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Splashwire Hydrophilic Guide Wire
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MEDICAL DEVICE RECALLMODERATE

Splashwire Hydrophilic Guide Wire

Merit Medical is recalling various Splashwire Hydrophilic Guide Wire models due to unsealed pouches that may compromise device sterility.

What to do

Healthcare facilities should immediately inspect their inventory for the affected guide wires and discontinue use of any units with compromised or unsealed packaging.

Recalled
Listed
Updated
Recall No.
Z-2517-2026
Agency
FDA
Firm
Merit Medical Systems, Inc.
Recall ID
98818
Status
ONGOING

Why it was recalled

Merit Medical Systems is recalling various Splashwire Hydrophilic Guide Wire models due to unsealed portions of the product pouches, which may compromise the sterility of the device.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductUDI-DI
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 REF00884450529645, 00884450529669, 00884450529690, 00884450529645, 00884450529669, 00884450529683, 00884450529645, 00884450529690, 00884450529744, 00884450529690, 00884450529744, 00884450529447, 00884450529515, 00884450529553
REF: MSWSTDA3515000884450529645, 00884450529669, 00884450529690
REF: MSWSTDA3518000884450529645, 00884450529669
REF: MSWSTDA35260EX00884450529683
REF: MSWSTDA358000884450529645, 00884450529690, 00884450529744
REF: MSWSTDS3515000884450529690, 00884450529744
REF: MSWSTFA35260EX00884450529447
REF: MSWSTFA358000884450529515
REF: MSWSTFS3515000884450529553

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Packaging Defect recalls

Other recent recalls from Merit Medical Systems, Inc.

All recalls from Merit Medical Systems, Inc.

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Editorial summary by Recall Canary · summary updated 2026-06-19 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification