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 Merit Medical Custom Procedure Kit is used in various medical procedures requiring inflation. Healthcare providers buy these kits for their essential role in patient treatment.
The handle of the inflation device can detach from the syringe, which could lead to complications during procedures. This defect puts patients at risk of receiving inadequate or improper treatment.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must stop using the affected kits, which may disrupt medical procedures and require alternative solutions.
The reference numbers and lot numbers are typically printed on the kit packaging and product labeling.
Expect a refund or replacement processing timeline of approximately 4-6 weeks after the request is submitted.
Keep all receipts, correspondence with the manufacturer, and any photos of the product as evidence for your records.
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.
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