# FDA recall Z-2704-2026

> **Argon Medical Devices, Inc** · Class I · device recall initiated 2026-06-01.

## Product

Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A

## Reason for recall

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

## Distribution

Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

## Key facts

- **Recall number:** Z-2704-2026
- **Recalling firm:** Argon Medical Devices, Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-01
- **Report date:** 2026-07-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2704-2026

## Citation

> MORVS. FDA recall Z-2704-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-2704-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*