Merit Medical recalls 30 ATM Monarch syringes with Tyvek barrier holes that could allow infection during procedures. Affected units have specific lot numbers. Consumers should contact Merit for details.
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Merit Medical is recalling their Monarch :30 atm/bar syringes because manufacturing flaws created holes in the sterile Tyvek barrier. This could let bacteria enter during medical procedures, risking infection for patients.
The syringe's Tyvek sterile barrier has manufacturing holes that could allow bacteria to enter the body during procedures. This poses an infection risk if the syringe is used without proper sterility.
Healthcare professionals using the Monarch syringes for angioplasty procedures are most at risk. Patients receiving procedures with these syringes could face infection.
Check for the catalog number IN2330/B on the syringe or packaging. The affected units have specific lot numbers listed in the recall notice.
Look for the catalog number IN2330/B and lot numbers H2369557 through H2579556 on the syringe or packaging.
The recall is due to manufacturing holes in the Tyvek sterile barrier that could allow bacteria to enter during procedures.
Check the catalog number and lot numbers on the syringe or packaging. Contact Merit Medical Systems for further instructions.
Yes, the holes in the sterile barrier could allow bacteria to enter the body during procedures, increasing infection risk.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0059-2025 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-0059-2025 from Merit Medical Systems. 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.
