CLASS I ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

Haylard Univ Imaging Biopsy Trucustom kits recalled by Avid Medical

Avid Medical is recalling Haylard Univ Imaging Biopsy Trucustom kits, distributed in Illinois, North Carolina, Virginia, Wyoming. The recall was initiated on 10 Aug 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;

Quantity recalled340 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3154-2026
FDA event ID: 99758
Recalling firm: Avid Medical, Toano, VA
Classification: Class I
Status: Ongoing
Recall initiated: 10 Aug 2026
FDA classified: 16 Sep 2026
Reported: 23 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Imaging Equipment

Timeline

10 Aug 2026	Recall initiated by company
16 Sep 2026	Classified by FDA	+37 days
23 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Domestic: IL, NC, VA, WY;

Illinois North Carolina Virginia Wyoming

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;

Where was it sold?

Domestic: IL, NC, VA, WY;

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 99758

This product is part of a recall event; the main page for the event is Haylard Single Shot Epi Tray kits recalled by Avid Medical.

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026	CLASS I	Haylard Single Shot Epi Tray kits recalled by Avid Medical	Avid Medical	Sterility	4 states
23 Sep 2026	CLASS I	Haylard Basic Biopsy Tray kits recalled by Avid Medical	Avid Medical	Sterility	4 states
23 Sep 2026	CLASS I	Haylard Continuous Nerve Block Tray kits recalled by Avid Medical	Avid Medical	Sterility	4 states

More recalls from Avid Medical

All 189

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	Haylard Continuous Nerve Block Tray kits recalled by Avid Medical	Avid Medical	Sterility	4 states
23 Sep 2026Device	CLASS I	Halyard IV Start Kit Non-sterile recalled by Avid Medical	Avid Medical	Other	Nationwide
23 Sep 2026Device	CLASS I	Haylard Basic Biopsy Tray kits recalled by Avid Medical	Avid Medical	Sterility	4 states
23 Sep 2026Device	CLASS I	Haylard Single Shot Epi Tray kits recalled by Avid Medical	Avid Medical	Sterility	4 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide

Other Imaging Equipment recalls

All 2,339

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Core Services Hub V8, a set of backend services including recalled	GE Healthcare	Other	Nationwide
23 Sep 2026Device	CLASS II	Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide