Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781075
TELEFLEX
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Medtronic Neuromodulation
Class I - Dangerous
A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080
TELEFLEX
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
Megadyne Medical Products
Class I - Dangerous
Firm has received reports of patient burns in surgical procedures where device was used.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780055
TELEFLEX
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090
TELEFLEX
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.