Merit Medical Systems, Inc. recalls Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
- Recall date
- December 4, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1128-2026
- 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 Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
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