Merit Medical Systems recalled 864 units of its Custom Waste Management Kit Vascular Tray on December 4, 2025. The handle of the inflation device may detach from the syringe during use, posing a serious risk to patients. Healthcare providers should stop using the device immediately and follow recall instructions.
Inflation device handle may detach from the syringe during procedure.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Merit Medical Systems, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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The recalled product is the Custom Waste Management Kit Vascular Tray, REF: K10T-05261. It was distributed worldwide, including all U.S. states and several countries. The model is identified by UDI: 00884450320297.
The inflation device handle may detach from the syringe during procedures. This defect can lead to serious complications for patients being treated.
No specific incidents or injuries have been reported thus far. However, the potential for serious consequences exists if the device fails during use.
Stop using the device immediately. Contact Merit Medical Systems, Inc. or your healthcare provider for detailed instructions on the recall.
For more information, reach out to Merit Medical Systems, Inc. via email or visit their website. Additional details are available at the FDA recall page.
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