FDA Device recall Z-1305-2024
TENSIVE Conductive Adhesive Gel, REF 016-401600
- FDA Device
- Class II
- ongoing
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class II recall of TENSIVE Conductive Adhesive Gel, REF 016-401600 by Natus Neurology, citing 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 Num….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1305-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-07 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Natus Neurology |
| Distribution | US |
Product
TENSIVE Conductive Adhesive Gel, REF 016-401600
Reason
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.
Identifiers
| code_info | UDI/DI 00855683006333, Lot Numbers: A0623009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1305-2024%22
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