Merit Medical recalls 10Fore Hemostasis Valves with deformed silicone rings that may cause foreign bodies in fluid pathways. Affected units have specific catalog numbers and lot numbers.
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Merit Medical is recalling 10Fore Hemostasis Valves that have a deformed silicone ring which could cause a foreign body in the fluid pathway. This could lead to complications during medical procedures.
The silicone quad ring in the valve can become deformed or damaged during manufacturing. This deformation may cause a foreign body to enter the fluid pathway, potentially leading to complications during medical procedures.
Medical professionals using the 10Fore Hemostasis Valve during procedures are most at risk. Patients receiving the valve during medical procedures may also be affected.
Check for catalog numbers: MAPTEN4 / 00884450821305, MAPTEN42 / 00884450832509, or MAPTEN452 / 00884450821329. Affected units have specific lot numbers listed in the recall notice.
Review the catalog number and lot number on your 10Fore Hemostasis Valve to determine if it is affected.
The silicone quad ring can become deformed or damaged, which may cause a foreign body to enter the fluid pathway during medical procedures.
Check for catalog numbers: MAPTEN4 / 00884450821305, MAPTEN42 / 00884450832509, or MAPTEN452 / 00884450821329. Affected units have specific lot numbers listed in the recall notice.
The recall does not specify a remedy, so contact Merit Medical directly for further instructions.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2553-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-2553-2025 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.
