Merit Medical recalls Custom Manifold Kits with specific model numbers due to high pressure tubing that may relax over time, potentially trapping air in the patient's line.
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
Merit Medical is recalling certain Custom Manifold Kits because high pressure tubing can relax over time, creating a void that may trap air in the patient's line. This could introduce air into the patient's system during use.
The high pressure tubing in the kit may relax over time, causing it to partially separate from the connector. This creates a void that can trap air in the patient's line, which may then be introduced into the patient's system during use.
Patients using the recalled Custom Manifold Kits for medical purposes are most at risk. The recall affects specific model numbers and serial lots sold through medical suppliers.
Check for model numbers K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, or K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B. The product was sold with specific expiration dates and serial numbers listed in the recall notice.
Identify the model number on your Custom Manifold Kit to see if it matches the recalled list.
Reach out to Merit Medical Systems for guidance on next steps if your product is affected.
The recall affects Custom Manifold Kits with model numbers K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, and K09T-12020D, K09T-12275B.
Check the model number on your kit against the list provided in the recall notice. Also, verify the serial number and expiration date listed in the product's documentation.
Contact Merit Medical Systems directly for specific instructions on next steps if your product is affected.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2295-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-2295-2025 from Merit Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
