Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) ...
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Elec...
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYN...
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Spectral CT; Product Code (REF): 728333;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Ki...
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Ca...
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monit...
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software ...
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-0...
Due a design issue where the navigated array connection geometry is incorrect.
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU ...
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Moni...
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: B...
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewi...
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Softwa...
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DY...
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monit...
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate...
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE K...
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Tyvek bag seal issue which may compromise sterility of the kit.
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-...
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYND...
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.