Medical Device Recall: Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA
Merit Medical Systems, Inc. · May 8, 2026
Reason for Recall
Due to unsealed portions of pouches.
Product Description
Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 REF: MSWSTDA3580 UDI-DI codes: 00884450529645 00884450529690 00884450529744 REF: MSWSTDS35150 UDI-DI codes: 00884450529690 00884450529744 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 REF: MSWSTFA3580 UDI-DI code: 00884450529515 REF: MSWSTFS35150 UDI-DI code: 00884450529553 The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.
Distribution
Worldwide - U.S. Nationwide distribution in the states and territory AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico. The countries of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Ireland, Italy, Kazakhstan, Kenya, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland.
States Affected
NATIONWIDE
Quantity Affected
5,004
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2517-2026
Status: ongoing
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