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Smiths Medical has identified a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the device's o-ring may be oversized affecting seal integrity. Recall Start Date: November 9, 2023

Baxter is issuing an important product information letter to communicate that the cardiovascular surgery marketing brochure (Ref ca-as32-210022 (English) and ca-as32-220004 (French)) that was distributed for the products listed above contains inaccurate…

It has been determined that the terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed. Because of this, the cable became disconnected, and arcing occurred. Melting of the cable due to…

Baxter is issuing an important product information letter to communicate that the cardiovascular surgery marketing brochure (Ref ca-as32-210022 (English) and ca-as32-220004 (French)) that was distributed for the products listed above contains inaccurate…

Baxter is issuing an important product information letter to communicate that the cardiovascular surgery marketing brochure (Ref ca-as32-210022 (English) and ca-as32-220004 (French)) that was distributed for the products listed above contains inaccurate…

Philips has been informed of an event in which the structural integrity of the Panorama 1.0T HFO system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. During a quench, a large amount of helium…

Health Canada is warning people with diabetes and parents/caregivers of people with diabetes that various social media and online retail platforms are promoting unauthorized blood glucose-reading smartwatches. These devices have not been assessed for…

Product sold without market authorization (DIN) Canada. Product contains undeclared pancreatin that is listed on the Prescription Drug List (provides more than 20 000 USP units of lipase activity/dose).

BD continues to receive complaints for the product regarding mismatch between the coaxial and the needle in mission kit devices.  Based on the event reported, the internal diameter of the coaxial cannula may be smaller or larger than the external…

Medtronic has received 87 complaints as of October 5th, 2023 indicating potential health hazards of degraded or loss of functionality of the device with specific lots. The potential hazards can cause unintended extubation, a delay or a cancelation of the…

Leica Biosystems became aware, through post market surveillance, of an issue regarding poorly processed and/or damaged biopsy tissue specimens on the Histocore Pegasus / Histocore Pegasus Plus, resulting from incorrect assignment of the carryover value…

Maquet Cardiopulmonary Gmbh received customer complaints for custom tubing packs (CTP) reporting the perforation of the Tyvek, the upper part of the sterile barrier of the packaging. Upon further investigation, the internal components set were found to…

Affected lot may contain over-sized tablets.

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 surgical drill can result in a hole being drilled 1 mm…

Olympus has identified a total of 1003 complaints, including 372 adverse events (since September 2020 to August 2023) related to pink or green coloration of the image, including cases with reported delays of treatments and/or prolonged surgery. Olympus…