Class I

Medical Device Recall: One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular

Argon Medical Devices, Inc · June 1, 2026

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.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

200

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2705-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Argon Medical Devices, Inc Medical Device Recall: One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular | SafeCheck