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FDAFDA · Food and drugs·Recall number Z-3154-2026

Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;

Published September 23, 2026 · Recall initiated: August 10, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
AVID Medical, Inc.
Distributor
Domestic: IL, NC, VA, WY;
Lot
Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;
Risk classification
Class I
Area (FDA)
device
Country
United States

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