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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…

Radiometer has become aware that there is a problem relating to the Aqure System (stand alone software system) used in combination with the third party device Lumiradx that may result in patient mix-up. Currently there are no customers in Canada using…

During a specific servicing activity, if the wrong screws are removed by the service personnel without the appropriate table supports in place, there is the potential for the table to drop. Recall start date: June 6, 2022…

This recall is being initiated to notify customers that BD has identified internally through a product review that the BD Bodyguard™ Microsets do not currently have the evidence to support compliance with ethylene oxide (eo) residual level requirements (…

Laborie became aware of the damaged packaging through the complaint process. A complaint case was issued in response to a customer complaint involving a small hole found in the film of the sterile barrier of the Injetak needle packaging (dis201). Further…

An increase in reports in which a loose instrument carriage is observed on the universal side manipulator (usm) or the instrument arm of the Da Vinci X and Xi systems.  The loose instrument carriage is an outcome of a linear rail component being out…

Philips has identified through an internal investigation that Smartperfusion and 2D perfusion have technical issues related to the way the perfusion signal is generated and processed, which may lead to inaccurate presentations of time density curves and…

Safety issues in Centricity High Acuity Critical Care (CHA CC) and Centricity High Acuity Anesthesia (CHA A). Recall start date: October 02, 2022

The affected products were manufactured using unvalidated materials that can result in unsealed packaging for the individual syringes. Recall start date: February 3, 2023

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.  Recall start date: February 01, 2023

Through ongoing internal testing, Baxter Corporation has observed isolated incident of over infusion on the Novum IQ LVP infusion pump during test runs at 0.1 ml/hr after 40 hours of continuous infusion within the 96-hour set change interval. Baxter…

Cardinal Health has initiated a medical device correction for specific production lots of the Cardinal Health™ Jackson-Pratt™ channel drains. The recall is being issued due to various performance issues including lack of radiopacity in wound drains, dull…

The catheter repair adhesive used to attach the repair segment to the original catheter is hardened/coagulated (unusable). Recall start date: January 4, 2023

Medline Industries, LP is recalling custom procedure packs containing medtronic non-absorbable sutures due to a manufacturing error in the packaging of the sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile barrier…

Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health™ Channel wound drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound…