AVID Medical Halyard IV Start Kits
The Halyard IV Start Kit lacks sterility assurance due to wrinkles in the paper lidding that may breach the seal area.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
AVID Medical, Inc., of Toano, Virginia, recalled 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 that lack sterility assurance due to wrinkles in the paper lidding which may breach the seal area. The recall began July 14, 2026, and was added to the FDA's Enforcement Report on September 4, 2026.
The recalled kits were distributed in the state of Nebraska. The FDA classified the recall on September 4, 2026, and in the FDA's weekly enforcement report on September 16, 2026.
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:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- 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.
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
- UDI-DI
- 10809160460481
- Lot
- 1658438
Details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Nebraska.
- Event ID
- 99525
- Recall No.
- Z-3109-2026
- Company
- AVID Medical, Inc.Toano, Virginia
- Hazard
- Sterility failure
- Quantity recalled
- 98 Kits
- Recall type
- Voluntary: Firm initiated
- Customers told by
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
