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Finished 1057 sets made with a occluded air pathway will trigger the inlet occlusion alarm of the pump and stop delivery of medication until the inlet occlusion is resolved by replacement of the 1057 IV set. The pump detects the inlet occlusion functions…

Philips Azurion System may unexpectedly lose X-ray functionality. Due to a software issue, a mechanism that is present in the system to manage the number and size of log trace files does not function properly. Without this mechanism, the log trace files…

Tip of the catheter, which is an indwelling component of the Zenith Branch Iliac Endovascular (ZBIS) and the Bifurcated Iliac sidebranch CMD can split / break during device preparation or during the endovascular procedure. This recall is specific to all…

Abbott sent a customer communication on 2023-02-27 to raise awareness around the potential for early structural valve deterioration (SVD), a known risk associated with these devices, compared to other valves and to provide reminders and considerations…

A portion of the products in the specific lots identified above were packaged and marked (i.e., laser etched) incorrectly, specifically: catalog no. gl11, lot number d22xbb may be marked (i.e., laser etched), packaged, and labeled as catalog no. gl31,…

BVI has received two complaints from customers that identified an end of the sterile pouch of model #40430 PVA Ultracell Medical Sponges was not sealed. Two lots (21m3820 and 21l3403) have been identified as affected by this failure mode. BVI has…

Philips Respironics has discovered that accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FioO2 sensor may indicate a value…

Beckman Coulter has determined that Access Free T3 reagent lot 233968 included an insufficient concentration of blocking reagent. Patient samples tested with Access Free T3 reagent lot 233968 may demonstrate repeatable falsely elevated results, which are…

Cordis is recalling specific lots of ANGIOGUARD™ RX / XP Emboli Capture Guidewire System, Cordis has identified that there is a potential for separation of the ANGIOGUARD™ RX / XP delivery system and capture sheath. The potential impacts of separation…

Steris identified through customer complaints that the LB53 light handle covers may separate from the light handle (detach and fall off) during use. Through additional investigation Steris has determined the issue to be associated with the specific lots…

During a ventilation sequence, the user started the "100% O2" function. This function lasts for two minutes but can be interrupted by pressing the 100% O2 key. Note: after the 100% O2 function has been used, the FiO2 setpoint originally entered is…

Two potential Hamilton-C6 Ventilator malfunctions detected following an inspection by Hamilton Medical Ag.:  Malfunction 1: Safety ventilation can be triggered by switching to an adaptive mode. Malfunction 2: The display can be restarted by…

Some lot numbers of collection tubes Vacuette * K2 EDTA have experienced an issue of clotting. This was caused by insufficient amounts of EDTA additive sprayed in the tubes. Recall start date: March 7, 2023

During our global market surveillance activities, we have become aware of cases in which the software on the Infinity® Central Station drops peaks on narrow waveforms causing the Infinity® M300 to fail the requirements of the standard IEC 60601-2-27.…

Hole in the adaptor strap may be larger than the river head mounted to hold the trap in place.  Strap could detaches from the portable scale adaptor during a patient transfer with the lifting equipment. It could lead to their fall, potentially…