Medical device recalls

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

Potential for incomplete seal on header bag.

Potential for incomplete seal on header bag.

Potential for incomplete seal on header bag.

Potential for incomplete seal on header bag.

Potential for incomplete seal on header bag.

The devices may have a misaligned thickness control bar.

The devices may have a misaligned thickness control bar.

The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.

Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.

Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Screw may loosen or fallout of Hemodialysis system

There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.