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Manufacturer has received reports of events related to airway obstruction while using the impacted device. Not following the instructions for use (IFU) and over-inflating the cuff increases intra-cuff pressure, which can cause the silicone cuff to extend…

Dräger has become aware of one case in which an obstructed Breathing System Filter Safestar 55 was used on a patient during anesthesia. The patient reportedly became hypoxic and had to be reanimated. If an obstructed filter is used on a patient,…

The proximal marker on devices from these lots may separate from the device. A dislodged marker may require additional intervention, including unplanned additional coronary intervention, or surgery. To date Abbott has received 5 complaints related to…

Avanos medical is conducting a voluntary field correction for the Cortrak* 2 Enteral Access System (Eas) because modifications to the labeling of the device have been initiated. Reports of injuries and patient deaths related to misplacement of…

Bias flow selection for NO system usage is missing from the user interface of Fabian HFOi Ventilators following incorrect selection of device configuration during a software update. This is caused by human error and there is no defect in the device or…

Smiths Medical became aware of eight (8) issues-(identified below) that can potentially occur that may impact therapy delivery in specific Medfusion 3500 and 4000 syringe infusion pumps. 1. Primary Audible Alarm (PAA) 2. Unanticipated depleted battery…

Potential for injury if the MR system is incorrectly deinstalled. Recall start date: Mar 10, 2022

Potential for injury if the MR system is incorrectly deinstalled. Recall start date: Mar 10, 2022

Potential for injury if the Mr system is incorrectly deinstalled. Recall start date: Mar 10, 2022

BBMI has identified through complaints the potential for fluid leakage or low fill volume of the respective containers of 0.9% sodium chloride injection USP 250ml [din : 01924303, lot no : l8002]. There is also the potential for smaller micro-leaks which…

The recall is being initiated due to a software defect that is triggered by disconnecting / connecting an USB device, causing a restart of the infinity central station and a temporary loss of central monitoring. Recall start date: Mar 8, 2022

During verification testing, a non-conformance was detected. Failure mode was uncontrolled leakage of glue from the distal tip of the Fix8 open (FX002) device. Recall start date: Feb 3, 2022

Hillrom received four (4) complaints between 29-Sep-2020 and 09-Apr-2021 of the Slingbar 450 becoming detached from the upper bracket of the Slingbar attachment on Liko M230 Mobile Lifts. The Slingbar is attached to the lifting arm through two brackets.…

Ventilation stops during clinical use, with waveforms and parameters frozen (not updated). a continuous audible/visual high priority alarm for technical failure 305 is generated. ventilation is suspended until unit is rebooted/replaced. Recall start…

All ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination. Multiple products could be affected by manufacturing issues associated with the company's ultrasound gel (such as inappropriate testing of finished product,…