Merit Medical recalls Custom Manifold Kit REF K09-132: Handle may detach during procedures. Affected units have specific UDI and lot numbers. Stop using immediately to prevent injury.
Inflation device handle may detach from the syringe during procedure.
Merit Medical is recalling a Custom Manifold Kit because its inflation handle might detach during medical procedures. This could lead to injury if the handle separates while in use.
The inflation handle can detach from the syringe during medical procedures. If it separates while in use, it may cause injury to the patient or healthcare provider.
Healthcare professionals using the Custom Manifold Kit for medical procedures are most at risk. Patients receiving care with this kit could be affected if the handle detaches.
Check for the product name 'Custom Manifold Kit' with reference number K09-13203A. Affected units have specific UDI numbers: 00884450479964 and lot numbers H2671718 through H3297407.
Discontinue use of the Custom Manifold Kit if it has the reference number K09-13203A and the listed UDI or lot numbers.
The recalled kit has reference number K09-13203A.
Check the UDI number (00884450479964) and lot numbers (H2671718 through H3297407) on your kit.
The recall record does not specify a return process.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1127-2026 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-1127-2026 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.
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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.
