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fda_recall · device_recall · critical

Argon Medical Devices, Inc — Class I recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 0…

Event date
2026-07-22 00:00:00Z
Observed
2026-07-28 04:20:57Z
Source ID
Z-2704-2026
Payload hash
c5dab6b1dac73a172156ca24

Summary

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. Status: Ongoing.

Frequently asked questions

Has Argon Medical Devices, Inc had other FDA enforcement actions?
Yes. Argus HQ has recorded 6 total FDA actions tied to Argon Medical Devices, Inc: 0 warning letters, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2026-07-22; Argus observed and indexed it on 2026-07-28.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Argon Medical Devices, Inc — Class I recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 0…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-argon-medical-devices-inc-z-2704-2026
MLA
"Argon Medical Devices, Inc — Class I recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 0…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-argon-medical-devices-inc-z-2704-2026.
Chicago
Argus HQ Research. "Argon Medical Devices, Inc — Class I recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 0…." Digital Empire Holdings LLC. Accessed July 28, 2026. https://argushq.ai/events/fda-recall-argon-medical-devices-inc-z-2704-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_argon_medical_devices_inc_z_2704_2026_2026,
  title = {Argon Medical Devices, Inc — Class I recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 0…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-argon-medical-devices-inc-z-2704-2026},
  note = {Accessed: July 28, 2026}
}

Informational only. Not legal, financial, or medical advice.