FDA Medical Device Recalls (openFDA)
Natus Neurology Inc: TENSIVE Conductive Adhesive Gel, REF 016-401600
- Recall number
- Z-1305-2024
- Recalling firm
- Natus Neurology Inc
- Product
- TENSIVE Conductive Adhesive Gel, REF 016-401600
- Status
- Open, Classified
- Initiated
- 2024-02-07
- Posted
- 2024-03-19
- Terminated
- not on file
- 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.
- 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
- 80 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot, serial or model codes
- UDI/DI 00855683006333, Lot Numbers: A0623009
- 510(k) numbers
- ["K852956"]
- PMA numbers
- not on file
- Product code
- GYB
- Firm FEI
- 3010611950
- Firm city
- Middleton
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28