Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

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

Presence of particulates in affected devices that can be deposited into breast tissue during use.

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.

Due a design issue where the navigated array connection geometry is incorrect.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

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.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.

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.

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.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

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.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

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.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

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

The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.

Due a design issue where the navigated array connection geometry is incorrect.

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.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Tyvek bag seal issue which may compromise sterility of the kit.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

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.

Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.