Z-1305-2024Class II

TENSIVE Conductive Adhesive Gel, REF 016-401600

Name: Z-1305-2024 TENSIVE Conductive Adhesive Gel, REF 016-401600
Creator: Natus Neurology Inc
Published: 2024-02-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-02-07 / Open, Classified / root cause: supplier

FDA source

Natus Neurology Inc began a recall of TENSIVE Conductive Adhesive Gel, REF 016-401600 on 2024-02-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1305-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-07
Posted: 2024-03-19
Recalling firm: Medtronic, Inc.
Product: TENSIVE Conductive Adhesive Gel, REF 016-401600
Product code: GYB Media, Electroconductive
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.
Root cause tag: supplier
FDA root cause: Under Investigation by firm
Action: Natus issued an Urgent Medical Device Recall Notice to its consignees on 02/07/2024 via UPS and email. The notice explained the issue and risk to health. It also requested the consignee cease use, complete and return the form for the replacement of the product.
Quantity in commerce: 80 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UDI/DI 00855683006333, Lot Numbers: A0623009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1305-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1305-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19
Z-1306-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19

Product code GYB

K852956Class IIContact Conductive Adhesive Gel CompositionParker Laboratories, Inc. / cleared 1985-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)