Argon Medical Devices, Inc recalls One-Piece Introducer Tray
- Recalling company
- Argon Medical Devices, Inc
- Product
- One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
- Reason
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Jun 1, 2026
- Reported
- Jul 22, 2026
- Distribution
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- Status
- Ongoing
- Quantity
- 200
- Lot / codes
- REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);
- Company location
- Athens, TX
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2705-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2705-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.