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In 2013, ISTODAX (romidepsin) was authorized under a Notice of Compliance with conditions (NOC/c) for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one…

Health Canada is advising the public that Gilead Sciences Incorporated recalled two lots (032168 and 033357) of the cystic fibrosis drug Cayston (aztreonam) (DIN 02329840) on March 1, 2023, due to the potential of cracked glass vials in those lots, which…

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…

Thermo scientific™ Hp StaR™ lateral flow kits are failing to meet IFU criteria with multiple strip giving false positive results with known negative samples and also false positive result on substrate diluent. Recall start date: March 10, 2023

Canada is experiencing a shortage of nitroglycerin 0.4 MG/ACT sprays due to supply issues with the raw materials used to make the sprays as well as an increase in demand. Nitroglycerin sublingual spray is applied under the tongue and is used to treat…

While conducting safety disk testing, expired tubing was used on the test fixture equipment between April 01, 2022 and July 31, 2022. when using the obsoleted, and expired catheter extender tube, 0004-00-0033-01 during the static inflate/deflate test…

Health Canada is warning parents and caregivers about two unauthorized children's syrups for thinning mucus, Robikids and Solmux, seized from Kamshoppe, which advertised the products on Facebook. Both products are labelled to contain carbocisteine, a…

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 investigational testing of the Habib™ Catheter with the ERBE VIO 3 generator (compatible 3rd party device), an issue with the generator setting in the Habib™ IFU (50738103) was identified. From the results of this testing, it was…

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 (…

The recall is being done because the device does not meet the requirements of the MDR. Specifically, the devices implanted are not on the device system's active license 104252. Recall start date: March 1, 2023

Zimmer Biomet is conducting a medical device correction to update the compatibility matrix as referred to in the instructions for use (IFU) for the CoCr Femoral Head XS. The update is to remove the compatibility with the Epsilon Durasul Constrained …