Splashwire hydrophilic guide wire pouches have unsealed portions
Merit Medical Splashwire Hydrophilic Guide Wires are being recalled because of unsealed portions of pouches. 5,004 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where the pouch seal that maintains the sterile barrier is incomplete, a risk of harm with no injuries reported in the source.
Plain-English summary
The Splashwire Hydrophilic Guide Wire from Merit Medical Systems, Inc. is being recalled across REF MSWSTDA35150, MSWSTDA35180, MSWSTDA35260EX and MSWSTDA3580, among the catalog numbers listed in the recall notice. The action covers 5,004 units.
The stated reason is unsealed portions of pouches. The FDA classified the action as Class II.
Affected product spans the UDI-DI codes and lot numbers in the recall notice, including lots K3410951, K3420005, K3420006 and K3420007. Distribution was worldwide, including nationwide in the United States across a large number of states.
Facilities should identify affected stock using the REF numbers, UDI-DI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Merit Medical.
The recalled product
- 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…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Guide wire
- Affected units
- 5,004
Distribution
Related recalls
Same manufacturer · Merit Medical Systems, Inc.
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- SevereDuraMax hemodialysis catheter sheath introducer may not split as intended
FDA (Devices) · 2026-04-01
Same hazard · sterile barrier
See all →- HighCovidien EndoStitch loading unit pouches may have sterility-breaking holes
FDA (Devices) · 2026-06-10
- HighReprocessed electrophysiology catheters recalled over incomplete sterile seals
FDA (Devices) · 2026-05-20
- HighCatheter cutdown trays recalled over damage to the outer tray
FDA (Devices) · 2026-02-25
- HighMediHoney wound gel recalled over potential packaging failures
FDA (Devices) · 2026-02-25
- HighVascular access kits and trays recalled over open swabstick seals
FDA (Devices) · 2026-02-18
Similar recalls
- ModerateMerit Medical Recalls Mixed Hydrophilic Guide Wire Lots
FDA (Devices) · 2014-04-30
- ModerateMerit Medical Recalls Hydrophilic Guide Wires Due to Labeling Discrepancy
FDA (Devices) · 2014-04-30
- HighVascular catheter wire guide recalled for sterility testing failure
FDA (Devices) · 2022-09-21
- HighVascular Wire Guide Recalled Due to Sterility Concerns From Packaging Failure
FDA (Devices) · 2022-09-21
- HighVascular wire guides recalled due to potential sterility compromise
FDA (Devices) · 2022-09-21
- HighRoadrunner UniGlide Vascular Wire Guide Recalled for Sterility Compromise
FDA (Devices) · 2022-09-21