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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…

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…

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/…

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…

Philips has identified a potential safety issue with the Philips Allura and Azurion product families having monoplane fixed ceiling mounted systems. The ceiling mounted l-arm contains a rotation cover that may potentially be susceptible to falling if a…

XPRSTREPA-CE-10 kits packaged with defective pipettes may cause failure to dispense an adequate volume of the patient sample to the test cartridge. If there is inadequate volume of patient sample being tested, the customer may receive an 'invalid' or 'no…

The outer jacket of the tank hose assembly does not have the specified pin perforations due to supplier oversight. Gas could get trapped on non-pin perforated hoses under the outer jacketing of the hose, forming a distension. Recall start date:…

BD has identified internally that the infusion sets contain di(2-ethylhexyl) phthalate (DEHP) and have not been labeled accordingly. Recall start date: November 13, 2023

Cardinal Health was recently informed of a medical device recall concerning the Sage PrimaFit® external urine management for the female anatomy as a small percentage of devices in three lots (93667, 93614, 93613) may contain a tape with natural rubber…

Medtronic is notifying customers of a population of LINQ II Insertable Cardiac Monitors (ICM) that underwent a manufacturing process that may allow for moisture to impact electrode performance. This may create the potential for amplified noise and/or…

When the push-start board was manufactured, a capacitor was incorrectly mounted (polarity). This can lead to overheating if the device is running for min. 60 minutes and then restarted. Delay for restart and treatment.  Recall start date:…