FDAHealthJune 1, 2026

Argon Medical Devices, Inc — One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular

⚠️ 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: One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Brand: Argon Medical Devices, Inc
Lot code: (Expiration):

Additional details

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

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 200.

View original FDA notice →

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