TENSIVE Conductive Adhesive Gel — Class II medical device recall Z-1305-2024
Ongoing recall by Natus Neurology Inc, reported 2024-03-27, distributed nationwide. Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall
| Recall number | Z-1305-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Neurology Inc, Middleton, WI, United States |
| Recall initiated | 2024-02-07 |
| Classified | 2024-03-19 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 80 units |
| UPC / GTIN / UDI-DI | 00855683006333 |
| Lot numbers | A0623009 |
| Model numbers | 016-401600 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1305-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.