FDA recall, , Moderate risk
Merit Medical Systems Splashwire Hydrophilic Guide Wire
The Splashwire Hydrophilic Guide Wire has unsealed portions of pouches.
Summary by Recall Canary from the FDA notice
What happened
Merit Medical Systems, Inc., of South Jordan, Utah, recalled the Splashwire Hydrophilic Guide Wire because of unsealed portions of pouches. The FDA listed the recall on June 18, 2026, after the company began it on May 8, 2026. The product was distributed nationwide in the U.S. and internationally, including in many states and countries such as Austria, Belgium, and France.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
REF: MSWSTDA35150
- UDI-DI
- 00884450529645
- 00884450529669
- 00884450529690
REF: MSWSTDA35180
- UDI-DI
- 00884450529645
- 00884450529669
REF: MSWSTDA35260EX
- UDI-DI
- 00884450529683
REF: MSWSTDA3580
- UDI-DI
- 00884450529645
- 00884450529690
- 00884450529744
REF: MSWSTDS35150
- UDI-DI
- 00884450529690
- 00884450529744
REF: MSWSTFA35260EX
- UDI-DI
- 00884450529447
REF: MSWSTFA3580
- UDI-DI
- 00884450529515
REF: MSWSTFS35150
- UDI-DI
- 00884450529553
Recall details
- Company began the recall
- Sold in
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.
- Company
- Merit Medical Systems, Inc.South Jordan, Utah
- Hazard
- Packaging defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98818
- Recall number
- Z-2517-2026
All recalls from Merit Medical Systems, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
