FDA
Food and Drug Administration · Recall Z-2705-2026 · Jun 1, 2026One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Argon Medical Devices, Inc
The hazard
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 497455/20886333214635:00886333214631/11658984 (7/19/2027)UPC 20886333214499UPC 00886333214495UPC 20886333214635UPC 00886333214631Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.