Merit Medical Systems, Inc. recalls Merit Medical , Custom Manifold Kit REF: K09-13203A

Recall date

December 4, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1127-2026

FDA classification

Class II

Brand / firm

Merit Medical Systems, Inc.

Sold / distributed

Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the…

Why it was recalled

Inflation device handle may detach from the syringe during procedure.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Merit Medical , Custom Manifold Kit REF: K09-13203A