FDAFDA · Food and drugs·Recall number Z-2704-2026
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Published July 22, 2026 · Recall initiated: June 1, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Argon Medical Devices, Inc
- Distributor
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- Lot
- REF/UDI-DI Box:Unit/Lot(Expiration): 008416A/20886333217636:00886333217632/11656898(7/19/2027); 008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(7/19/2027)
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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