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular sy
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC030610-V, VFC030615-V, VFC061020-V, VFC061030-V, VFC101530-V, VFC101540-V, VFC152040-V, and VFC152060-V. Product Usage: . The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202HHTA, MV-00203HHTA, MV-00204HHTA, MV-00206HHTA, MV-00208HHTA, MV-00304HHTA, MV-00306HHTA, MV-00308HHTA, MV-00310HHTA, MV-00408HHTA, MV-00412HHTA, MV-00510HHTA, MV-00515HHTA, MV-00612HHTA, MV-00619HHTA, MV-00715HHTA, MV
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 100612CMSR-V, 100618CMSR-V, and 100721CMSR-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vas
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. Product Usage: The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V, 100510HFRM-V, 100515HFRM-V, 100519HFRM-V, 100612HFRM-V, 100619HFRM-V, 100623HFRM-V, 100715HFRM-V, 100728HFRM-V, 100817HFRM-V, 100833HFRM-V, 100931HFRM-V; 101036HFRM-V, MV-00408HHFA, MV-00510HHFA, MV-00515HHFA, and MV-00619HHFA. Product Usage: The HES is also intended for vascular occlusion of b
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVent
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100820CC-V, 100924CC-V, and 101026CC-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vascula
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451CS-V, 181652CS-V, 181859CS-V, 182065CS-V, 182263CS-V, and 182468CS-V; Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embol
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 100515CSSR-V, 100522CSSR-V, 100618CSSR-V, 100626CSSR-V, 100722CSSR-V, 100731CSSR-V, 100825CSSR-V, 100837CSSR-V, 100933CSSR-V, and 101036CSSR-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneu
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520HC-R-V and 181230HC-R-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, 100410HCSR-S-V, Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous emboli
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620HC-R-V, 100620HCSR-R-V, 100730HC-R-V, 100730HCSR-R-V, 100830HC-R-V, 100930HC-R-V, 100930HCSR-R-V, 101030HC-R-V, and 101030HCSR-R-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 100202HS3D-V, 100203HS3D-V, 100204HS3D-V, 100206HS3D-V, 100208HS3D-V, 100254HS3D-V, 100256HS3D-V, 100304HS3D-V, 100306HS3D-V, 100310HS3D-V, 100355HS3D-V, 100358HS3D-V, 100406HS3D-V, 100408HS3D-V, 100412HS3D-V, 100415HS3D-V, 100510HS3D-V, 100515HS3D-V; MV-00102HTDA, MV-00103HTDA, MV-00204HTDA,MV-0030
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMicrovention, Inc.Class IIMicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 100152H2HS-V; 100153H2HS-V; 100154H2HS-V; 100201H2HS-V; 100202H2HS-V; 100203H2HS-V; 100204H2HS-V; 100206H2HS-V, 100208H2HS-V, 100254H2HS-V, 100256H2HS-V, 100304H2HS-V; 100306H2HS-V; 100308H2HS-V; 100310H2HS-V; 100404H2HS-V; 100406H2HS-V, 100408H2HS-V, 100410H2HS-V, 100506H2HS-V, 100508H2HS-V; 100510H2H
The devices may be missing the implant coil.
- 2020-03-04FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIIGetinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
- 2020-03-04FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIIGetinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
- 2020-03-04FDA-DeviceLivaNova USA Inc.Class IIILivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
Perfusion tubing pack was packaged with the incorrect cuvette.
- 2020-03-04FDA-DeviceBiomet 3i, LLCClass IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
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