CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report

Splashwire Hydrophilic Guide Wire recalled by Merit Medical Systems

Merit Medical Systems is recalling Splashwire Hydrophilic Guide Wire, distributed nationwide in the US. The recall was initiated on 8 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF: MSWSTDA35150 UDI-DI code: 00884450529645 Lot Numbers: K3410951 K3420005 K3420006 K3420007 K3420106 UDI-DI code: 00884450529669 Lot Number: K3420005 UDI-DI code: 00884450529690 Lot Number: K3420006 REF: MSWSTDA35180 UDI-DI code: 00884450529645 Lot Number: K3405121 UDI-DI code: 00884450529669 Lot Numbers: K3405121 K3405126 K3405127 K3405128 K3405129 K3405130 K3410953 K3420010 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 Lot Numbers: K3405122 K3410937 K3410958 REF: MSWSTDA3580 UDI-DI code: 00884450529645 Lot Number: K3405257 UDI-DI code: 00884450529690 Lot Number: K3405257 UDI-DI code: 00884450529744 Lot Number: K3405257 REF: MSWSTDS35150 UDI-DI code: 00884450529690 Lot Number: K3420082 UDI-DI code: 00884450529744 Lot Numbers: K3420082 K3420101 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 Lot Number: K3405261 REF: MSWSTFA3580 UDI-DI code: 00884450529515 Lot Number: K3420079 REF: MSWSTFS35150 UDI-DI code: 00884450529553 Lot Number: K3399729

Quantity recalled5,004

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2517-2026
FDA event ID: 98818
Recalling firm: Merit Medical Systems, South Jordan, UT
Classification: Class II
Status: Ongoing
Recall initiated: 8 May 2026
FDA classified: 18 Jun 2026
Reported: 24 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

8 May 2026	Recall initiated by company
18 Jun 2026	Classified by FDA	+41 days
24 Jun 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to unsealed portions of pouches.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arizona California Florida Georgia Iowa Idaho Illinois Indiana Kansas Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi North Carolina New Hampshire New Jersey

Questions about this recall

Why was it recalled?

Due to unsealed portions of pouches.

Which lots are affected?

REF: MSWSTDA35150 UDI-DI code: 00884450529645 Lot Numbers: K3410951 K3420005 K3420006 K3420007 K3420106 UDI-DI code: 00884450529669 Lot Number: K3420005 UDI-DI code: 00884450529690 Lot Number: K3420006 REF: MSWSTDA35180 UDI-DI code: 00884450529645 Lot Number: K3405121 UDI-DI code: 00884450529669 Lot Numbers: K3405121 K3405126 K3405127 K3405128 K3405129 K3405130 K3410953 K3420010 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 Lot Numbers: K3405122 K3410937 K3410958 REF: MSWSTDA3580 UDI-DI code: 00884450529645 Lot Number: K3405257 UDI-DI code: 00884450529690 Lot Number: K3405257 UDI-DI code: 00884450529744 Lot Number: K3405257 REF: MSWSTDS35150 UDI-DI code: 00884450529690 Lot Number: K3420082 UDI-DI code: 00884450529744 Lot Numbers: K3420082 K3420101 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 Lot Number: K3405261 REF: MSWSTFA3580 UDI-DI code: 00884450529515 Lot Number: K3420079 REF: MSWSTFS35150 UDI-DI code: 00884450529553 Lot Number: K3399729

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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