Reported Jul 22, 2026 · Ongoing · Updated Sep 16, 2026
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Argon Medical Devices, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Argon Medical Devices, Inc · 1445 Flat Creek Rd · Athens, TX · 75751-5002
Is this the product you have?
- One-Piece Introducer Tray
- REF
497455497434 cardiovascular
- Lot codes and dates
- REF/UDI-DI BoxUnit/Lot(Expiration): 497434/20886333214499:00886333214495/11656891(7/19/2027); 497455/20886333214635:00886333214631/11658984 (7/19/2027)
- Amount recalled
- 200
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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