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Philips Bridge Prep Kit
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MEDICAL DEVICE RECALLMODERATE

Philips Bridge Prep Kit

Merit Medical recalls Philips Bridge Prep Kit (REF K12-09098B) over catheter resistance on guidewire.

What to do

Do not use the affected kit. Contact Merit Medical Systems, Inc. for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-2003-2026
Agency
FDA
Firm
Merit Medical Systems, Inc.
Recall ID
98637
Status
ONGOING

Why it was recalled

Merit Medical is recalling the Philips Bridge Prep Kit (REF K12-09098B) because the catheter may experience resistance when advanced over the guidewire, potentially causing procedural complications. The affected kit is sterile, ethylene oxide (EO) sterilized, and for prescription use only.

Is mine affected?

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

Philips Bridge Prep Kit REF

ProductRecall #UDI-DI
K12-09098C Sterile EO, Rx ONLYZ-2003-202600884450816509
K12-09098B Sterile EO, Rx ONLYZ-2002-202600884450771310
K12-09098C Sterile EO, Rx ONLYZ-2004-202600884450024140

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 recent recalls from Merit Medical Systems, Inc.

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification