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Affected lot may contain heavy metal (arsenic) above the acceptable limit.

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…

Currently, the Hemospray instructions for use states "Potential complications: when spraying in the retroflexed position, Hemospray powder may adhere to the outside of the endoscope. This may result in difficulty repositioning / removing the endoscope,…

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…

Product sold without market authorization (DIN) in Canada.

This notice is to inform you that Bio-Rad Laboratories is initiating a recall due to a quality issue detected during an investigation into a positive agglutination test for the negative control serum provided in the Pastorex Toxo kit (cat #72724), for…

Bio-Rad Laboratories is initiating a recall due to a confirmed quality anomaly for Platelia  aspergillus IgG test (cat #62783), for lot 2l0039 (expiry date: 2024/04/15). The current lot 2l0039 shows a decrease of Optical Density (OD) of all…

During extended operation of the MX40 with the PIC iX, the DHCP (dynamic host configuration protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the pic ix, a new IP address will be…

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 an update of data used in a library shipped with Exoplan or made available on the download portal of Exocad, it was found that the use of a specific combination of an implant, sleeve and drill in a surgical kit can result in a hole being drilled…

Some of the tubes have no gel. Recall start date: May 12, 2023

TheraHoney wound gel is being recalled after a sterility dose audit failure by the manufacturer. Certain lot numbers are affected. usage of non-sterile gel on open wounds or compromised skin could increase infection risk. Recall start date: May 16,…

Olympus has become aware of increased complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients.…

The ceiling tube support for the above device consists of an x-ray tube support pull-up section and an x-ray tube support section to which an x-ray tube assembly is mounted, and the tube holding section is secured to the column of the x-ray tube support…