Merit Medical Systems recalled 18,897 custom inflation kits on December 4, 2025. The inflation device handle may detach from the syringe during use, posing a risk of injury. Healthcare providers and patients should stop using the device immediately.
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 Merit Medical Custom Inflation Kit is used in various medical procedures to inflate devices such as balloons or stents. Patients and healthcare providers often rely on these kits for effective treatment during minimally invasive surgeries.
The risk arises from the potential detachment of the inflation device handle from the syringe, which can disrupt medical procedures and lead to complications. This defect affects the device's reliability during critical moments.
This recall is not part of a broader industry pattern.
The recall poses significant safety concerns for healthcare providers and patients, requiring immediate action to avoid potential injuries.
Model numbers can be found on the packaging and the device itself, typically near the barcode or product label.
Allow 4-6 weeks for the refund or replacement process once the recall instructions are followed.
Keep a record of your purchase receipt, model number, and any correspondence with the manufacturer regarding the recall.
The affected models include K05-00761F, K05-01717B, K05-02080D, K05-02090C, K05-02221, and several others. The kits were distributed worldwide, including all U.S. states and many countries. The recall includes a total of 18,897 units.
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