FDA
Food and Drug Administration · Recall Z-2704-2026 · Jun 1, 2026Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
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
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 008566A/20886333217643:00886333217649/11654475(12/31/2026)Model 11654478(7/19/2027)UPC 20886333217636UPC 00886333217632UPC 20886333217643UPC 00886333217649Would 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.