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Teleflex has initiated a voluntary recall due to reports of disconnection of the 15mm connector from the endotracheal tube (et tube) for the affected products. Recall start date: May 26, 2023

Baxter Corporation is issuing an urgent medical device correction due to a defect in the Dose IQ Safety Software used with Novum IQ Large Volume Pump, resulting in an invalid initial setting for the air-in-line threshold for any new care area created in…

During the course of global market surveillance activities, the manufacturer has become aware of cases where Oxylog 3000 Plus emergency and transport ventilators have stopped ventilation due to empty batteries despite being reconnected to the mains power…

Medtronic has identified a rare potential for reduced or no-energy output during high voltage therapy in Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured with a specific (glassed)…

During the course of global market surveillance activities, the manufaturer has become aware of cases in which the resuscitaire infant radiant warmer with the optional scale could display inaccurate weight values. There is a potential for the mattress…

Affected lot may contain the presence of particles.

Baxter Corportation is issuing a recall for certain lots of the Minicap. These devices are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals.  Baxter is expanding the urgent medical…

Auto-injectors may be malfunctioning in affected lots.

Solution bags may be leaking in affected lots.

During global market surveillance activities, manufacturer became aware of cases in which glued connections of the breathing circuits  became loose either before or during the ventilation process resulting in partial or complete detachment of…

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…

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.…

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

Vials may be cracked in affected lots.

It was identified by Medtronic that an incorrect type of titanium was used for the manufacturing of subcomponents of multi-axial screws that are for use as part of the Infinity oct system. This incorrect material reduces the clamping strength of the…