Merit Medical Systems recalled multiple Custom Procedure Kits on December 4, 2025, due to a risk of the inflation device handle detaching from the syringe during use. The recall affects several reference numbers sold worldwide, including in the U.S. and various international markets.
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 recall includes Custom Procedure Kits with reference numbers K12T-04270A, K12T-07956, and K12T-10922B. These kits were distributed worldwide, including in all U.S. states and numerous countries. Specific lot numbers are listed for each reference number.
The inflation device handle may detach from the syringe during procedures, posing a risk of injury to patients. This defect could lead to potential complications during medical procedures.
As of now, no specific incidents or injuries have been reported related to this recall. However, the potential for injury is considered high due to the nature of the defect.
Patients and healthcare providers should stop using the affected kits immediately. Contact Merit Medical Systems for guidance on returning the product and obtaining instructions.
For more information, contact Merit Medical Systems, Inc. via email. Detailed recall instructions are also available on the FDA website.
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