Class I

Medical Device Recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A

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

950

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2704-2026

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.