Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes:… — Class II medical device recall Z-2517-2026
Ongoing recall by Merit Medical Systems, Inc., reported 2026-06-24, distributed nationwide. Due to unsealed portions of pouches.
| Recall number | Z-2517-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2026-05-08 |
| Classified | 2026-06-18 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, DK, ES, FI, FR, GR, GT, IE, IT, KE, NL, NO, PT, SE |
| Quantity | 5,004 |
| UPC / GTIN / UDI-DI | 00884450529447, 00884450529515, 00884450529553, 00884450529645, 00884450529669, 00884450529683, 00884450529690, 00884450529744 |
| Lot numbers | K3399729, K3405121, K3405122, K3405126, K3405127, K3405128, K3405129, K3405130, K3405257, K3405261, K3410937, K3410951, K3410953, K3410958, K3420005, K3420006, K3420007, K3420010, K3420079, K3420082, K3420101, K3420106 |
| Model numbers | MSWSTDA35150, MSWSTDA35180, MSWSTDA35260EX, MSWSTDA3580, MSWSTDS35150, MSWSTFA35260EX, MSWSTFA3580, MSWSTFS35150 |
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 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.
Reason for recall
Due to unsealed portions of pouches.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2517-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.