Merit Medical recalls Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque Device due to holes in the Tyvek sterile barrier that could compromise infection control during medical procedures.
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Merit Medical is recalling its Monarch Inflation Device MAP 112 to prevent holes in the Tyvek sterile barrier. This could allow contaminants to enter during medical procedures, risking infection for patients.
The device's Tyvek sterile barrier has manufacturing defects causing holes. These holes could allow contaminants to enter the sterile field during medical procedures, potentially leading to infections.
Healthcare professionals using the device during angioplasty procedures are most at risk. Patients undergoing the procedure could be exposed to infection if the device is used with compromised sterility.
The device has catalog number IN2230 and was sold with specific lot numbers listed in the recall notice. It is used for inflating balloon angioplasty catheters and measuring pressure during procedures.
Look for the lot numbers H2287420 through H2599814 on the device packaging or label.
The recall states the device has holes in the Tyvek barrier due to manufacturing defects, so it should not be used until the recall is addressed.
The recall does not specify a remedy, so contact Merit Medical directly for guidance on next steps.
Check the device's catalog number (IN2230) and lot numbers listed in the recall notice (H2287420 through H2599814).
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0058-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0058-2025 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.
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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.
