Reported Jun 24, 2026 · Ongoing
Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
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Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes
4 of 4 products
| Model / number | Barcodes | Product as published |
|---|---|---|
00884450529645 | 0088445052966900884450529690 | REF: MSWSTDA35180 UDI-DI codes |
00884450529645 | 00884450529669 | REF: MSWSTDA35260EX UDI-DI code: 00884450529683 REF: MSWSTDA3580 UDI-DI codes |
00884450529645 | 0088445052969000884450529744 | 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. |
- Lot codes and dates
22 of 22 products
Products covered by this recall Model / number Barcodes Product as published MSWSTDA3515000884450529645UDI-DI code: 00884450529645 — 00884450529669Lot Numbers: K3410951 K3420005 K3420006 K3420007 K3420106 UDI-DI code: 00884450529669 — 00884450529690Lot Number: K3420005 UDI-DI code: 00884450529690 — Lot Number: K3420006 MSWSTDA3518000884450529645UDI-DI code: 00884450529645 — 00884450529669Lot Number: K3405121 UDI-DI code: 00884450529669 — Lot Numbers: K3405121 K3405126 K3405127 K3405128 K3405129 K3405130 K3410953 K3420010 MSWSTDA35260EX00884450529683UDI-DI code: 00884450529683 — Lot Numbers: K3405122 K3410937 K3410958 MSWSTDA358000884450529645UDI-DI code: 00884450529645 — 00884450529690Lot Number: K3405257 UDI-DI code: 00884450529690 — 00884450529744Lot Number: K3405257 UDI-DI code: 00884450529744 — Lot Number: K3405257 MSWSTDS3515000884450529690UDI-DI code: 00884450529690 — 00884450529744Lot Number: K3420082 UDI-DI code: 00884450529744 — Lot Numbers: K3420082 K3420101 MSWSTFA35260EX00884450529447UDI-DI code: 00884450529447 — Lot Number: K3405261 MSWSTFA358000884450529515UDI-DI code: 00884450529515 — Lot Number: K3420079 - Amount recalled
- 5,004
Where it was sold
Why it was recalled
Due to unsealed portions of pouches.
This product could cause temporary or reversible health problems — stop using it.
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