# FDA recall Z-1618-2024

> **EBI, LLC** · Class II · device recall initiated 2024-03-22.

## Product

20" Lead Wires, Replacement  Part Number: 1067724-2

## Reason for recall

Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1618-2024
- **Recalling firm:** EBI, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-22
- **Report date:** 2024-05-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1618-2024

## Citation

> AI Analytics. FDA recall Z-1618-2024. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1618-2024. Source: US FDA. Licensed CC0.

---

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