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Ongoing FDAEvent 99672 (1 month ago)

AVID Medical Halyard IV Start Kits

Halyard IV Start Kit contains applicators 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 is recalling Halyard IV Start Kit NON-Sterile REF: KRIV26-02 because the convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators contaminated with Aspergillus penicillioides. The recall began on July 14, 2026, and was added to the FDA's Enforcement Report on September 14, 2026.

The product was distributed in the state of Nebraska. A total of 288 units are affected.

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 UDI-DI and lot code listed under your product.

  1. Halyard IV Start Kit NON-Sterile REF: KRIV26-02

    UDI-DI
    • 10809160460481
    Lot
    • 1658437

Details

Company began the recall
Sold in

US Nationwide distribution in the state of Nebraska.

Event ID
99672
Recall No.
Z-3108-2026
Company
AVID Medical, Inc.Toano, Virginia
Quantity recalled
288 units
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