Merit Medical recalls PhD Hemostasis Valves with specific model numbers due to a manufacturing defect that may cause leakage, leading to procedure inconvenience or hemorrhage.
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Merit Medical is recalling certain PhD Hemostasis Valves because a manufacturing defect can cause the valve cap to stay depressed, potentially leading to leakage during medical procedures. This could result in procedure delays or bleeding.
The valve cap may remain depressed due to a manufacturing defect, causing potential leakage. This leakage could lead to procedure inconvenience or hemorrhage during medical procedures.
Medical professionals using the recalled PhD Hemostasis Valves for procedures are most at risk. Patients undergoing surgery with these valves may experience procedure delays or bleeding.
Check the product model numbers listed in the recall notice: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
Identify the model number on the valve to see if it matches the recalled list.
The valve cap may remain depressed due to a manufacturing defect, leading to potential leakage.
The recall states it may result in procedure inconvenience or hemorrhage, but does not mention serious injury risk.
Check the model number against the list: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0533-2026 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0533-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.