Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
All Recalls
95,025 total recalls in our database
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
Abbott Laboratories Inc. (St Jude Medical)
🏥 Medical Devices Class I - Dangerous
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Abbott Laboratories Inc. (St Jude Medical)
🏥 Medical Devices Class I - Dangerous
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32
Skytron, Div. The KMW Group
🏥 Medical Devices Class I - Dangerous
Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or staff
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Radiometer Medical ApS
🏥 Medical Devices Class I - Dangerous
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
🏥 Medical Devices Class I - Dangerous
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
Abbott Laboratories Inc. (St Jude Medical)
🏥 Medical Devices Class I - Dangerous
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
🏥 Medical Devices Class I - Dangerous
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld