Merit Medical 10Fore Hemostasis Valve Recall: Deformed Silicone Ring Risk
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/51737-merit-medical-10fore-hemostasis-valve-recall-deformed-silicone-ring-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/51737-merit-medical-10fore-hemostasis-valve-recall-deformed-silicone-ring-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2553-2025
Cite this page
“Merit Medical 10Fore Hemostasis Valve Recall: Deformed Silicone Ring Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51737-merit-medical-10fore-hemostasis-valve-recall-deformed-silicone-ring-risk. Based on FDA recall #Z-2553-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2553-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Medical professionals using the 10Fore Hemostasis Valve during procedures are most at risk. Patients receiving the valve during medical procedures may also be affected.
How to tell if you have this one
Check for catalog numbers: MAPTEN4 / 00884450821305, MAPTEN42 / 00884450832509, or MAPTEN452 / 00884450821329. Affected units have specific lot numbers listed in the recall notice.
- Brand
Merit Medical- Category
Medical device
What to do — step by step
Check Product Details
Review the catalog number and lot number on your 10Fore Hemostasis Valve to determine if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
FDA distribution: “Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY, SD, and WI. The countries of Canada and Korea” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Louisiana, Montana, New York, South Dakota, Wisconsin.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2553-2025 (July 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2553-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.