Lower risk Medical device recall · FDA · Published May 8, 2026

Merit Medical Splashwire Hydrophilic Guide Wire Recall: Unsealed Pouches Risk

Merit Medical recalls Splashwire Hydrophilic Guide Wire with unsealed pouches that may cause contamination during medical procedures. Affected units have specific UDI-DI codes and lot numbers. Consumers should contact Merit for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2517-2026Medical device Merit Medical ›

Lower-risk recall

Due to unsealed portions of pouches.

Take action

Contact the company

Recalling firmMerit Medical Systems, Inc.1600 W Merit Pkwy · South Jordan, UT 84095-2416

✎ GovInfoNow plain-language explainer

Merit Medical is recalling certain Splashwire Hydrophilic Guide Wires due to unsealed pouches that could lead to contamination during medical procedures. This recall affects specific units with listed UDI-DI codes and lot numbers. Read more at govinfonow.com/recall/49192-merit-medical-splashwire-hydrophilic-guide-wire-recall-unsealed-pouches-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/49192-merit-medical-splashwire-hydrophilic-guide-wire-recall-unsealed-pouches-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2517-2026

Cite this page

“Merit Medical Splashwire Hydrophilic Guide Wire Recall: Unsealed Pouches Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49192-merit-medical-splashwire-hydrophilic-guide-wire-recall-unsealed-pouches-risk. Based on FDA recall #Z-2517-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2517-2026%22&limit=1).

The FDA announced on May 8, 2026, that Merit Medical Systems is recalling Splashwire Hydrophilic Guide Wires due to unsealed pouch portions. The agency issued recall number Z-2517-2026 for the Class II device.

How to tell if you have it

Brand: Merit Medical
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: 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 hazard

The recall is due to unsealed portions of the product's pouches. The Splashwire Hydrophilic Guide Wire is intended for use in the peripheral vascular system to facilitate device placement during diagnostic and interventional procedures.

Context

GovInfoNow's records show Merit Medical Systems, Inc has 37 other recalls on record since 2006-02-24. Other recent recalls of similar products include Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam (2026-08-10), Philips Bridge Prep Kit Recall (2026-04-02), and Merit Medical ProGuide Dialysis Catheters Recall (2026-02-13). Other recent recalls of similar products include Stryker Daig Livewire Steerable Catheter Recall: Incomplete Sterile Seals (2026-04-10), Stryker Daig Livewire Steerable Catheter Recall: Incomplete Sterile Seals Risk (2026-04-10), and Medtronic Bio-Medicus Adult Cannula Kit Recall (2026-05-25).

How to tell if you have this one

Check for UDI-DI codes: 00884450529645, 00884450529669, 00884450529690, 00884450529683, 00884450529744, 00884450529515, 00884450529553. Also look for lot numbers like K3410951, K3420005, K3420006, K3420007, K3420106.

Brand
Merit Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Merit Medical
Reach out to Merit Medical Systems, Inc. for specific guidance on affected units and next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 33 states.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 47 days after the firm started it.

May 8, 2026Firm started the recall
Jun 18, 2026FDA classified it Class II
Jun 24, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Merit Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/49192-merit-medical-splashwire-hydrophilic-guide-wire-recall-unsealed-pouches-risk">Merit Medical Splashwire Hydrophilic Guide Wire Recall: Unsealed Pouches Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2517-2026 (May 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2517-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.