Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F recall (Argon Medical Devices, Inc)
Medical deviceClass IOngoing
Summary: Argon Medical Devices, Inc is recalling Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A. Reason: 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 is being recalled
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Why
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago. (states named: Puerto Rico)
How to tell if yours is affected
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)
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2704-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | June 1, 2026 |
| Reported | July 22, 2026 |
| Company | Argon Medical Devices, Inc |
| Company location | Athens, TX, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 950 |
More recalls from Argon Medical Devices, Inc · all medical device recalls · recalls from June 2026