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Ongoing FDAEvent 99761 (22 days ago)

AVID Medical Halyard IV Start Kits

Halyard IV Start Kit NON-Sterile may be contaminated with Aspergillus penicillioides.

High risk

There is a reasonable chance that using it could cause serious health problems or death.

FDA Class I recall · How risk is rated

What to do

What happened

AVID Medical, Inc., of Toano, Virginia, began a recall of the Halyard IV Start Kit NON-Sterile on July 22, 2026, because the convenience kits contain BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides. The recall was added to the FDA's Enforcement Report and classified on September 23, 2026, and in the FDA's weekly enforcement report on September 30, 2026.

The recalled kits have model number KRIV26-02 and were distributed nationwide in the US. Each case contains 48 kits, and the recall involves 288 kits, or 6 cases.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is your kit affected?

Match the model number, UDI-DI and lot code listed under your product.

  1. 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit

    Model
    • KRIV26-02
    UDI-DI
    • 10809160460481
    Lot
    • 1658437

Details

Company began the recall
Sold in

US Nationwide distribution.

Event ID
99761
Recall No.
Z-3194-2026
Company
AVID Medical, Inc.Toano, Virginia
Quantity recalled
288 kits (6 cases)
Recall type
Voluntary: Firm initiated
Customers told by
E-Mail
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

All recalls from AVID Medical, Inc.

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration