FDAFebruary 7, 2024device
natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
natus neurologynatus
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANatus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph2025-06-18
- FDABrand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No2025-05-07
- FDATENSIVE Conductive Adhesive Gel, REF 016-4016002024-02-07
- FDAExternal Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only2023-11-28
- FDAEDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only2023-11-28
- FDAThe Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various components of th...2022-11-18
- FDAIPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software2021-12-02
- FDARef: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is...2021-01-12
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