← FDA ENFORCEMENT
Z-2705-2026Class I

Argon Medical Devices, Inc

Recalling firm
Argon Medical Devices, Inc
Product type
Device
Status
Ongoing
Report date
2026-07-22
Distribution
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Firm state
TX
Product quantity
200
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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.

Product description

One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular

Code / lot info

REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IFrutas y Hortalizas del Sur S.A.2026-07-22Class IIGELLERT GLOBAL GROUP2026-07-22Class IICareFusion 213, LLC2026-07-22Class IIChiesi USA, Inc.
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.