FDAHealthJune 1, 2026

Argon Medical Devices, Inc — Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A

⚠️ Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: June 1, 2026

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

What's affected?

Product: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Brand: Argon Medical Devices, Inc
Lot code: (Expiration):

Additional details

REF/UDI-DI Box:Unit/Lot(Expiration): 008416A/20886333217636:00886333217632/11656898(7/19/2027); 008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(7/19/2027)

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 950.

View original FDA notice →

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