Recall Z-2708-2026— Argon Medical Devices, Inc

Name: FDA recall Z-2708-2026
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: K780871. Product: Arterial Line Kit 20ga x 6, REF: 400115A. 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

K780871 — ARTERIAL LINE KITArgon Medical Corp.·cleared 1978-06-14

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

Arterial Line Kit 20ga x 6, REF: 400115A

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.