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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

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…

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.…

This notice concerns issues with DICOM export from the virtual simulation module and issues with import of virtual simulation plans in Raystation, Rayplan 10a, 10b & 11b a including service packs. Recall start date: February 17, 2023

 The Loss on Drying is out of specification in the affected lot.  

Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Recall start date: March 1, 2023

Olympus has received complaints that the clip did not come out of the tube sheath during the procedure. investigation by Olympus confirmed the tube sheath is longer than specifications which prevents the clip from being extended. Absence of treatment,…

Maquet Cardiopulmonary GmbH determined two trends for complaints regarding the Heater Cooler Unit HCU 40: degraded internal drain hoses and leaking vacuum valves. This recall will inform users, and give instructions to replace affected parts during next…