Merit Medical Splashwire Hydrophilic Guide Wire Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Merit Medical Systems, Inc. is recalling 5,004 units of Splashwire Hydrophilic Guide Wire due to unsealed portions of pouches.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 2, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Merit Medical Systems, Inc. initiated a voluntary recall of the Splashwire Hydrophilic Guide Wire due to unsealed portions of pouches. The recall is classified as Class II by the FDA.
Which Products Are Affected
The affected products are Splashwire Hydrophilic Guide Wire with the following references and UDI-DI codes:
- 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)
Specific lot numbers are detailed in the recall notice. A total of 5,004 units are affected. Distribution includes U.S. nationwide in 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, as well as Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Ireland, Italy, Kazakhstan, Kenya, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland.
What You Should Do
The recall notice does not specify consumer actions. The product is intended for use in the peripheral vascular system to facilitate device placement during diagnostic and interventional procedures.
Why This Matters
This Class II recall involves 5,004 units distributed worldwide, addressing a potential packaging integrity issue.
Source
FDA recall number Z-2517-2026, Merit Medical Systems, Inc., South Jordan, UT.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,726 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.