CLASS I ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report

General Biospy Tray recalled by Argon Medical Devices

Argon Medical Devices is recalling General Biospy Tray, distributed nationwide in the US. The recall was initiated on 1 Jun 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesREF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028)

Quantity recalled1800

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-2706-2026
FDA event ID: 99069
Recalling firm: Argon Medical Devices, Athens, TX
Classification: Class I
Status: Ongoing
Recall initiated: 1 Jun 2026
FDA classified: 10 Jul 2026
Reported: 22 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

1 Jun 2026	Recall initiated by company
10 Jul 2026	Classified by FDA	+39 days
22 Jul 2026	Published in enforcement report	+12 days

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

Reason for recall

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

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

General Biospy Tray, REF: GUTS1000

Where it was distributed

Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

Nationwide Puerto Rico

Questions about this recall

Is General Biospy Tray recalled?

Yes. Argon Medical Devices recalled General Biospy Tray on 1 Jun 2026. The recall is Class I and its status is Ongoing. Recall number Z-2706-2026.

Why was it recalled?

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Which lots are affected?

REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028)

Where was it sold?

Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

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

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