FDA Device recall Z-3154-2026
Haylard UNIV IMAGING BIOPSY TRUCUSTOM
- FDA Device
- Class I
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class I recall of Haylard UNIV IMAGING BIOPSY TRUCUSTOM by Avid Medical, citing potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3154-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-08-10 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Avid Medical |
| Distribution | IL, NC, VA, WY |
Product
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.
Identifiers
| code_info | Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Rec…Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Avid Medical
- Halyard IV START KIT NON-STERILE
FDA Device · Class I · 2026-09-30 · Avid Medical - Halyard IV START KIT NON-STERILE
FDA Device · Class II · 2026-09-30 · Avid Medical - Halyard IV START KIT NON-STERILE
FDA Device · Class II · 2026-09-30 · Avid Medical - Haylard CONTINUOUS NERVE BLOCK TRAY
FDA Device · Class I · 2026-09-23 · Avid Medical - Haylard 18G SINGLE SHOT EPI TRAY
FDA Device · Class I · 2026-09-23 · Avid Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3154-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.