Philips recalls Bridge Prep Kit REF K12-09098C (Sterile EO, Rx ONLY) due to catheter resistance during guidewire advancement. Affected units have specific lot numbers.
“Philips Bridge Prep Kit Recall: Catheter Resistance Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49563-philips-bridge-prep-kit-recall-catheter-resistance-risk. Based on FDA recall #Z-2003-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2003-2026%22&limit=1).
The FDA announced on April 2, 2026, that Merit Medical Systems, Inc. is voluntarily recalling Philips Bridge Prep Kit REF: K12-09098C Sterile EO devices because the catheter may experience resistance when being advanced over the guidewire.
How to tell if you have it
Brand: Philips
Product: Bridge Prep Kit
REF: K12-09098C
Lot Numbers/UDI: 00884450816509
The hazard
The recall involves a potential issue where the catheter may experience resistance when being advanced over the guidewire, according to the FDA.
Context
GovInfoNow's records show Merit Medical Systems, Inc. has had 37 other recalls on record since February 24, 2006. Other recent recalls of similar products include Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam (August 10, 2026), Splashwire Hydrophilic Guide Wire Recall (May 8, 2026), and BioFlo DuraMax Catheter Recall (February 13, 2026).
How to tell if you have this one
Check for the product name 'Bridge Prep Kit' with reference number K12-09098C. Affected units have specific lot numbers: 00884450816509.
Brand
Philips
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the state of CO.
Recall number
Product, codes & lots
Quantity
Z-2002-2026
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY; All Lot Numbers/UDI: 00884450771310
—
Z-2003-2026
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY; All Lot Numbers/UDI: 00884450816509
—
Z-2004-2026
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY; All Lot Numbers/UDI: 00884450024140
—
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name and reference number on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of CO.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2003-2026 (April 2, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2003-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.