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Surestrips Covid-19 Antigen Tests are not authorized for sale in Canada as they were re-packaged into single tests and re-labelled without authorization by the manufacturers listed on the label (i.e. Artron Laboratories Inc.).  Recall start date…

Pump thrombosis caused by weld defect that allowed moisture into the center post and corroded the magnets that keep the impeller rotating concentrically. Recall start date: April 26, 2022

Mold was found in lot Y591676 of the product. Two species of mold were identified that could pose a potential health risk to users. Recall start date: May 3, 2022

Cook Medical identified during manufacturing that an unintended small stainless-steel cannula may be contained in the loading cartridge of these devices. This loading cartridge is manufactured by an external supplier. Recall start date: May 6, 2022

Avance Cs2, Avance Cs2 pro anesthesia devices and field replacement batteries for Avance Cs2, Avance Cs2 pro, Avance, Amingo, Aespire View - a potential battery issue can result in premature shutdown of the anesthesia device in situations where ac mains…

Cardinal Health was recently informed of a field action correction from Becton Dickinson (bd) concerning the manometer bottom assembly. The correction is being issued due to complaints and mating issues from the manometer.…

An end user site attempted to perform QC on a single test using multiple QC kits. The QC module was not designed to support testing of multiple QC kits for a single test, and it is required that all QC samples used to validate a test are contained in a…

Maquet S.A. received customer complaints regarding a paint chipping issue on the component (reference ARD568801164) located on the fork of the Volista Standop SF & DF cupolas. Recall start date: May 16, 2022

Statistical analysis indicates that with increasing operation time of the HU 35, the probability of leakage within its expected service life of 10 years increases due to material degradation of the tank fittings. Tank fittings and the screw cap of the…

Surestrips Rapid Response Covid-19 Antigen Rapid Test Device are not authorized for sale in Canada as they were re-packaged into single tests and re-labelled without authorization by the manufacturers listed on the label (i.e.…

Abbott has confirmed reports of mechanical locking, stent deployment, and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent. To reduce occurrences of deployment failures and…

The Pill Splitter lid, which houses a blade, may come unhinged from the base.  Recall start date: May 26, 2022.

Label does not meet Health Canada requirements

Radiometer has become aware of a potential issue with abl800 basic and abl8xx flex analyzers with software versions below v6.19 mr2 and configured to report cna+. We have received sporadic incidents of positive and negative…

Macopharma noticed, since the beginning of 2022, an increasing rate of failed leucodepletion results of devices containing lcrd2 filters, the frequency is currently between 0.0001%-0.08% depending on the customer, to breakages…