Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall (AVID Medical, Inc.)
Medical deviceClass IOngoing
Summary: AVID Medical, Inc. is recalling Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;. Reason: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
What is being recalled
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
Why
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Domestic: IL, NC, VA, WY; (states named: Illinois, North Carolina, Virginia, Wyoming)
How to tell if yours is affected
Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3154-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | August 10, 2026 |
| Reported | September 23, 2026 |
| Company | AVID Medical, Inc. |
| Company location | Toano, VA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 340 kits |
More recalls from AVID Medical, Inc. · all medical device recalls · recalls from August 2026