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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…

The hoses may have a weak crimp on the brass connector of the hose, which could lead to a leak in propane when connected to a fuel source, posing a risk of fire and burn hazards to the user. As of November 15, 2023, the company has received 1 report…

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…

Through an internal investigation, it was identified that there is a defect in the outer packaging of the cranial access kits. This defect can cause the packaging to split without any additional forces outside of regular manufacturing and sterilization/…

Issue: On certain side-by-sides, the steering rack could fail and cause a loss of steering. Safety Risk: A loss of steering control could create the risk of a crash. Corrective Actions: Polaris advises not to drive your side-by-side until…

Ortho Cinical Diagnostics (quidelortho) has determined that some lots from coating 3598 of Vitros Eco2 Slides include carts which may contain consecutive slides that may not function as intended. These affected Vitros Eco2 slides (potentially…

 Solution bags may be leaking in affected lots.

Solution bags may be leaking in affected lots.

 Solution bags may be leaking in affected lots.