Recall Z-0533-2026— Merit Medical Systems, Inc.

Name: FDA recall Z-0533-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-04

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2025-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: PhD Hemostasis Valve, REF: 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.. Reason: 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..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-04
Firm location: South Jordan, UT, United States

Product description

PhD Hemostasis Valve, REF: 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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.