CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Halyard Davinci Trucustom Bundle containing Tray Foley W/Statlock recalled

AVID Medical is recalling Halyard Davinci Trucustom Bundle containing Tray Foley W/Statlock, distributed nationwide in the US. The recall was initiated on 9 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Lot Number: 1634391 UDI: 10809160439708

Quantity recalled45 kits

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-3005-2026
FDA event ID: 99527
Recalling firm: AVID Medical, Toano, VA
Classification: Class II
Status: Ongoing
Recall initiated: 9 Jul 2026
FDA classified: 21 Aug 2026
Reported: 2 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

9 Jul 2026	Recall initiated by company
21 Aug 2026	Classified by FDA	+43 days
2 Sep 2026	Published in enforcement report	+12 days

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

Reason for recall

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27

Where it was distributed

US Nationwide distribution in the states of MS, TX.

Nationwide Mississippi Texas

Questions about this recall

Is Halyard Davinci Trucustom Bundle containing Tray Foley W/Statlock recalled?

Yes. AVID Medical recalled Halyard Davinci Trucustom Bundle containing Tray Foley W/Statlock on 9 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-3005-2026.

Why was it recalled?

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Which lots are affected?

Lot Code: Lot Number: 1634391 UDI: 10809160439708

Where was it sold?

US Nationwide distribution in the states of MS, TX.

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.

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