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: 00884450816509

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-2003-2026
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: Sterility
Device type: Other Medical Devices

Timeline

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

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

Is Philips Bridge Prep Kit recalled?

Yes. Merit Medical Systems recalled Philips Bridge Prep Kit on 2 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2003-2026.

Why was it recalled?

catheter may experience resistance when being advanced over the guidewire

Which lots are affected?

All Lot Numbers/UDI: 00884450816509

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

More recalls from Merit Medical Systems

All 144

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Splashwire Hydrophilic Guide Wire recalled by Merit Medical Systems	Merit Medical Systems	Packaging Defects	Nationwide
6 May 2026Device	CLASS II	Philips Bridge Prep Kit recalled by Merit Medical Systems	Merit Medical Systems	Sterility	Nationwide
6 May 2026Device	CLASS II	Philips Bridge Prep Kit recalled by Merit Medical Systems	Merit Medical Systems	Sterility	Nationwide
1 Apr 2026Device	CLASS I	DuraMax Chronic Hemodialysis Catheter recalled by Merit Medical Systems	Merit Medical Systems	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS I	BioFlo DuraMax Catheter recalled by Merit Medical Systems	Merit Medical Systems	Device Malfunction	Nationwide

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