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Ortho™ Sera Papain is used to enhance reactivity of Ortho™ Sera red blood cell antigen typing reagents and red blood cells when used in in-vitro immunohematology assays. Through a customer complaint investigation, the reactivity of Ortho™ Sera Papain of…

Affected lot(s) may contain the presence of Burkholderia contamination. 

Baxter Corporation is issuing an urgent medical device recall for the Allen Advance Chest Support to inform customers of the potential for the device to crack where the chest base and prone supports attach to the carbon fiber operating room (or) table…

Stryker has determined that size 11 (11mm) height peek Ogival Interbody Cage (OIC) was incorrectly laser marked as having a size 10 (10mm) height. Recall start date: May 19, 2023

Affected lots are incorrectly labelled for use in the subpopulation that is less than 4 years of age.

The dextrose content is out of specification in the affected lot.

Health Canada advised that the Philaser Type 2.0 device is considered a class III medical device and requires a licence.  The Philaser Type 2.0 device is not currently licensed, so we have stopped sales and advertisement of the Philaser Type 2.0…

Presence of Sorafenib in affected lots.

Product sold without market authorization (DIN) in Canada.

Through design and development work, Max Mobility has identified a software issue with the application. When multiple processes are running on the watch's central processing unit, the application may crash unexpectedly. If this happens, the motor on the…

During the transportation of the product (only one box) from McKesson Canada to the customer, the vehicle was involved in an accident thereby exposing the products to external freezing weather conditions as low as -16°c for approximately 2 days. Due to a…

Stryker has determined that the affected pad-paks may be rendered inoperable due to depleted battery cells. As a result, the affected pad-paks could potentially fail to power on the device if needed for use. Recall start date: May 3, 2023

The attachment pin and lock can wear down faster than expected in certain circumstances. Faster wear can result in the potential for the pin to disengage from the lock, leading to loss of suspension, potentially leading to an injury. Recall start date…

An impurity is out of specification in the affected lot.

The new software version VC20G provides latest cybersecurity updates and improvements in the following categories: - Improves overall system stability - Improves dicom connectivity - Improves biopsy workflow Specifically, the new software version…