The Recall Desk
HighFDA (Devices)·Z-2517-2026·Announced 2026-06-24

Splashwire hydrophilic guide wire pouches have unsealed portions

Merit Medical Splashwire Hydrophilic Guide Wires are being recalled because of unsealed portions of pouches. 5,004 units are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where the pouch seal that maintains the sterile barrier is incomplete, a risk of harm with no injuries reported in the source.

Plain-English summary

The Splashwire Hydrophilic Guide Wire from Merit Medical Systems, Inc. is being recalled across REF MSWSTDA35150, MSWSTDA35180, MSWSTDA35260EX and MSWSTDA3580, among the catalog numbers listed in the recall notice. The action covers 5,004 units.

The stated reason is unsealed portions of pouches. The FDA classified the action as Class II.

Affected product spans the UDI-DI codes and lot numbers in the recall notice, including lots K3410951, K3420005, K3420006 and K3420007. Distribution was worldwide, including nationwide in the United States across a large number of states.

Facilities should identify affected stock using the REF numbers, UDI-DI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Merit Medical.

The recalled product

Product
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: 008844
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Guide wire
Hazard
Affected units
5,004

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

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