# FDA recall Z-1305-2024

> **Natus Neurology Inc** · Class II · device recall initiated 2024-02-07.

## Product

TENSIVE Conductive Adhesive Gel, REF 016-401600

## Reason for recall

Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They have received five complaints. These customers reported that the gel is too thick, is discolored (darker than usual), and in one instance, patients reported irritation after procedures using the gel.

## Distribution

Worldwide distribution - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-1305-2024
- **Recalling firm:** Natus Neurology Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-07
- **Report date:** 2024-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Middleton, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1305-2024

## Citation

> AI Analytics. FDA recall Z-1305-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1305-2024. Source: US FDA. Licensed CC0.

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