Merit Medical Systems, Inc.: Device Recall

Recall #Z-0533-2026 · 08/04/2025

Class II: Risk

Recall Details

Recall Number
Z-0533-2026
Classification
Class II
Product Type
Device
Recalling Firm
Merit Medical Systems, Inc.
Status
Ongoing
Date Initiated
08/04/2025
Location
South Jordan, UT, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
217,141

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.

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.

Distribution Pattern

US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS, NJ, MI, VA, KY, AL, MT, NE, MA, MO, TN, CT, MD, WA, DC, ME, OR, NH, IN, GA, UT, OK, HI, RI, ID, NM, MS, WV, SD, DE, NV, ND. OUS: United Arab Emirates, Australia, Italy, Spain, Sweden, Norway, Germany, France, Belgium, Netherlands, Thailand, New Zealand, Mexico, Puerto Rico, Canada, Korea, Republic of, South Africa, Qatar, Iceland, United Kingdom, Viet Nam, Slovakia, Guam, Oman, Portugal, Madagascar, Saudi Arabia, Finland, Cyprus, Switzerland, Taiwan, China, Japan

Other Recalls by Merit Medical Systems, Inc.

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.