CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report

Philips Bridge Prep Kit recalled by Merit Medical Systems

Merit Medical Systems is recalling Philips Bridge Prep Kit, distributed nationwide in the US. The recall was initiated on 2 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lot Numbers/UDI: 00884450024140

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2004-2026
FDA event ID
98637
Recalling firm
Merit Medical Systems, South Jordan, UT
Classification
Class II
Status
Ongoing
Recall initiated
2 Apr 2026
FDA classified
29 Apr 2026
Reported
6 May 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

2 Apr 2026Recall initiated by company
29 Apr 2026Classified by FDA+27 days
6 May 2026Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

catheter may experience resistance when being advanced over the guidewire

Product as listed by the FDA

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

Where it was distributed

US Nationwide distribution in the state of CO.

Nationwide Colorado

Questions about this recall

Why was it recalled?

catheter may experience resistance when being advanced over the guidewire

Which lots are affected?

All Lot Numbers/UDI: 00884450024140

Where was it sold?

US Nationwide distribution in the state of CO.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 98637

This product is part of a recall event; the main page for the event is Philips Bridge Prep Kit recalled by Merit Medical Systems.

ReportedClassRecallCompanyReasonWhere
CLASS IIPhilips Bridge Prep Kit recalled by Merit Medical SystemsMerit Medical SystemsOtherNationwide
CLASS IIPhilips Bridge Prep Kit recalled by Merit Medical SystemsMerit Medical SystemsOtherNationwide

More recalls from Merit Medical Systems

All 144
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IISplashwire Hydrophilic Guide Wire recalled by Merit Medical SystemsMerit Medical SystemsPackaging DefectsNationwide
DeviceCLASS IIPhilips Bridge Prep Kit recalled by Merit Medical SystemsMerit Medical SystemsOtherNationwide
DeviceCLASS IIPhilips Bridge Prep Kit recalled by Merit Medical SystemsMerit Medical SystemsOtherNationwide
DeviceCLASS IDuraMax Chronic Hemodialysis Catheter recalled by Merit Medical SystemsMerit Medical SystemsDevice MalfunctionNationwide
DeviceCLASS IBioFlo DuraMax Catheter recalled by Merit Medical SystemsMerit Medical SystemsDevice MalfunctionNationwide

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