CLASS I ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report

Halyard IV Start Kit Non-sterile recalled by Avid Medical

Avid Medical is recalling Halyard IV Start Kit Non-sterile, distributed nationwide in the US. The recall was initiated on 22 Jul 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesKit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Number: 1658437. Expiration Date: 1/31/2027

Quantity recalled288 kits (6 cases)

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-3194-2026
FDA event ID: 99761
Recalling firm: Avid Medical, Toano, VA
Classification: Class I
Status: Ongoing
Recall initiated: 22 Jul 2026
FDA classified: 23 Sep 2026
Reported: 30 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Jul 2026	Recall initiated by company
23 Sep 2026	Classified by FDA	+63 days
30 Sep 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

Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.

Product as listed by the FDA

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.

Which lots are affected?

Kit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Number: 1658437. Expiration Date: 1/31/2027

Where was it sold?

US Nationwide distribution.

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 6 Oct 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 Avid Medical

All 192

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-sterile recalled by Avid Medical	Avid Medical	Packaging Defects	Nationwide
30 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-sterile recalled by Avid Medical	Avid Medical	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS I	Haylard Continuous Nerve Block Tray kits recalled by Avid Medical	Avid Medical	Sterility	4 states
23 Sep 2026Device	CLASS I	Halyard IV Start Kit Non-sterile recalled by Avid Medical	Avid Medical	Other	Nationwide
23 Sep 2026Device	CLASS I	Haylard Basic Biopsy Tray kits recalled by Avid Medical	Avid Medical	Sterility	4 states

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