Recall Z-2706-2026— Argon Medical Devices, Inc

Name: FDA recall Z-2706-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-01

Class I · Ongoing

Class I FDA medical device recall by Argon Medical Devices, Inc, initiated 2026-06-01. It names one FDA 510(k) clearance: K980196. Product: General Biospy Tray, REF: GUTS1000. Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility..

Recalling firm: Argon Medical Devices, Inc
Classification: Class I
Status: Ongoing
Initiated: 2026-06-01
Firm location: Athens, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K980196 — MD TECH BIOPSY SET FOR BONE AND BONE MARROWMedical Device Technologies, Inc.·cleared 1998-02-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

General Biospy Tray, REF: GUTS1000

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.