FDAFDA recall Z-3154-2026 · Sep 23, 2026
AVID Medical, Inc.: Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall
Recall found
Product
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
Reason for recall
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;
- Quantity
- 340 kits
- Distribution
- Domestic: IL, NC, VA, WY;
- Recalling firm
- AVID Medical, Inc., Toano, VA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-10
Source: openFDA enforcement record Z-3154-2026 · search recall number Z-3154-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.