Skip to main content

Ongoing FDAEvent 99758 (29 days ago)

Halyard Medical Trays

Haylard 18G Single Shot EPI Tray may have quality and sterility issues.

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 recalled four Haylard products because kits containing Sodium Chloride ampules subject to recall by Spectra Medical may have quality and sterility issues. The products include the Haylard Univ Imaging Biopsy Trucustom, Haylard Basic Biopsy Tray, Haylard Single Shot Epi Tray, and Haylard Continuous Nerve Block Tray.

The recall began August 10, 2026, and was added to the FDA's Enforcement Report on September 16, 2026, with distribution in Illinois, North Carolina, Virginia, and Wyoming.

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?

4 products

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

  1. Haylard Univ Imaging Biopsy Trucustom; Model/Item Number (Kit): VARV042-03;

    UDI-DI
    • 10809160490822
    Lot
    • 1668365
    • 1668366
    • 1688166
    • 1692637
    • 1696930
    • AB5002
    • AB4003
  2. Haylard Basic Biopsy Tray; Model/Item Number (Kit): PM415;

    UDI-DI
    • 10809160322154
    Lot
    • 1652485
    • 1656642
    • 1667835
    • 1676219
    • 1682251
    • 1691940
    • AB5002
    • AB4003
  3. Haylard 18G Single Shot EPI Tray; Model/Item Number (Kit): DPGE002-02;

    UDI-DI
    • 10809160410325
    Lot
    • 1641713
    • 1641714
    • 1659697
    • 1668209
    • AB4003
  4. Haylard Continuous Nerve Block Tray; Model/Item Number (Kit): BMCN001-05;

    UDI-DI
    • 10809160455128
    Lot
    • 1703122
    • 1707656
    • 1708053
    • AB5002

Details

Company began the recall
Event ID
99758
Recall numbers
Z-3151-2026 to Z-3154-2026
Company
AVID Medical, Inc.Toano, Virginia
Recall type
Voluntary: Firm initiated
Customers told by
Letter
  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