FDAFDA recall Z-2705-2026 · Jul 22, 2026
Argon Medical Devices, Inc: One-Piece Introducer Tray recall
Recall found
Product
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- REF/UDI-DI Box:Unit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027);
- Quantity
- 200
- Distribution
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- Recalling firm
- Argon Medical Devices, Inc, Athens, TX
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-01
Source: openFDA enforcement record Z-2705-2026 · search recall number Z-2705-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.