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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Philips Bridge Prep Kit Recalled for Catheter Advancement Issues

Agency Publication Date: April 29, 2026
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Summary

Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (model numbers K12-09098B and K12-09098C) because the catheter may experience resistance when being moved over the guidewire during use. This issue can complicate medical procedures and potentially cause delays or internal injuries. These kits are sterile medical devices used in clinical settings and were distributed in Colorado.

Risk

Resistance during catheter advancement can cause the device to get stuck or fail to reach its intended destination, which may result in vessel damage, internal bleeding, or prolonged procedure time while the device is removed and replaced.

What You Should Do

  1. Stop using the recalled Philips Bridge Prep Kit immediately.
  2. Check your clinical inventory for Philips Bridge Prep Kit REF: K12-09098B with UDI 00884450771310, or REF: K12-09098C with UDIs 00884450816509 or 00884450024140.
  3. Contact Merit Medical Systems, Inc. or your clinical distributor to arrange for the return, replacement, or correction of the affected kits.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Philips Bridge Prep Kit
Model / REF:
K12-09098B
UDI:
00884450771310

Sterile EO, Rx ONLY

Product: Philips Bridge Prep Kit
Model / REF:
K12-09098C
UDI:
00884450816509
00884450024140

Sterile EO, Rx ONLY

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98637
Status: Active
Manufacturer: Merit Medical Systems, Inc.
Sold By: Medical distributors
Manufactured In: United States
Distributed To: Colorado

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.